A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite
Phase: NA
Conditions: Cellulite
Sponsor: Galderma R&D

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CLINICAL STUDY PROTOCOL
PROTOCOL NUMBER: 43CASA2006
This document contains confidential, proprietary information
This clinical study protocol contains confidential information belonging to Q-Med AB, part of the
Galderma Group. Except as may be otherwise agreed to in writing, by accepting or reviewing these 
materials, you agree to hold such information in confidence and neither disclose it to any third parties 
(except where required by applicable law) nor use it for any other purpose than in relation to the clinical 
study described herein. No information may be disclosed to any third party without prior written consent 
from Q-Med AB.
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Title Page
A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic acid (PLLA) for the Improvement 
in Appearance of Cellulite.
Clinical Trial Number (CTN): 43CASA2006
SPONSOR:
Q-Med AB
Seminariegatan 21
SE-752 28 Uppsala, Sweden
Telephone:
+46 18 474 90 00
Statements of compliance
The study should be conducted in compliance with the clinical trial agreement, the clinical study protocol, 
good clinical practice (GCP), and applicable regional or national regulations. The international standard for 
clinical study of medical devices for human subjects, ISO14155:2020 should be followed. The International 
Conference on Harmonization (ICH) guideline for GCP (E6 (R2)) should be followed as applicable for 
medical device. The study should be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki1.
1(https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-princsples-for-medical-
researchinvolving-human-subjects/)
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potential) agrees to use an acceptable form of effective birth control for the 
duration of the study and is willing to take a urine pregnancy test at the 
screening visit and prior to all injection visits. Acceptable forms of effective 
birth control methods include:
a. Combined oral contraceptives (estrogens and progesterone) or implanted or 
injectable contraceptives with a stable dose for at least 28 days prior to the 
Baseline visit
b. Hormonal or copper intrauterine device (IUD) inserted at least 28 days prior to 
the Baseline visit
c. Barrier methods of contraception: condom or occlusive cap (diaphragm or 
cervical caps) with spermicidal foam/gel/film/cream/suppository
d. Bilateral tubal ligation prior to the Baseline visit
e. Vasectomized partner (in monogamous relationships) for at least 3 months 
prior to the Baseline visit
f. Strict abstinence (at least one month prior to the baseline visit and agrees to 
continue for the duration of the study or use acceptable form of birth control).
8.
Negative urine pregnancy test for females of childbearing potential at 
screening and all injection visits.
Exclusion Criteria:
The presence of any of the following exclusion criteria will exclude a subject 
from enrollment in the study:
1.
Known/previous allergy or hypersensitivity to any of the Sculptra
constituents.
2.
Known/previous allergy or hypersensitivity to lidocaine and other local 
anesthetics, e.g. amide-type anesthetics, or topical anesthetics or nerve 
blocking agents.
3.
Previous or present multiple allergies or severe allergies, such as
manifested by anaphylaxis or angioedema, or family history of these 
conditions.
4.
Previous treatment/procedure in or near the treatment area: 
a. Previous permanent implant, filler, lifting threads, or autologous fat in the 
treatment area, regardless of time.
b. Previous semi-permanent implants exemplified by Calcium Hydroxylapatite 
(CaHA), poly l-lactic acid (PLLA) in treatment area, regardless of time.
c. Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area 
within 12 months.
d. Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, 
radiofrequency and endermology) in the treatment area within 6 months.
e. Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic 
procedures (e.g. chemical peel) in the treatment area within 6 months.
f. Previous treatment with cryotherapy, lipolytic treatments or liporeduction 
massage in the treatment area within 6 months.
OR is planning to undergo any of these procedures affecting the treatment 
area, at any time during the study.
5.
Previous surgery in or near the treatment area, including but not limited 
to buttock lift or liposuction.
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6.
Scar or skin coloring/bleaching/tattoo that obscures evaluation of the 
treatment area.
7.
Intends to initiate a weight loss program during the study.
8.
Presence of any disease or lesions near or on the area to be treated, e.g.
a. Inflammation, active or chronic infection in or near the treatment area 
b. Psoriasis, eczema, herpes zoster and acanthosis
c. Cancer or precancerous condition (e.g. actinic keratosis)
d. Varicous veins, severe stretchmarks or severe cellulitis 
e. Severe skin laxity, flaccidity, sagging
f. Skin condition in the treatment area that in the Investigator’s opinion could 
interfere with the safety or effectiveness of the study product or injection 
procedure. 
9.
History of bleeding disorders or treatment with anticoagulants or 
inhibitors of platelet aggregation (e.g. aspirin or other Non-Steroidal 
Anti-Inflammatory Drugs (NSAIDs)), Omega-3, or Vitamin E within 
14 days before treatment.
Note: Omega-3 and Vitamin E are acceptable as part of a standard
multivitamin formulation.
10. Treatment with systemic retinoids within 6 months of the Baseline visit, 
chemotherapy, immunosuppressive agents, immunomodulatory therapy 
(e.g. monoclonal antibodies or antiviral treatment for Human 
Immunodeficiency Virus (HIV) or Hepatitis C). Systemic 
corticosteroids (inhaled corticosteroids are allowed) within 3 months 
before treatment.
11. Use of topical corticosteroids, topical prescription retinoids or cellulite 
cream in the treatment area within 1 month of the Baseline visit.
12. History of cancer or previous radiation near or on the area to be treated.
13. HIV positive or active hepatitis.
14. History of or active collagen diseases such as systemic lupus 
erythematosus, rheumatic arthritis, polymyositis, dermatomyositis, skin 
or systemic scleroderma.
15. Tendency to form keloids, hypertrophic scars, or any other healing 
disorder.
16. Woman who is pregnant (confirmed by positive urine pregnancy 
test/serum pregnancy test), breast feeding or intend to become pregnant 
over the duration of the study.
17. Any medical condition that, in the opinion of the Treating Investigator, 
would make the subject unsuitable for inclusion (e.g. a chronic, 
relapsing or hereditary disease, history of disc hernia or lower back 
pain that may interfere with the outcome of the study).
18. Other condition preventing the subject from entering the study in the 
Treating Investigator’s opinion, e.g. subjects not likely to avoid other 
cosmetic treatments in the treatment area, subjects anticipated to be 
unavailable or incapable of understanding the study assessments or 
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having unrealistic expectations of the treatment result.
19. Study center personnel, close relatives of the study center personnel
(e.g. parents, children, siblings, or spouse), or employees and close
relatives of employees at the Sponsor company.
20. Participation in any interventional clinical study within 30 days of 
screening.
Investigational 
Product:
Sculptra, a sterile, freeze-dried, injectable poly-l-lactic acid (PLLA) available in 
367.5 mg dose vials including 150 mg PLLA.
Sculptra is to be reconstituted to 17 mL per vial using SWFI, with the addition of 
1 mL 2% lidocaine hydrochloride.
Comparator/Placebo 
Product:
Not applicable
Treatment area: 
Posterior thighs. In this study, the study product will be administered in the 
treatment area delimited within the following anatomical borders:
Superior border: Infragluteal fold
Lateral border: Illotibial band – posterior border
Medial border: Gracilis muscle – posterior border
Inferior border: 2/3 from infragluteal fold to the popliteal crease.
Treatment regimen:
Three treatment sessions spaced one month (+ 2 weeks) apart. Sufficient amount 
of study product, as determined by the Treating Investigator, should be injected to 
achieve optimal correction, defined as the best correction that could be achieved 
as agreed upon by the Treating Investigator and the subject. Treatment will stop 
when optimal correction has been achieved and subsequent visits will be follow-
up visits.
Maximum recommended dose per session: 6 vials (3 vials per thigh), up to 54 mL 
per thigh. 
The study product is to be injected in the deep dermis or subdermal region (i.e. 
subcutaneously), evenly spread over the entire treatment area. One vial per third 
of the area in each thigh (100 cm2) is recommended.
Mode of 
administration:
Injections should be made using a 25 Gauge (G) 1.5 inch needle into the deep 
dermis or subdermal region (i.e.subcutaneously) , evenly spread over the entire 
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CLINICAL STUDY FLOW CHART
Figure 1 Clinical Study Flow Chart
43CASA2006
N=30 subjects
Visit 1

Day -30 to Day 1
Screening
Visit 2a

Day 1 – Baseline
1st Treatment
Visit 2b

72 hours post-treatment
Telephone Contact 
Visit 3a

Month 1
2nd Treatment (optional)
Visit 3b

72 hours post-treatment
Telephone Contact 
Visit 4a

Month 2
3rd Treatment (optional)
Visit 4b

72 hours post-treatment
Telephone Contact
Visit 5

Month 6
Follow-up
Visit 6

Month 9
Follow-up
Visit 7
Month 12
Follow-up/Early termination
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ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event 
BMI
Body Mass Index
CaHA
Calcium Hydroxylapatite
CMC
Sodium CarboxyMethylCellulose
CSP
Clinical Study Protocol
CTA
Clinical Trial Agreement
eCRF
electronic Case Report Form
CRO
Contract Research Organization
FSFV
First Subject First Visit
G
Gauge
GAIS
Global Aesthetic Improvement Scale
HA
Hyaluronic acid
HIV
Human Immunodeficiency Virus
ICF
Informed Consent Form
IFU
Instructions for use
IUD
Intrauterine Device
IB
Investigator’s Brochure
IPL
Intense Pulsed Light
LSLV
Last Subject Last Visit
NSAID
Non-Steroidal Anti-Inflammatory Drugs
PLLA
Poly-l-lactic acid
RA
Regulatory Authority
REB
Research Ethics Board
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Table of Contents
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
3
SPONSOR SIGNATURES
4
SYNOPSIS
5
CLINICAL STUDY FLOW CHART
11
SCHEDULE OF ASSESSMENTS
12
ABBREVIATIONS AND DEFINITIONS OF TERMS
13
LIST OF TABLES
17
LIST OF FIGURES
17
LIST OF APPENDICES
17
1.
GENERAL INFORMATION
18
2.
BACKGROUND INFORMATION
18
2.1
Medical Background, Indication and Population description
18
2.2
Relevant previous data
19
2.2.1
Non-clinical documentation
19
2.2.2
Clinical documentation
19
2.3
Risks and benefits
19
3.
STUDY OBJECTIVES AND ENDPOINTS
19
3.1
Study Objectives
20
3.1.1
Primary objectives and endpoints
20
3.1.2
Secondary objectives and endpoints
20
3.1.3
Safety objectives and endpoints
20
3.2
Appropriateness of measurements
21
3.3
Clinical Hypothesis
21
4.
STUDY DESIGN
21
4.1
Overall Design
22
4.2
Study rationale and justification for design
22
4.3
Number of subjects and study centers
22
4.4
Study duration
22
4.5
Study visits description and procedures
22
4.5.1
Visit 1, Screening (Day -30 to Day 1)
23
4.5.2
Visit 2a, Baseline and First treatment (Day 1)
23
4.5.3
Visit 2b, Follow up 72-hour telephone call (±24 hours)
24
4.5.4
Visit 3a, Second treatment (1 month (+2 weeks) after Baseline
24
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4.5.5
Visit 3b, Follow up 72-hour telephone call (±24 hours)
25
4.5.6
Visit 4a, Third treatment (1 month (+2 weeks) after second treatment
25
4.5.7
Visit 4b, Follow up 72-hour telephone call (±24 hours)
26
4.5.8
Visit 5, Follow up Month 6 (±2 weeks) after Baseline
26
4.5.9
Visit 6, Follow up Month 9 (±2 weeks) after Baseline
26
4.5.10
Visit 7, Follow up Month 12 (±2 weeks) after Baseline/Early termination
27
4.6
Procedures/Reasons for Subject Discontinuation
27
5.
STUDY POPULATION
28
5.1
Clinical Study Population Characteristics
28
5.1.1
Inclusion criteria
28
5.1.2
Exclusion criteria
29
5.1.3
Medical history
31
5.1.4
Prior and concomitant therapies
31
5.2
Subject Identification Number
32
6.
STUDY INTERVENTION
32
6.1
Description of the Investigational Device
32
6.1.1
Investigational device
32
6.1.2
Reference product
33
6.1.3
Additional products and materials
33
6.2
Packaging and Labelling
33
6.3
Instructions for Use and Administration
33
6.3.1
Treatment procedure
34
6.3.2
Treatment regimen (dose and interval)
35
6.3.3
Post-treatment care
35
6.4
Supplies Management
35
6.4.1
Product accountability
35
6.4.2
Storage of Study Product
36
6.4.3
Dispensing and Return
36
6.4.4
Treatment compliance
36
6.4.1
Case report form recordings
36
6.5
Randomization
36
6.6
Blinding
36
6.7
Post-trial provisions
37
7.
STUDY ASSESSMENTS AND PROCEDURES
37
7.1
Efficacy Assessments
37
7.1.1
Photography
37
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7.1.2
GAIS
37
7.1.3
38
7.1.4
Questionnaires
40
7.1.5
Volume analysis, surface contour, skin texture/roughness and circumference of the thigh assessments using 3D 
imaging
43
7.1.6
Ultrasound
43
7.1.7
Return to daily activities
43
7.2
Safety Assessments
43
7.2.1
Subject Diary Data
43
7.2.2
Laboratory assessments
44
7.2.3
Pain assessment
44
7.2.4
Device palpability
44
7.2.5
Adverse events
44
7.2.6
Follow-up of unresolved events ongoing at termination of the study
49
7.2.7
Follow-up of events occurring after subject termination of the study
49
7.2.8
Anticipated adverse events
49
7.2.9
Pregnancy
49
7.2.10
Device deficiencies
50
7.2.11
Stopping rule
50
8.
STATISTICAL DESIGN AND ANALYSIS
50
8.1
General
50
8.2
Analysis populations
51
8.3
Demographics, baseline assessments, and subject characteristics
51
8.4
Data Transformations
51
8.5
Efficacy analysis
51
8.5.1
Primary analysis
51
8.5.2
Secondary analysis
52
8.6
Safety analysis
52
8.7
Handling of missing data
53
8.8
Interim analysis
53
8.9
Data monitoring committee
53
8.10
Withdrawals and deviations
53
8.11
Sample size
53
9.
DATA MANAGEMENT
53
9.1
Protection of personal data
53
9.2
Data Collection
54
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9.2.1
Data entry
54
9.2.2
The query process
55
9.2.3
User identification
55
9.2.4
Audit trail
55
9.2.5
Source documentation
55
9.3
Archiving / Record keeping
56
10.
PROTOCOL DEVIATIONS
56
11.
QUALITY CONTROL AND QUALITY ASSURANCE
56
11.1
Personnel Training
56
11.2
Quality Control / Clinical Monitoring
56
11.3
Quality assurance / Audit / Inspections
57
12.
ETHICS
57
12.1
Application to Research Ethics Board and Regulatory Authority
57
12.2
Subject information and consent
57
13.
FINANCING, INDEMNIFICATION AND INSURANCE
58
14.
SUSPENSION OR PREMATURE TERMINATION
58
15.
PUBLICATION POLICY
58
16.
REFERENCES
60
17.
APPENDICES
62
SIGNED AGREEMENT OF THE CLINICAL STUDY PROTOCOL
63
List of tables
Table 1 Fitzpatrick Skin Types (FST)............................................................................................................23
Table 2 GAIS..................................................................................................................................................38
Table 3 Grading for subject diary data...........................................................................................................44
List of Figures
Figure 1 Clinical Study Flow Chart................................................................................................................11
Figure 2 Schedule of Assessments .................................................................................................................12
Figure 3 Treatment area..................................................................................................................................34
Figure 4 
List of Appendices
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3.1
Study Objectives
The effectiveness objective is to evaluate the effectiveness of Sculptra for the improvement in appearance
of cellulite in the posterior thighs.
3.1.1
Primary objectives and endpoints
Percentage of responders, defined as having at least “Improved” on both thighs according to the Global 
Aesthetic Improvement Scale (GAIS), as assessed live by the Treating Investigator, at Month 9.
3.1.2
Secondary objectives and endpoints
1.
Percentage of responders, defined as having at least “Improved” according to the Global 
Aesthetic Improvement Scale (GAIS), as assessed live by the Treating Investigator for each 
posterior thigh separately, at Month 1, 2, 6 and 12.
2.
Percentage of responders, defined as having at least “Improved” according to the Global 
Aesthetic Improvement Scale (GAIS), as assessed by photography by the subject at Month 
1, 2, 6, 9 and 12 for each posterior thigh separately.
3.1.3
Safety objectives and endpoints
The safety objective is to evaluate the safety of Sculptra for the improvement in appearance of cellulite in 
the posterior thighs. 
The safety endpoints are:
1.
Incidence, intensity, time to onset and duration of adverse events (AEs) collected 
throughout the study period.
2.
Incidence, intensity, time to onset and number of days of pre-defined expected post-
treatment events collected using subject diaries for 28 days from each treatment.
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4.5.1 Visit 1, Screening (Day -30 to Day 1)
The screening visit and baseline visit (Day 1) may be performed on the same day. The following 
activities and screening assessments will be performed within 30 days priorto baseline.
o
Obtain Informed Consent prior to conducting any study specific procedure.
o
Assess eligibility: Review inclusion/exclusion criteria.
o
Obtain demographic data: date of birth, height, weight, gender, ethnicity, race and Fitzpatrick 
Skin Type (FST).
- FST is a skin classification system that categorizes different skin colors, and their reactions 
to ultraviolet light.18 19. For determination of the FST, see Table 1 below.
- Height may be self-reported, weight is to be measured at clinic. 
o
Record the subject’s medical history (including any prior dermatological procedures or 
implants).
o
Record the subject’s prior and concomitant therapies.
o
Perform Urine Pregnancy test for all females of childbearing potential (prior to treatment). Test 
result must be negative for the subject to be eligible for treatment.
o
Schedule the baseline and treatment visit (Day 1) if performed on a different day than screening.
Table 1 Fitzpatrick Skin Types (FST)
Skin type
Skin color
Skin characteristics
I
White; very fair; red or blond hair; blue
eyes; freckles
Always burns, never tans
II
White; fair; red or blond hair; blue, hazel or
green eyes
Usually burns, tans with difficulty
III
Cream white; fair with any eye or hair color;
very common
Sometimes mild burn, gradually tans
IV
Brown; typical Mediterranean Caucasian skin
Rarely burns, tans with ease
V
Dark brown; Middle Eastern skin types
Very rarely burns, tans very easily
VI
Black
Never burns, tans very easily
o
4.5.2 Visit 2a, Baseline and First treatment (Day 1)
The screening visit and baseline visit (Day 1) may be performed on the same day. If Screening visit and
Baseline visit are not performed on the same day, the following should be repeated:
o
Review for changes in concomitant therapies.
o
Re-confirm eligibility criteria.
o
Perform Urine Pregnancy test for all females of childbearing potential (prior to treatment). Test 
result must be negative for the subject to be eligible for treatment.
Once the subject is deemed eligible by the Treating Investigator, the following procedures should be 
completed:
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o
Obtain pre-treatment Photography.
o
Perform pre-treatment ultrasound.
o
Assess severity of depressions and undulations associated with cellulite using the GCTS -
Treating Investigator.
o
Sculptra administration.
o
.
o
Evaluate the subject for post-treatment AEs - Treating Investigator.  
o
Evaluate for device deficiencies - Treating Investigator.
o
Dispense diary and instruct subject on daily Diary completion. Remind subject to bring the 
Diary to the next study center visit.
o
Evaluate the subject for device palpability – Treating Investigator. 
o
Inform subject about the follow-up telephone call 72-hours (±24 hrs) after the visit.
o
Schedule the next visit 1 month (+2 weeks) after baseline.
4.5.3 Visit 2b, Follow up 72-hour telephone call (±24 hours) 
o
Interview subject regarding any concomitant therapies.
o
Interview subject regarding any AEs that have occurred since receiving treatment. If AEs are 
reported, notify the Investigator immediately and determine whether subject should return to 
the study center for an unscheduled visit. The Investigator should assess all reported AEs in a 
timely manner.
o
Interview subject regarding the diary completion and reported events since receiving treatment. 
Remind subject to complete the diary daily and bring it to the next on-site visit.
4.5.4 Visit 3a, Second treatment (1 month (+2 weeks) after Baseline
o
Review for changes in concomitant therapies.
o
Collect and review subject diary.
o
Obtain pre-treatment Photography (2D and 3D).
o
Assess GAIS – Subject and Treating Investigator.
o
Assess severity of depressions and undulations associated with cellulite using the GCTS -
Treating Investigator.
o
Assess whether optimal treatment result has been obtained (as agreed by the Treating 
Investigator and Subject). If a second treatment is to be performed, confirm eligibility criteria:
o
Perform Urine Pregnancy test for all females of childbearing potential (prior to 
treatment). Test result must be negative for the subject to be eligible for treatment
o
No treatment should be given in the subject has a disease or condition described in the 
exclusion criteria, or an ongoing treatment related AE that in the opinion of the 
Treating Investigator would be worsened by a treatment.
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For subjects who receive a second treatment: 
o
Sculptra administration.
o
. 
o
Evaluate the subject for post-treatment AEs - Treating Investigator.  
o
Evaluate for device deficiencies - Treating Investigator.
o
Dispense diary and instruct subject on daily Diary completion. Remind subject to bring the 
Diary to the next study center visit.
o
Evaluate the subject for device palpability – Treating Investigator. 
o
Inform subject about the follow-up telephone call 72-hours (±24 hrs) after the visit.
o
Schedule the next visit 1 month (+2 weeks) after second treatment.
4.5.5 Visit 3b, Follow up 72-hour telephone call (±24 hours)
o
Interview subject regarding any concomitant therapies.
o
Interview subject regarding any AEs that have occurred since receiving treatment. If AEs are 
reported, notify the Investigator immediately and determine whether subject should return to 
the study center for an unscheduled visit. The Investigator should assess all reported AEs in a 
timely manner.
o
Interview subject regarding the diary completion and reported events since receiving treatment. 
Remind subject to complete the diary daily and bring it to the next on-site visit.
4.5.6 Visit 4a, Third treatment (1 month (+2 weeks) after second treatment 
o
Review for changes in concomitant therapies.
o
Collect and review subject diary.
o
Obtain pre-treatment Photography (2D and 3D).
o
Assess GAIS – Subject and Treating Investigator.
o
Assess severity of depressions and undulations associated with cellulite using the GCTS -
Treating Investigator.
o
Assess whether optimal treatment result has been obtained (as agreed by the Treating 
Investigator and Subject). If a third treatment is to be performed, confirm eligibility criteria:
o
Perform Urine Pregnancy test for all females of childbearing potential (prior to 
treatment). Test result must be negative for the subject to be eligible for treatment.
o
No treatment should be given in the subject has a disease or condition described in the 
exclusion criteria, or an ongoing treatment related AE that in the opinion of the 
Treating Investigator would be worsened by a treatment.
For subjects who receive a third treatment:
o
Sculptra administration.
o
. 
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o
Evaluate the subject for post-treatment AEs - Treating Investigator.  
o
Evaluate for device deficiencies - Treating Investigator.
o
Dispense diary and instruct subject on daily Diary completion. Remind subject to bring the 
Diary to the next study center visit.
o
Evaluate the subject for device palpability – Treating Investigator. 
o
Inform subject about the follow-up telephone call 72-hours (±24 hrs) after the visit.
o
Schedule the next visit at Month 6 (2 weeks) after second treatment.
4.5.7 Visit 4b, Follow up 72-hour telephone call (±24 hours) 
o
Interview subject regarding any concomitant therapies.
o
Interview subject regarding any AEs that have occurred since receiving treatment. If AEs are 
reported, notify the Investigator immediately and determine whether subject should return to 
the study center for an unscheduled visit. The Investigator should assess all reported AEs in a 
timely manner.
o
Interview subject regarding the diary completion and reported events since receiving treatment. 
Remind subject to complete the diary daily and bring it to the next on-site visit.
4.5.8 Visit 5, Follow up Month 6 (±2 weeks) after Baseline
o
Obtain weight.
o
Review the subject’s concomitant therapies.
o
Obtain Photography (2D and 3D).
o
Evaluate the subject for AEs - Treating Investigator.  
o
Collect and review subject diary (only applicable for subjects who received a third treatment).
o
o
Evaluate the subject for device palpability – Treating Investigator. 
o
Assess GAIS – Subject and Treating Investigator.
4.5.9 Visit 6, Follow up Month 9 (±2 weeks) after Baseline
o
Obtain weight.
o
Review the subject’s concomitant therapies.
o
Obtain Photography (2D and 3D).
o
Evaluate the subject for AEs - Treating Investigator.  
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o
o
Evaluate the subject for device palpability – Treating Investigator. 
o
Assess GAIS – Subject and Treating Investigator.
4.5.10 Visit 7, Follow up Month 12 (±2 weeks) after Baseline/Early termination
o
Obtain weight.
o
Review the subject’s concomitant therapies.
o
Perform Urine Pregnancy test for all females of childbearing potential.
o
Obtain Photography (2D and 3D).
o
Evaluate the subject for AEs - Treating Investigator.  
o
o
Evaluate the subject for device palpability – Treating Investigator.
o
Assess GAIS – Subject and Treating Investigator.
4.6
Procedures/Reasons for Subject Discontinuation
Each subject should be advised in the Informed Consent Form (ICF) that the subject has the right to 
withdraw from the study at any time, for any reason, without prejudice. Subjects may also be discontinued 
from this study if the investigator determines that it is in the subject’s best interest to do so and may be 
withdrawn at the investigator discretion at any time.
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The withdrawal criteria are:

Medical Reasons
If the subject suffers from a medical condition and/or AE that, in the 
judgment of the Investigator makes it medically necessary to withdraw the 
subject. The specific rationale for Investigator-initiated withdrawal of a 
subject for medical reasons should document the specific condition for 
withdrawing the subject.

Withdrawal by 
Subject:
Includes consent withdrawal, subject relocation, schedule conflicts. A 
subject can withdraw their consent to participate in the study at their own 
request or be withdrawn from participation in the study at the request of 
their legally authorized representative at any time for any reason.

Lost to follow-up:
If a subject does not return for a scheduled visit, reasonable effort shall be 
made to contact that subject, confirm with three documented phone calls 
and a certified letter (delivery receipt requested) without answer before 
declaring the subject lost to follow-up.

Other:
This category is to be used for a subject who discontinues due to a reason 
other than as specified in the pre-defined categories above. Explain the 
reason for discontinuation.
The reason and date for withdrawal should be documented in the subject’s source documents and in the 
electronic case report forms (eCRF)s. When possible, an explanatory comment should be added to further 
explain the reason for the withdrawal. If withdrawal of a subject occurs during a regular study visit, the 
eCRF for that specific visit shall be completed as far as possible.
If withdrawal of a subject occurs between regular study visits, the subject should when possible 
(irrespective of the reason for withdrawal) be scheduled for a termination visit to document subject 
outcome for the secondary endpoints.
If a subject is withdrawn from the study, all data collected until the time of withdrawal will be used in the 
analyses. Subjects who receive product and are withdrawn or discontinued from the study will not be 
replaced. For AEs still ongoing at the time of withdrawal, see section 7.2.6.
5.
STUDY POPULATION
Approximately 30 women with intent to undergo treatment to improve appearance of cellulite in the 
posterior thighs will be included in this study.
5.1
Clinical Study Population Characteristics
5.1.1 Inclusion criteria
The subjects must meet the following criteria to be eligible for the study:
1. Subjects willing to comply with the requirements of the study and providing a signed written 
informed consent.
2. Immune-competent adult women 18 years of age and older.
3. Body Mass Index (BMI) ≥18.5 and ≤25.
4. Subjects with intent to undergo treatment to improve appearance of cellulite in the posterior thighs.
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5.
 
6. Subject that in the opinion of the PI could benefit from treatment to improve appearance of
cellulite.
7. Postmenopausal for at least 1 year or (if the subject is of childbearing potential) agrees to use an 
acceptable form of effective birth control for the duration of the study and is willing to take a 
urine pregnancy test at the screening visit and prior to all injection visits. Acceptable forms of 
effective birth control methods include:
a.
Combined oral contraceptives (estrogens and progesterone) or implanted or injectable 
contraceptives with a stable dose for at least 28 days prior to the Baseline visit
b.
Hormonal or copper intrauterine device (IUD) inserted at least 28 days prior to the Baseline
visit
c.
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical caps) with
spermicidal foam/gel/film/cream/suppository
d.
Bilateral tubal ligation prior to the Baseline visit
e.
Vasectomized partner (in monogamous relationships) for at least 3 months prior to the Baseline
visit
f.
Strict abstinence (at least one month prior to the baseline visit and agrees to continue for the 
duration of the study or use acceptable form of birth control).
8. Negative urine pregnancy test for females of childbearing potential at screening and all
injection visits.
5.1.2 Exclusion criteria
The presence of any of the following exclusion criteria will exclude a subject from enrollment in the
study:
1.
Known/previous allergy or hypersensitivity to any of the Sculptra constituents.
2.
Known/previous allergy or hypersensitivity to lidocaine and other local anesthetics, e.g. amide-
type anesthetics, or topical anesthetics or nerve blocking agents.
3.
Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or
angioedema, or family history of these conditions.
4.
Previous treatment/procedure in or near the treatment area: 
a)
Previous permanent implant, filler, lifting threads, or autologous fat in the treatment area, 
regardless of time.
b)
Previous semi-permanent implants exemplified by Calcium Hydroxylapatite (CaHA), poly l-lactic 
acid (PLLA) in treatment area, regardless of time.
c)
Previous Hyaluronic acid (HA) filler or collagen filler in the treatment area within 12 months.
d)
Previous energy based aesthetic procedures (e.g. laser, intense pulsed light, radiofrequency and 
endermology) in the treatment area within 6 months.
e)
Previous mechanical (e.g. dermabrasion, needling) or chemical aesthetic procedures (e.g. 
chemical peel) in the treatment area within 6 months.
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f)
Previous treatment with cryotherapy, lipolytic treatments or liporeduction massage in the 
treatment area within 6 months.
OR is planning to undergo any of these procedures affecting the treatment area, at any time during
the study.
5.
Previous surgery in or near the treatment area, including but not limited to buttock lift or liposuction.
6.
Scar or skin coloring/bleaching/tattoo that obscures evaluation of the treatment area.
7.
Intends to initiate a weight loss program during the study.
8.
Presence of any disease or lesions near or on the area to be treated, e.g.
a. Inflammation, active or chronic infection in or near the treatment area 
b. Psoriasis, eczema, herpes zoster and acanthosis
c. Cancer or precancerous condition (e.g. actinic keratosis)
d. Varicous veins, severe stretchmarks or severe cellulitis
e. Severe skin laxity, flaccidity, sagging
f.
Skin condition in the treatment area that in the Investigator’s opinion could interfere with the
safety or effectiveness of the study product or injection procedure. 
9.
History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation 
(e.g. aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)), Omega-3, or Vitamin E 
within 14 days before treatment. 
Note: Omega-3 and Vitamin E are acceptable as part of a standard multivitamin formulation.
10. Treatment with systemic retinoids within 6 months of the Baseline visit, chemotherapy, 
immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies or antiviral 
treatment for Human Immunodeficiency Virus (HIV) or Hepatitis C). Systemic corticosteroids 
(inhaled corticosteroids are allowed) within 3 months before treatment.
11. Use of topical corticosteroids, topical prescription retinoids or cellulite cream in the treatment 
area within 1 month of the Baseline visit.
12. History of cancer or previous radiation near or on the area to be treated.
13. HIV positive or active hepatitis.
14. History of or active collagen diseases such as systemic lupus erythematosus, rheumatic arthritis, 
polymyositis, dermatomyositis, skin or systemic scleroderma.
15. Tendency to form keloids, hypertrophic scars, or any other healing disorder.
16. Woman who is pregnant (confirmed by positive urine pregnancy test/serum pregnancy test), 
breast feeding or intend to become pregnant over the duration of the study.
17. Any medical condition that, in the opinion of the Treating Investigator, would make the subject 
unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease, history of disc hernia or 
lower back pain that may interfere with the outcome of the study).
18. Other condition preventing the subject from entering the study in the Treating Investigator’s 
opinion, e.g. subjects not likely to avoid other cosmetic treatments in the treatment area, subjects 
anticipated to be unavailable or incapable of understanding the study assessments or having
unrealistic expectations of the treatment result.
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19. Study center personnel, close relatives of the study center personnel (e.g. parents, children, 
siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
20. Participation in any interventional clinical study within 30 days of screening.
5.1.3 Medical history
History of relevant surgical events and medical conditions should be documented (including
any prior dermatological procedures or implants) in the eCRF using medical terminology.
5.1.4 Prior and concomitant therapies
Prior therapies are defined as therapies that have been used within 30 days preceding the screening visit or 
within the timelines specified in the Inclusion/Exclusion criteria, and then stopped prior to the screening 
visit.
Concomitant therapies are defined as follows:

any existing therapies ongoing at the time of the screening visit,

any changes to existing therapies (such as changes in dose or formulation) during the course of the 
study, or

any new therapies received by the subject since the screening visit
5.1.4.1 Recording
Prior and concomitant therapies are to be recorded on the appropriate form in the eCRF. Concomitant 
therapies are to be recorded, reviewed, and updated at each visit. Any new concomitant therapy or 
modification of an existing therapy may be linked to an AE. A corresponding AE form must be completed 
to account for the change in therapy, except in some cases such as therapy used for prophylaxis, dose 
modification for a chronic condition.
5.1.4.2 Authorized concomitant therapies
Unless listed in prohibited concomitant therapies (Section 5.1.4.3), all therapies are authorized.
5.1.4.3 Prohibited concomitant therapies
The following therapies are prohibited during the study because they may interfere with the effectiveness
and/or safety assessments of the study product(s) and/or injection procedure:

Anticoagulants or inhibitors of platelet aggregation that have the ability to prolong bleeding times
(e.g. aspirin, NSAIDs 20), Omega-3 or Vitamin E should not be used within 14 days before any 
treatment to avoid increased bruising or bleeding at injection sites. Omega 3 and Vitamin E are 
acceptable only as part of a standard multivitamin formulation.

The study product contains lidocaine, but additional local anesthesia may be used. Lidocaine should
however be used with caution in subjects receiving other local anesthetics or agents structurally
related to amide-type anesthetics, e.g. certain antiarrhythmics, as the systemic toxic effects can
be additive.

Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory 
therapy (e.g. monoclonal antibodies or antiviral treatment for HIV or Hepatitis C). Systemic 
corticosteroids within 3 months before treatment. Inhaled corticosteroids are allowed.
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
Topical corticosteroids, topical prescription retinoids or cellulite cream in the treatment area within 
1 month of the Baseline visit

Planned aesthetic surgery in the thigh or gluteal area.

Tissue augmenting therapy, contouring or revitalization treatment with fillers, fat-injections, 
collagen, CaHa, PLLA or lifting threads, tissue grafting, tissue augmentation with permanent 
implants, silicone or fat in the thigh area.

Needling, mesotherapy, lipolytic injection, liporeduction massage, intense pulsed light (IPL), 
radiofrequency, endermology, ultrasound, cryotherapy, laser or light treatment, photo modulation, 
chemical peeling, dermabrasion or other ablative/non-ablative procedures are prohibited in the 
thigh area.

Tattoo or skin bleaching in the posterior thigh.

Participation in any interventional clinical study. 
If a prohibited therapy becomes a necessary treatment for the safety or best interest of the subject, the 
Sponsor should be notified, time permitting, to discuss possible alternatives prior to administration of a 
prohibited therapy.
If a subject receives prohibited therapy during the clinical study, the Sponsor should be notified to discuss 
the pertinence and the modalities for the subject to continue in the clinical study.
5.2
Subject Identification Number
Prior to any study procedures being conducted, the subject must sign the ICF. Each subject will be assigned 
a subject number that will be allocated in ascending order within each study center. A screen failure is a 
subject who signed the ICF but never enrolled (i.e. received treatment) in the study. For screen failures, the 
subject source documents should indicate which assessments have been made and the reason why the 
subject was determined to be a screen failure. A screen failure should not be re-entered in the study. For the 
duration of the clinical study, each subject will be identified using the subject number for all documentation 
and discussion.
6.
STUDY INTERVENTION
6.1
Description of the Investigational Device
6.1.1 Investigational device
The term “study product” refers to Sculptra. The study product will be provided by Sponsor.
Sculptra is an injectable implant that contains microparticles of PLLA, a biocompatible, biodegradable, 
synthetic polymer from the alpha-hydroxy-acid family. Sculptra is reconstituted prior to use by the addition 
of Sterile Water for Injection (SWFI), USP to form a sterile non-pyrogenic suspension. Each vial of dry 
powder contains:

150 mg poly-L-lactic acid (PLLA)

90 mg sodium carboxymethylcellulose (CMC) 

127.5 mg mannitol
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6.1.2 Reference product
Not applicable.
6.1.3 Additional products and materials
Needles for injection, 25G 1.5-inch BD needles, will be supplied by the Sponsor. The needle is approved 
for use in Canada.
The following will be supplied by the study centers:
•
Sterile Water for Injection (SWFI), USP, 20 mL
•
Single-use 5 mL sterile syringes 
•
Single-use 20 mL sterile syringes 
•
Fluid Dispensing Connector
•
Single-use 1 mL sterile syringe
•
18 G sterile needles 
•
Single-use 3-5 mL (depending on Investigator’s preference) sterile syringes 
•
Antiseptic
•
Lidocaine HCl 2%
(Note: The reconstituted study product contains lidocaine, but additional topical or local anesthesia may
be used at the discretion of the Treating Investigator before the treatment. If additional anesthesia is used, 
potential local anesthesia toxicity should be taken into consideration. The maximum allowable safe dose of 
lidocaine is 3-4.5 mg/kg. Type of anesthesia, administration route, product name, and quantity used must 
be recorded in the eCRF.)
6.2
Packaging and Labelling
Sculptra is supplied as a sterile freeze-dried preparation for injection in a clearglass vial, which is sealed 
by a penetrable stopper, covered by an aluminum seal with a flip-off cap. Each carton of Sculptra contains 
one vial.
Each vial of Sculptra is packaged for single use only. 
Labelling will be performed according to Health Canada, Food and Drugs Act (FDA), Part 3 of the 
Medical Devices Regulations section 86 on labelling. The carton will be labelled with lot number, 
expiration date, CTN number, name of the device, name of manufacturer and the following:
“Investigational Device. To be used by Qualified Investigators only.”
“Instrument de recherche. Réservé uniquement à l’usage de chercheurs compétents”
Detailed product information is provided in the study IFU.
6.3
Instructions for Use and Administration
The study product is reserved for use by Treating Investigators who are experienced in treating cellulite in
the posterior thigh area and who have been trained in the appropriate injection techniques. Training will be 
provided by the Sponsor.
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Before treatment the subject will be informed about the expected post-treatment events that should be 
recorded in the subject diary and potential risks involved with the treatment and when to contact the
Investigator in case of emerging symptoms.
The investigator must be trained on, and have at hand, the relevant clinical practice guidelines 15 and the 
actions to be taken if intravascular complications or embolic events occur. The treating physician should 
also review the Intravascular Injection Treatment Protocol 16 provided separately as a supportive tool in the 
Investigator file.
Detailed information regarding the treatment procedure, treatment regimen and post-treatment care
including subject instructions are provided below and in the IFU.
6.3.1 Treatment procedure 
Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to 
prevent cross-infections should be observed at all times including the use of disposable gloves during the 
injection procedure. The treatment site should be cleaned with a suitable antiseptic solution.
The study product contains lidocaine hydrochloride, but additional topical or local anesthesia or an ice pack 
may be used at the discretion of the Treating Investigator to further reduce pain on injection. If (topical or 
local) anesthetic or ice is used, the area should be cleaned after anesthetic is removed. The use of anesthetic 
or ice should be recorded in the source documentation and in the eCRF.
The boundaries of the treatment area are the infragluteal fold superiorly, the illotibial band laterally, the 
gracilis muscle medially and 2/3 from infragluteal fold to the popliteal crease inferiorly, see Figure 3. 
Figure 3 Treatment area
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The study product shall be reconstituted according to instructions in the IFU. 
Injections should be made using a 25 Gauge (G), 1.5 inch needle into the deep dermis or subdermal region 
(i.e. subcutaneously), evenly spread over the entire treatment area, with a fanning, asterisks or short linear 
threading technique with a distance of 1-2 cm using 0.05–0.1 mL per injection point. In some areas with
marked lipoatrophy, a linear retrograde technique with cross sticks can be done in order obtain better 
correction of the skin depression.
One vial per third of the area in each thigh (100 cm2) is recommended.
The needle should be changed when blunt. The number of needles used shall be recorded in the eCRF.
6.3.2 Treatment regimen (dose and interval)
Eligible subjects will receive a single regimen of Sculptra. A single regimen consists of three injection 
sessions with one-month (+2 weeks) intervals. The first treatment will be administered on Day 1/Baseline 
visit, the second treatment at Month 1, and the third treatment at the Month 2 visit. Sufficient amount of
study product, as determined by the Treating Investigator, should be injected to achieve optimal correction, 
defined as the best correction that could be achieved as agreed upon by the Treating Investigator and the 
subject. Treatment will stop when optimal correction has been achieved and subsequent visits will be 
follow-up visits. The maximum recommended dose per session is six (6) vials, three (3) vials per thigh. The 
maximum volume injected per thigh is up to 54 mL.
Treatment will not be performed if the subject has a disease or condition described in the exclusion criteria, 
or an ongoing treatment-related AE that in the opinion of the Treating Investigator would be worsened by a 
treatment.
6.3.3 Post-treatment care
The injected sites could be gently massaged by the treating Investigator to conform to the contour of the 
surrounding tissues. Topical cooling may be applied to reduce initial swelling and bruising. After the 
injection, some common injection-related reactions might occur. These reactions include erythema, 
swelling, pain, itching, bruising or tenderness at the implant site. Typically, resolution is spontaneous 
within one week after injection into the skin.
Subjects should be advised not to do vigorous exercise or have vigorous massage within 3 days after 
injection and to avoid exposing the treated area to heat (sunbathing, ultraviolet-lamp exposure, sauna, steam 
baths, etc.) until any signs of initial swelling and redness have resolved.
6.4
Supplies Management
6.4.1 Product accountability
The study products will be released to the PI or his/her authorized designee after study approvals have been 
received from the REB and RA and the Clinical Trial Agreement (CTA) has been signed by all parties.
The PI must ensure that the study products are kept in a secure location, with access limited to those 
authorized by the PI.
The study product must be traceable from the manufacturer to their use in subjects until return or disposal. 
It is therefore important that the PI maintains accurate product accountability records, i.e. documentation of 
the physical location of all study products, deliveries, and return of study product between the Sponsor and 
the PI, and documentation of administration of product to the subject. A shipping record shall be kept of all 
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study product received from the Sponsor; including the product name, date received, lot number, expiration 
date, and amount received. In addition, dispensing logs shall be maintained including the product name, lot
number, expiry date, dispense date, the number of vials used, the subject receiving study product, and 
number of vials left in stock at the study center.
When the study is completed, all unused or expired study product at each study center shall be returned to 
the Sponsor for destruction or be destroyed locally at the study center, with proper documentation, after 
agreement with the Sponsor. Any malfunctioning study products shall be reported as described in Section
7.2.10.
Product deliberately or accidentally destroyed during shipment or at a study center shall be accounted for 
and documented. Used syringes, vials, needles, and any opened unused material must be discarded
immediately after the treatment session and must not be reused due to risk for contamination of the unused 
material and the associated risks including infections according to standard procedures at the study center. 
Disposal of hazardous material, i.e. syringes and needles, must conform to applicable laws and regulations.
All study product(s) sent to the PI will be accounted for and no unauthorized use is permitted.
6.4.2 Storage of Study Product
Sculptra powder should be stored at controlled room temperature (15-30°C) away from heat. Upon 
reconstitution, Sculptra should be used immediately. Do not freeze.
6.4.3 Dispensing and Return
Not applicable, the treatment will be administered by the Treating Investigator at the study center and be 
documented in the accountability records.
6.4.4 Treatment compliance
Not applicable, the treatment will be administered by the Treating Investigator at the study center and be 
recorded in the eCRF.
6.4.1 Case report form recordings
The following should be recorded in the eCRF:

Date and time of completed injection

Amount of study product per thigh and session, 

Needle size and number of needles used

Injection technique used

Treatment area

Additional local or topical anesthesia
6.5
Randomization
Not applicable, all eligible subjects consenting to participate in the study will receive study product. 
6.6
Blinding
Not applicable.
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6.7
Post-trial provisions
In time, the implant will be degraded in the body and additional treatments will be necessary to maintain 
the aesthetic result. 
7.
STUDY ASSESSMENTS AND PROCEDURES
7.1
Efficacy Assessments
The methods for collecting effectiveness data are described in this section. To minimize inter-observer 
variability, every effort should be made to ensure that preferably the same individual who made the initial 
baseline assessments complete all corresponding follow-up evaluations.
The methods for collecting effectiveness data are:
•
Photography
•
Time to return to daily activities after treatment will be assessed using subject diaries.
•
Global aesthetic improvement by Treating Investigator and Subject using GAIS.
7.1.1 Photography
Photographs will be taken in a standardized way to document the condition at baseline, for effectiveness
assessments as indicated in Figure 2 Schedule of Assessments, and to document AEs in the treated area. 
The subject will be standing and wearing a standardized photographic garment.
Camera equipment will be provided by the Sponsor or their designee. Study center personnel designated to 
take photographs shall be thoroughly trained in the equipment and techniques before study start. The same
photographic equipment and standardized setting must be used at each visit (e.g. distance, light, position). 
Instructions for photography are provided in a separate photography manual.
7.1.2 GAIS
The 7-graded GAIS will be used to assess the aesthetic improvement of cellulite by the Treating 
Investigator and the subject. The treating Investigator will assess the aesthetic improvement live by 
comparing to a photograph taken at the baseline visit before the first treatment. The subject will assess the 
aesthetic improvement by comparing a photograph taken before the first treatment at the baseline visit to a 
photograph from the current visit. The overall treatment area will be assessed for the right and left posterior 
thigh separately. The Treating Investigator and the subject will, independently of each other, respond to the 
question: “How would you describe the aesthetic improvement today compared to the photograph taken 
before treatment?” by using the respective categorical scale below in Table 2 GAIS.
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Table 2 GAIS
Rating (Treating Investigator and 
subject)
Description (only for Treating Investigator)
Very much improved
Optimal aesthetic result for the implant for this subject.
Much improved
Marked improvement in appearance from the initial condition, but 
not completely optimal for this subject. 
Improved
The appearance is improved from the initial condition.
No change
The appearance is essentially the same as baseline.
Worse
The appearance is worse than the initial condition.
Much worse
Marked worsening in appearance from the initial condition.
Very much worse
Obvious worsening in appearance from the initial condition.
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7.1.5 Volume analysis, surface contour, skin texture/roughness and circumference of the thigh 
assessments using 3D imaging
Volume analysis (surface relief changes), surface contour, skin texture/roughness and circumference of the 
thigh will be assessed using 
and software. The assessment should be made for each 
thigh separately. 3D imaging should be performed at baseline, Month 6, Month 9 and Month 12. Camera 
equipment will be provided by the Sponsor or their designee. Further details regarding the 3D imaging
procedure will be specified in a separate user guide. Study centers should follow the maintenance 
instructions from the equipment manufacturer and keep records of maintenance in the investigator file.
7.1.6 Ultrasound
Dermal thickness will be assessed using ultrasound as indicated in the Schedule of Assessments in Figure 2.
The assessment should be made for each thigh separately. Ultrasound equipment will be supplied by the 
Sponsor or their designee to the study centers. Further instructions regarding the equipment and procedure 
will be specified in a separate user guide.
7.1.7 Return to daily activities
Time to return to daily activities after treatment will be assessed using subject diaries for 28 days after each 
treatment.
7.2
Safety Assessments
The methods for collecting safety data are described in this section and include: 
The methods for collecting safety data are:
•
Subject Diary data
•
Laboratory assessments
•
•
Device palpability assessment
•
Adverse Event reporting
•
Device deficiency reporting
7.2.1 Subject Diary Data
A subject diary will be dispensed to all subjects for daily completion for 28 days beginning on injection day 
for each treatment with direct questioning for injection site responses: pain, tenderness, redness, bruising, 
swelling, itching and other. The presence and maximum intensity (grading for subject diary in Table 3) 
shall be assessed for the treated area.
Injection site responses that have not been pre-defined in the diary may also be recorded in the diary under 
“other”.
Diary data will be counted and displayed separately from other AE data. All pre-defined diary events 
ongoing at Day 28, shall be followed up until resolved.
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Table 3 Grading for subject diary data
Category
None
Tolerable
Affects daily activities
Disabling
7.2.2 Laboratory assessments
For all women of childbearing potential, including those currently using contraception, a urine pregnancy 
test will be performed at screening, all treatment visits (prior to treatment) and at the final study visit at 
Month 12. The test result must be negative for the subject to receive any treatment with study product and 
will be documented in source data and the eCRF.
7.2.3 Pain assessment 
Subjects will rate their pain using an 
 (Appendix 1) where 0 is no pain and 10 is the worst pain 
imaginable. Pain will be assessed immediately after treatment and 30 minutes after treatment at the initial 
treatment visit and at all follow-up visits.
7.2.4 Device palpability
Device palpability will be assessed at each scheduled visit post-treatment by a qualified staff member and 
will assess whether the palpability is the normal expected feel. An unexpected feel is to be recorded as an 
AE.
7.2.5 Adverse events
7.2.5.1 Definition of an adverse event (AE) (Medical Devices Regulation (MDR) article 2(57))
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other personsI, in the context of a clinical 
investigation, whether or not related to the Investigational device. 
This definition includes:
a)
events related to the investigational product or the reference product
b) events related to the procedures involved
c)
events that are anticipated as well as unanticipated
7.2.5.2 Definition of a serious adverse event (SAE) (MDR article 2(58))
An SAE is any AE that:
a)
led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
1. a life-threatening1II illness or injury, or
                                                     
I For users or other persons, this definition is restricted to events related to the investigational product.
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2. a permanent impairment of a body structure or body function, or
3. hospitalisation or prolonged hospitalizationIII, or
4. medical or surgical intervention to prevent life-threatening illness or injury or permanent
impairment to a body structure or a body function,
5. chronic disease
c)
led to foetal distress, foetal death, or a congenital physical or mental impairment or birth defect
In cases of doubt, whether an AE fulfils a serious criterion or not, there should be a predisposition to report 
as a SAE rather than not report as such (see Section 7.2.5.5).
7.2.5.3 Recording instructions for adverse events
Each subject should be questioned about AEs at each study visit following the screening visit. All AEs, 
non-serious as well as serious, are to be reported as an AE in the eCRF.
The question asked should be: ”Since your last clinical visit; have you had any health problems?”. 
Information on AEs can also be obtained from signs and symptoms detected during each examination or 
from a laboratory test, observations made by the study center personnel, subject diaries, or spontaneous 
reports from the subjects or their relatives.
When an AE is related to a device deficiency (refer to Section 7.2.10), including technical device 
malfunction, the AE shall be recorded on the AE form/module in the eCRF and the technical complaint
shall be reported separately on the clinical study complaint form, provided in the investigator file, and in the
eCRF. 
Investigators, or other study center personnel, shall record all AEs in the eCRF, including:
a)
Event term (recorded in standard medical terminology and avoiding abbreviations)
b) Affected area
c)
Start date (first day with symptoms)
d) Stop date (last day with symptoms)
e)
Intensity (mild, moderate, or severe according to definition in Section 7.2.5.4)
f)
Seriousness (serious or not serious, according to definition in Section 7.2.5.2)
g)
Causal relationship to study product or study product injection procedure (yes or no)
h) Action
taken 
(none, 
medication 
treatment, 
non-pharmacological 
treatment,
or
other
procedures/tests, subject withdrawn)
i)
Outcome of the AE (ongoing, recovered, recovered with sequelae, death, chronic/ stable, not 
recovered at the end of the study)
The AE form/module in the eCRF must be signed and dated by the Investigator.
                                                                                                                                                                             
II The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more 
severe. (Source: ICH-E2A clinical safety data management: definitions and standards for expedited reporting).
III Planned hospitalization for a pre-existing condition, or a procedure required by the CSP, without serious 
deterioration in health, is not considered a SAE. (Source: ISO14155:2011).
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The pre-defined, expected post-treatment events shall be assessed separately, see Section 7.2.1. These 
events shall be collected daily by subjects in a diary for 28 days following each treatment.
7.2.5.3.1
Intensity
All AEs, non-serious as well as serious, are to be reported as an AE in the eCRF.
Intensity will be recorded for each reported AE. The following definitions of intensity are to be used:
Mild:
Awareness of symptoms or signs, but easily tolerated (acceptable)
Moderate:
Enough discomfort to interfere with usual activity (disturbing)
Severe:
Incapacity to work or to do usual activity (unacceptable)
If the intensity changes within one day, the maximum intensity of the AE during that day shall be recorded.
7.2.5.3.2
Causal relationship and seriousness
Each AE, serious as well as non-serious, shall be assessed by the Investigator for causal relationship with 
the study product and its use (the injection procedure) and for seriousness (Yes or No) of the event.
A two-point scale (Yes or No response) shall be used for the causality assessments. The 
Investigators shall be asked to indicate a response to each of the following questions in the eCRF:

“Do you consider that there is a reasonable possibility that the event may have been caused 
by the study product?”, and 

“Do you consider that there is a reasonable possibility that the event may have been caused 
by the study product injection procedure?”
If any of these questions is answered Yes, the AE is considered related.
Each AE will also be assessed for causal relationship and seriousness by the Sponsor, in order to 
fulfil regulatory requirements. 
In addition, each SAE will be classified by both the Investigator and Sponsor separately, according to four 
different levels of causality:
1.
Not related - Relationship to the device, comparator or procedures can be excluded when:

the event has no temporal relationship with the use of the investigational device, or the 
procedures related to investigational device;

the serious adverse event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible;

the discontinuation of medical device application or the reduction of the level of activation/ 
exposure - when clinically feasible - and reintroduction of its use (or increase of the level of 
activation/exposure), do not impact on the serious adverse event;

the event involves a body-site or an organ that cannot be affected by the device or procedure;

the serious adverse event can be attributed to another cause (e.g. an underlying or concurrent 
illness/ clinical condition, an effect of another device, drug, treatment or other risk factors);

the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable;
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In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event.
2.
Possible - The relationship with the use of the investigational device or comparator, or the
relationship with procedures, is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect of another 
device, drug or treatment). Cases where relatedness cannot be assessed, or no information has been 
obtained should also be classified as possible.
3.
Probable - The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably explained by 
another cause.
4.
Causal relationship - the serious adverse event is associated with the investigational device, 
comparator or with procedures beyond reasonable doubt when:

the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;

the event has a temporal relationship with investigational device use/application or procedures;

the event involves a body-site or organ that
othe investigational device or procedures are applied to;
othe investigational device or procedures have an effect on;

the serious adverse event follows a known response pattern to the medical device (if the 
response pattern is previously known);

the discontinuation of medical device application (or reduction of the level of activation/ 
exposure) and reintroduction of its use (or increase of the level of activation/exposure), impact 
on the serious adverse event (when clinically feasible);

other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out;

harm to the subject is due to error in use;

the event depends on a false result given by the investigational device used for diagnosis, when 
applicable;
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious adverse event.
7.2.5.4 Reporting of adverse events
AE reporting on each subject shall start upon first treatment. All other events that occur after the subject 
signs the ICF but before enrollment will be recorded in the subject’s medical history. The reporting shall 
continue during each follow-up visit (including telephone contacts and extra visits between planned visits)
until the last scheduled visit in the study.
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7.2.5.5 Reporting of serious adverse events
The Investigator shall report any SAE to the Contract Research Organization (CRO) immediately but not 
later than 24 hours of awareness of the event. This initial report can be made via e-mail or submitted via 
the eCRF. 
In case of difficulty to obtain all the required information within 24 hours, an initial report can be 
submitted, with the following information as a minimum, irrespective of whether some of it is regarded as 
preliminary:

CTN 43CASA2006

Subject identification (age, gender, subject number)

Date when AE occurred

Date when AE became serious

Adverse event description

Name of Investigator and original reporter (if other than Investigator)

Name of study product 

Treatment specification
Follow-up information and data missing in the initial SAE reporting shall be gathered as soon as possible 
and reported to the CRO immediately, but not later than 24 hours of awareness of the new data. Complete 
and adequate information on each SAE is required. All attempts to obtain this information, including dates 
for follow-up activities, must be documented by the Investigator.
Supporting documentation to be provided with the SAE report:

Concomitant therapies form/list

AE form/list

Medical history form/list

Any other relevant supporting documentation (e.g. hospital notes, death certificate, autopsy reports etc.)
___________________________________________________________________________
___________________________________________________________________________
The SAE form must be signed and dated by the Investigator. If the initial 24-hour SAE report does not
contain full information or if it is made without using the SAE form the fully completed and signed SAE
form shall be e-mailed to the CRO. A copy of the fully completed SAE form shall be kept at the study 
center.
In addition, the PI shall report SAEs to RA within 72 hours of discovery and report SAEs to the 
responsible REB without undue delay. The PI is responsible for checking what reporting procedures are 
applicable for his/her REB regarding SAEs and final report of the outcome of the study and to comply with 
such reporting procedures during the study period.
The Sponsor is responsible for reporting to the RA according to national regulations.
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Enrollment and injections at a study center will be temporarily halted if an SAE occurs for a vascular 
embolic event that leads to skin necrosis, vision loss, or stroke and is determined by the Investigator to be 
directly or possibly related to the investigational device or injection procedure, see stopping rules in section
4.1.
Following the initial SAE report from the Investigator to the CRO, the sponsor shall conduct an evaluation 
of the SAE and report the results of such evaluation to RA and to all reviewing ECs and participating 
investigators within 10 working days after the Sponsor first receives notice of the effect. Thereafter the 
Sponsor shall submit such additional reports concerning the effect as RA requests.
7.2.6 Follow-up of unresolved events ongoing at termination of the study
All serious as well as non-serious AEs with a causal relationship to the study product or treatment
procedure and ongoing at study end, shall be followed up after the subject's participation in the study is 
over. Such events shall be followed-up after the last study visit until resolved, assessed as chronic or stable, 
or subject is lost to follow up. Follow-up information shall be reported on the AE follow-up form.
7.2.7 Follow-up of events occurring after subject termination of the study
All AEs with a causal relationship to the study products or treatment procedure that the Investigator 
becomes aware of, serious as well as non-serious, with onset after the study termination (subject’s last study 
visit) shall be reported to the Sponsor. The report should as a minimum include the information described in 
Section 7.2.5.3. The report can be sent via e-mail according to contact details specified in Section 7.2.5.5. 
The events shall thereafter be followed-up until resolved, considered chronic or stable, or subject is lost to 
follow up.
7.2.8 Anticipated adverse events
Information regarding anticipated AEs for Sculptra is included in the study specific IFU.
7.2.9 Pregnancy
Pregnancy itself is not regarded as an AE.
If there is a pregnancy during the study period, the subject must be withdrawn from any following study 
treatment but should continue to be followed within the study and the outcome of pregnancy must be 
reported even if the delivery occurs after study completion.
A pregnancy confirmed during the study period must be reported by the Investigator on a pregnancy report 
form immediately upon acknowledge and be submitted to the CRO according to contact details specified in 
section 7.2.5.5. The report can be prospective or retrospective. Follow-up shall be conducted to obtain 
outcome information on all prospective reports. 
Cases that led to fetal distress, fetal death or a congenital abnormality or birth defect are to be regarded as
SAEs and shall be reported on the exposure in utero report form to the Sponsor immediately but no later 
than 24 hours after the Investigators awareness. These events shall be handled as SAEs during data 
processing. Other complications during the pregnancy that are related to the pregnant woman and fulfils 
any serious criteria, such as pre-eclampsia requiring hospitalization, shall be reported and handled as SAEs. 
Elective abortions without complications shall not be reported as AEs.
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7.2.10 Device deficiencies
7.2.10.1 Definition of a device deficiency
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety2, or performance.
Note: Device deficiencies include malfunctions, use errors, and inadequate labelling.
7.2.10.2 Recording instructions for device deficiencies
In the event of a device deficiency. the Investigator shall send the completed clinical study complaint form 
to the CRO.
A device deficiency that led to a SAE and any device deficiency that could have led to a SAE shall be 
reported to the CRO within 72 hours after the Investigator’s awareness (for contact information, see 
section 7.2.5.5). If the form is completed within an eCRF system, refer to the eCRF completion guidelines.
If the Investigator or the Sponsor assesses that the device deficiency could have led to a SAE the Sponsor is 
responsible for reporting the device deficiency to RA and the PI is responsible for reporting it to the REB.
The deficient study product shall be kept by the study center until the Sponsor has confirmed whether the
product shall be returned to Sponsor for further study or if it can be destroyed at the study center.
7.2.11Stopping rule
Enrollment and injections at a study center will be temporarily halted if an SAE occurs for a vascular 
embolic event that leads to skin necrosis, vision loss, or stroke and is determined by the Investigator to be 
directly or possibly related to the investigational device or injection procedure. 
The SAE will be investigated by the Sponsor. If the Sponsor’s investigation concludes the SAE:

was unanticipated

directly related to the study product or device injection procedure and

presents an unreasonable risk to study subjects, 
the study will be terminated, and the Investigators notified. The REB and RA will also be notified if the 
study is prematurely terminated due to safety concerns.
If the SAE does not meet the above criteria, then enrollment in the study will continue provided all other 
safety criteria have been met.
8.
STATISTICAL DESIGN AND ANALYSIS
8.1
General
All statistical analyses, including summary tables and data listings, will be performed using the SAS®
system. Confidence intervals and p-values will be 2-sided and performed at a significance level of 5%.
                                                     
2 Inadequacy of device safety refers to properties of the device which could have or have led to an AE.
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8.5.2 Secondary analysis
The GAIS assessment by the Treating Investigator will be presented in frequency tables. In addition, the 
proportion of improved thighs (assessed as at least improved) will be presented together with a 95% 
confidence interval (based on the binomial distribution). This will be done for each thigh separately and 
also for both thighs combined at Month 1, 2, 6, 9 and 12.
The GAIS assessment by the subject will be presented in frequency tables. In addition, the proportion of 
improved thighs (assessed as at least improved) will be presented together with a 95% confidence interval 
(based on the binomial distribution). This will be done for each thigh separately and also for both thighs 
combined at Month 1, 2, 6, 9 and 12.
8.6
Safety analysis
AEs will be coded according to MedDRA and summarized by system organ class (SOC), preferred term 
(PT). The number of subjects with AEs related to study product or injection procedure as well as the 
number of events will be summarized by SOC, PT, and maximum intensity. In addition, for related AEs the 
number of days to onset and the duration of event will be summarized by SOC and PT using mean, SD,
min, max and median. Action taken for related AEs will also be summarized. Serious AEs will be listed.
Non-related AEs will be summarized by SOC, PT, and maximum intensity.
Number and percentage of subjects reporting each pre-defined, expected, post-treatment symptoms, as 
collected in the 28 days diary, will be presented in total and by maximum severity for each treatment 
session.
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8.7
Handling of missing data
Study data will be presented on observed cases, i.e.no imputation of missing values will be performed. 
Exception: when calculating duration and time to onset for AEs where start date is missing. If the start date 
is missing, it will be assumed that the AE started on the day of most recent treatment.
8.8
Interim analysis
No applicable as this is an open study.
8.9
Data monitoring committee
Not applicable. 
8.10
Withdrawals and deviations
All withdrawn subjects will be listed individually, including at least subject number, date and reason for 
withdrawal, and last visit performed.
Subjects with CSP deviations will be listed individually, including subject number and observed deviation. 
Depending on the seriousness of the deviation, subject might be excluded from the PP population, which 
shall be documented prior to database lock.
Deviations from the statistical plan will be documented in the clinical report.
8.11
Sample size
The sample size of approximately 30 subjects is not based on a statistical calculation. The selected number 
of subjects is regarded as enough for an evaluation of safety and effectiveness in this pilot study.
9.
DATA MANAGEMENT
Data management based on GCP refers to the activities defined to achieve safe routines to enter clinical 
data information into a database, efficiently and avoiding errors. The data management routine includes
procedures for database set-up and management, data entry and verification, data validation, and 
documentation of the performed activities including information of discrepancies in the process. The data 
management process will be described in detail in the data management plan (DMP).
The database, the data entry screens and program will be designed in accordance with the CSP and the CRF
template. Data validation will be performed by computerized logical checks and manual review. Drugs and 
events will be coded in accordance with World Health Organization (WHO) Drug and medical dictionary 
for regulatory activities (MedDRA) dictionaries as specified in the DMP. Safety data (SAE and if 
applicable AE of special interest) in the clinical database will be reconciled against the data in the safety 
database.
When all efforts have been made to ensure that the data recorded in the eCRFs and entered in the database 
is as correct and complete as possible, the clinical database will be locked. Study data will be transferred to 
SAS datasets, which thereafter will be write-protected. Statistical analyses will be generated in SAS using 
data from the locked datasets.
9.1
Protection of personal data
The study shall include collection and processing of personal data as specified in the Regulation European 
Union (EU) 2016/679 (General Data Protection Regulation, GDPR) and the regulation EU 2017/745 
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(MDR) on the protection of individuals with regard to the processing of personal data and on the free 
movement of such data, the Personal Information Protection and Electronic Documents Act (PIPEDA) in 
Canada. For the purposes of the study, Sponsor will be considered the data controller, and Institution and PI
will both be considered data processors.
All processing of personal data must be carried out in accordance with national legislation concerning the 
protection of personal data. The Institution and the Investigator are responsible for complying with all 
requirements pursuant to national legislation in which the Institution and the Investigator are located. The 
Sponsor will ensure that all requirements for data processing are fulfilled.
The ICF shall contain information about what personal data to be collected in the study and that this will be
kept confidential. The provided information shall be sufficient to enable all subjects to give their consent 
not only to the participation in the study, but also to the processing of personal data. Such information 
includes information regarding the purposes of the collecting, processing, data transfer to countries not 
having same high level of security for processing of personal data than Sweden and EU, and the length of 
time during which personal data will be stored. The subject shall have the right of access to stored personal 
data, and the right to correction of incorrect information. 
If a subject decides to terminate the study prematurely, data collected before withdrawal of consent will be 
used in the evaluation of the study, however no new data may be collected. 
Authorized representatives from the Sponsor, CRO or a RA may visit the study center to perform 
audits/inspections, including source data verification, i.e. comparing data in the subjects’ medical records 
and the eCRF. Data and information shall be handled strictly confidential.
9.2
Data Collection
An electronic data capture application, compliant with regulatory requirements for software validation (US
FDA 21CFR11) will be used to collect, modify, maintain, archive, retrieve, and transmit study data. An
eCRF is required and shall be completed electronically for each screened subject (screening visit) and 
enrolled subjects (subsequent visits). 
The eCRF includes password protection and internal quality checks, such as automatic range checks, to 
identify data that appear inconsistent, incomplete, or inaccurate. Study data shall be entered directly from 
the source documents, which are to be defined at each study center before inclusion of the first subject.
Authorized study center personnel designated by the PI shall complete data collection. Appropriate training
and security measures shall be completed with all authorized study center personnel prior to the study being 
initiated and any data being entered into the system for any subject.
The study data is the sole property of the Sponsor and shall not be made available in any form to third 
parties, except for authorized representatives of appropriate RA, without written permission from the 
Sponsor. At the end of the study, electronic data are kept at the Sponsor and a copy (provided by the
vendor) at the study center as part of the Investigator file.
Any delegation of collection of data shall be specified and recorded.
9.2.1 Data entry
All data shall be entered in English. The eCRFs should always reflect the latest observations on the subjects
participating in the study. Therefore, the eCRFs shall be completed as soon as possible during or after the 
subject’s visit. The subject’s identity must always remain confidential, i.e. the name and address of the 
subjects must not be registered in the eCRFs or in the database. The Investigator must verify that all data 
entries in the eCRFs are accurate and correct. If some assessments are not done, or if certain information is 
not available, not applicable or unknown, the Investigator shall indicate this in the eCRF. The Investigator 
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shall electronically sign off the study data. By signing, the Investigator takes responsibility for the accuracy, 
completeness, and legibility of the data reported to the Sponsor in the eCRF.
9.2.2 The query process
The monitor shall review the eCRFs and evaluate them for completeness and consistency. Each eCRF shall 
be compared with the respective source documents to ensure that there are no discrepancies between critical 
data. All entries, corrections, and alterations shall be made by the PI or his/her authorized designee. The 
monitor cannot enter data in the eCRFs. Once study data have been submitted to the central server via the 
eCRF, corrections to the data fields will be audit trailed, meaning that the reason for change, the name of
the person who made the change, together with time and date will be logged. Roles and rights of the study 
center personnel responsible for entering study data into the eCRF shall be determined in advance. If 
discrepant data is detected during review of the data, either by the Sponsor or by its representatives, the 
responsible data manager or monitor shall raise a query in the electronic data capture application. The query 
shall state the question or data to be changed and shall be resolved in the system by the PI or his/her
authorized designee. The appropriate study center personnel shall answer the queries in the eCRF. This will 
be audit trailed by the electronic data capture application meaning that the name of study center personnel, 
time, and date is logged.
9.2.3 User identification
Electronic CRF records will be automatically appended with the identification of the creator, by means of 
their unique UserID. Specified records shall be electronically signed by the Investigator to document his/her 
review of the data and acknowledgement that the data are accurate. This will be facilitated by means of the
Investigator’s unique UserID and password; date and time stamps will be added automatically at time of 
electronic signature. If an entry in an eCRF requires change, the correction shall be made in accordance 
with the relevant software procedures. 
9.2.4 Audit trail
All changes will be fully recorded in a protected audit trail and a reason for the change shall be stated. Once
all data have been entered, verified, and validated, the database will be locked.
9.2.5 Source documentation
Source documents are all documents used by the Investigator or hospital that relate to the subject’s medical 
history, that verifies the existence of the subject, the inclusion and exclusion criteria, and all records 
covering the subject’s participation in the study. They include laboratory notes, memoranda, material 
dispensing records, subject files, etc.
The Investigator is responsible for maintaining adequate and accurate source documents. Source data 
should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data 
should be traceable, should not obscure the original entry and should be explained if necessary.
Source documents shall be made available for inspection by the monitor at each monitoring visit. The 
Investigator must submit a completed eCRF for each subject for whom signed informed consent has been 
collected. All supportive documentation submitted with the eCRF, such as laboratory or hospital records, 
shall be clearly identified with the CTN and subject number. Any personal information, including name, 
shall be removed or rendered illegible to preserve individual confidentiality.
The PI/Institution shall permit study-related monitoring, audits, REB review, and RA inspections and shall 
provide direct access to the source data/medical record including the identity of all participating subjects 
(sufficient information to link records, i.e. eCRF, medical records, original signed ICFs and detailed records 
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of study product accountability). The records shall be retained by the PI as required by local legislation and 
international guidelines. Any transfer of responsibility for storage of the records shall be documented and 
the Sponsor shall be informed in writing.
The Sponsor shall verify that each subject has consented in writing to direct access to the original medical 
record/source data (by the use of written subject information and signed informed consent). The data 
recorded in the eCRFs will be checked for consistency with the source documents/medical record by the 
monitor during monitoring (source data verification; SDV). In order to be able to perform SDV, 
information about each subject’s participation in the study has to be detailed in the medical record or other 
relevant source. 
9.3
Archiving / Record keeping
All records pertaining to the conduct of the study, including signed eCRFs, ICFs, study product 
accountability records, source documents, and other study documentation must be retained for as long as is 
specified in the CTA after study completion or longer if required by national legislation. Sponsor will 
inform the study centers as to when these documents no longer needs to be retained. Measures shall be 
taken to prevent accidental or premature destruction of these documents (e.g. protection against damage and 
unauthorized access, preferably by storage in a fireproof cabinet).
After study completion and database lock, electronic study data shall be provided by the CRO for archiving.
It is the PI’s responsibility to inform the Sponsor in writing if the Investigator file is moved or if the 
responsibility for the documents is transferred to someone else.
10. PROTOCOL DEVIATIONS
The PI is not allowed to deviate from the CSP. However, under emergency circumstances, deviations from 
the CSP to protect the rights, safety and well-being of the subjects may proceed without prior approval of 
the Sponsor and the REB and RA. Such deviations should be documented and reported to the REB and RA
as soon as possible. Deviations will be reviewed to determine the need to amend the CSP or to terminate the 
study. The PI is responsible for promptly reporting any deviations from the CSP that affects the rights, 
safety or well-being of the subject or the scientific integrity of the study, including those which occur under 
emergency circumstances, to the Sponsor (within 24 hours following detection) as well as the REB if 
required.
11. QUALITY CONTROL AND QUALITY ASSURANCE
11.1
Personnel Training
The product is reserved for use by the PI or his/her authorized designee in accordance with local legislation, 
trained in the appropriate aseptic injection techniques and expected to follow the recommendations in the 
study specific IFU. Additional training on the reconstitution procedure and treatment in the posterior thigh 
area will be provided by the Sponsor. 
11.2
Quality Control / Clinical Monitoring
Study center monitoring of the study will be arranged by the Sponsor according to GCP guidelines to verify 
that the rights and well-being of the subjects are protected, the reported data are accurate, complete,
verifiable from source documents, and that the conduct of the study complies with the approved CSP, 
subsequent amendment(s), GCP and the applicable regulatory requirements.
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Any CSP deviation shall be documented appropriately, verified, discussed, and collected by the monitor
and appropriate actions will be taken. The PI is responsible for promptly reporting any deviations from the 
CSP that affects the rights, safety or well-being of the subject or the scientific integrity of the study, 
including those that occur under emergency circumstances, to the Sponsor as well as the REB if required by 
national regulations. Deviations will be reviewed to determine the need to amend the CSP or to terminate 
the study.
11.3
Quality assurance / Audit / Inspections
The study center may be subject to quality assurance audit by the Sponsor as well as inspection by 
appropriate RA. It is important that the PI and other relevant study center personnel are available during the 
monitoring visits, possible audits, and inspections, and that sufficient time is devoted to the monitoring 
process.
Each participating member of the study center team shall provide a curriculum vitae (CV) or equivalent that
demonstrates their qualifications to conduct the study.
It is the responsibility of the PI to ensure that all personnel involved in the study are fully informed of all 
relevant aspects of the study, including detailed knowledge of and training in all procedures to be followed.
All Investigators and other responsible persons shall be listed together with their function in the study on 
the signature and delegation log.
12. ETHICS
The clinical investigation shall not commence until written approval/favorable opinion from the REB and, 
if required, the relevant RA of the countries where the clinical investigation is taking place has been 
received.
12.1
Application to Research Ethics Board and Regulatory Authority
It is the responsibility of the Principal Investigator (PI) to obtain approval of the CSP/CSP amendment(s)
from the REB The study shall not begin until the required favorable opinion from the REB has been 
obtained. The PI shall file all correspondence with the REB in the Investigator file and copies of REB
approvals shall be forwarded to the Sponsor. Any additional requirements imposed by the REB or RA shall 
be followed. 
The study requires application for approval from the RA. The study will not be started until the Sponsor has 
received written approval or until the statutory waiting period from the appropriate authority has elapsed. 
The Sponsor will provide the PI with a copy of the relevant document.
The collection, access to, processing, and transfer of protected health information or sensitive personal data 
shall be carried out in accordance with applicable rules and regulations.
12.2
Subject information and consent
The PI or his/her authorized designee must always use the REB-approved subject information and ICF and 
it must not be changed without prior discussion with the Sponsor and approval from the applicable REB.
It is the responsibility of the PI or his/her authorized designee to give each subject prior to inclusion in the 
study, full and adequate verbal and written information regarding all aspects of the clinical study that are 
relevant to the subject’s decision to participate throughout the study, e.g. explain the purpose and 
procedures of the study, the duration and number of expected participants, possible risks involved, and the 
opinion of the REB. The subject shall be informed that the participation is confidential and voluntary and 
that the subject has the right to withdraw from the study at any time, without any consequences to his/her 
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future medical care, treatment or benefits to which the subject is otherwise entitled. The information shall 
be provided in a language clearly and fully understandable to the subject. The subject shall be given
sufficient time to read and understand the ICF and to consider participation in the study. Before any study-
related activities are performed, the ICF shall be personally signed and dated by the subject and the PI or 
his/her authorized designee responsible for conducting the informed consent process. The consent includes
information that data will be collected, recorded, processed, and may be transferred to other countries. The 
data will not contain any information that can be used to identify any subject.
Photographs collected during the study will be analyzed and stored in a database by the Sponsor and its
representatives in order to evaluate the effect of the treatment in the study. 
All signed ICFs shall be filed in the Investigator file. The subject shall be provided with a copy of the 
signed and dated ICF and any other written information.
The Investigator shall ensure that important new information is provided to new and existing subjects 
throughout the study.
13. FINANCING, INDEMNIFICATION AND INSURANCE
The CTA outlines the compensation and payment terms of the study. The CTA must be signed before the 
first subject is screened in the study. If there are differences between the CTA and the CSP regarding
certain rights and obligations, the CTA is the prevailing document. Q-Med AB’s obligations in this clinical 
study are covered by Galderma’s global general liability program. An insurance certificate will be provided 
upon request. The Institution/PI is obligated to maintain insurance coverage for their obligations in the 
clinical study according to the CTA.
14. SUSPENSION OR PREMATURE TERMINATION
The Sponsor will suspend or terminate the study when so instructed by the REB or RA, or if it is judged 
that the subjects are subjected to unreasonable risks, or for valid scientific or administrative reasons, or for 
business reasons.
15. PUBLICATION POLICY
The PI’s, Institution’s, and Q-Med AB’s obligations regarding intellectual property rights, confidentiality, 
and publications are described in detail in the CTA.
The aim is to submit the results of this study for publication in the public database ClinicalTrials.gov and to 
a medical journal for a first joint publication of the results. Everyone who is to be listed as an author of the 
results of this multicenter study shall have made a substantial, direct, intellectual contribution to the work. 
Authorship will be based on (1) substantial contributions to the conception or design of the work; or the 
acquisition, analysis, or interpretation of data for the work; and (2) drafting the work or revising it critically 
for important intellectual content; and (3) final approval of the version to be published; and (4) agreement 
to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of 
any part of the work are appropriately investigated and resolved3. Conditions 1, 2, 3, and 4 must all be met
in order to be designated as author. Those who do not meet all four criteria will be acknowledged. Among 
                                                     
3 Defining the role of authors and contributors, compiled by the International Committee of Medical Journal Editors 
(ICMJE) (http://www.icmje.org).
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the authors that fulfil the above-mentioned criteria, one author will be appointed by Q-Med AB to take
primary responsibility for the overall work as primary author.
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16. REFERENCES
1.
Luebberding S, Krueger N, Sadick NS. Cellulite: an evidence-based review. Am J Clin 
Dermatol. Aug 2015;16(4):243-256. doi:10.1007/s40257-015-0129-5
2.
Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. 
Dermatologic Surgery: Official Publication for American Society for Dermatologic 
Surgery [et Al]. 2020-10 2020;46 Suppl 1:S77-S85. doi:10.1097/DSS.0000000000002388
3.
Alexiades M, Munavalli G, Goldberg D, Berube D. Prospective Multicenter Clinical Trial 
of a Temperature-Controlled Subcutaneous Microneedle Fractional Bipolar 
Radiofrequency System for the Treatment of Cellulite. Dermatologic Surgery: Official 
Publication for American Society for Dermatologic Surgery [et Al]. 2018-10 
2018;44(10):1262-1271. doi:10.1097/DSS.0000000000001593
4.
Casabona G, Pereira G. Microfocused Ultrasound with Visualization and Calcium 
Hydroxylapatite for Improving Skin Laxity and Cellulite Appearance. Plast Reconstr Surg 
Glob Open. Jul 2017;5(7):e1388. doi:10.1097/GOX.0000000000001388
5.
Brauer JA, Christman MP, Bae YSC, et al. Three-Dimensional Analysis of Minimally 
Invasive Vacuum-Assisted Subcision Treatment of Cellulite. 2018 2018;17(9):6. 
6.
Canela VC, Crivelaro CN, Ferla LZ, et al. Synergistic effects of Combined Therapy: 
nonfocused ultrasound plus Aussie current for noninvasive body contouring. Clinical, 
Cosmetic and Investigational Dermatology. 2018 2018;11:203-212. 
doi:10.2147/CCID.S157782
7.
Turlier V, Delalleau A, Casas C, et al. Association between collagen production and 
mechanical stretching in dermal extracellular matrix: in vivo effect of cross-linked 
hyaluronic acid filler. A randomised, placebo-controlled study. J Dermatol Sci. Mar 
2013;69(3):187-94. doi:10.1016/j.jdermsci.2012.12.006
8.
Hexsel D, Hexsel C. The role of skin tightening in improving cellulite. Dermatol Surg. Dec 
2014;40 Suppl 12:S180-3. doi:10.1097/DSS.0000000000000204
9.
Guida S, Bovani B, Canta Pier L, et al. Multicenter study of vacuum-assisted precise tissue 
release for the treatment of cellulite in a cohort of 112 Italian women assessed with cellulite 
dimples scale at rest. Journal of Cosmetic and Laser Therapy: Official Publication of the 
European Society for Laser Dermatology. 2019 2019;21(7-8):404-407. 
doi:10.1080/14764172.2019.1683209
10.
Eldsouky F, Ebrahim HM. Evaluation and efficacy of carbon dioxide therapy 
(carboxytherapy) versus mesolipolysis in the treatment of cellulite. Journal of Cosmetic 
and Laser Therapy: Official Publication of the European Society for Laser Dermatology. 
2018-10 2018;20(5):307-312. doi:10.1080/14764172.2017.1400175
11.
Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clinical, 
Cosmetic and Investigational Dermatology. 2017 2017;10:17-23. 
doi:10.2147/CCID.S95830
12.
Ibrahim O, Haimovic A, Lee N, Kaminer MS. Efficacy Using a Modified Technique for 
Tissue Stabilized-Guided Subcision for the Treatment of Mild-to-Moderate Cellulite of the 
Buttocks and Thighs. Dermatologic Surgery: Official Publication for American Society for 
Dermatologic Surgery [et Al]. 2018-10 2018;44(10):1272-1277. 
doi:10.1097/DSS.0000000000001542
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13.
Nikolis A, Enright KM, Sapra S, Khanna J. A Multicenter, Retrospective Evaluation of 
Tissue Stabilized-Guided Subcision in the Management of Cellulite. Aesthetic Surgery 
Journal. 2019-07-12 2019;39(8):884-892. doi:10.1093/asj/sjy274
14.
Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of 
human tissue response to injectable poly-L-lactic acid. Dermatol Surg. Jun 2013;39(6):915-
22. doi:10.1111/dsu.12164
15.
Jones DH, Fitzgerald R, Cox SE, et al. Preventing and Treating Adverse Events of 
Injectable Fillers: Evidence-Based Recommendations From the American Society for 
Dermatologic Surgery Multidisciplinary Task Force. Dermatol Surg. Feb 2021;47(2):214-
226. doi:10.1097/DSS.0000000000002921
16.
MA-38911. PLLA Intravascular Injection Treatment Protocol.
17.
Vleggaar D, Fitzgerald R, Lorenc ZP, et al. Consensus recommendations on the use of 
injectable poly-L-lactic acid for facial and nonfacial volumization. Journal of drugs in 
dermatology: JDD. Apr 2014 2014;13(4 Suppl):s44-51. 
18.
The Fitzpatrick Classification Scale for Skin Types      
https://www.verywell.com/fitzpatrick-classification-scale-1069226. 
19.
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch 
Dermatol. Jun 1988;124(6):869-71. doi:10.1001/archderm.124.6.869
20.
Christensen LH. Host tissue interaction, fate, and risks of degradable and nondegradable 
gel fillers. Dermatol Surg. Oct 2009;35 Suppl 2:1612-9. doi:10.1111/j.1524-
4725.2009.01338.x
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SIGNED AGREEMENT OF THE CLINICAL STUDY PROTOCOL
CTN:
43CASA2006
Title of the CSP:
A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic acid 
(PLLA) for the Improvement in Appearance of Cellulite.
I, the undersigned, have read and understand the Clinical Study Protocol (CSP) specified above, and agree 
on the contents. The CSP, the Clinical Trial Agreement (CTA) and the additional information given in the
Investigator’s brochure (IB) and the study specific Instructions for Use (IFU) will serve as a basis for co-
operation in this study.
Principal Investigator
Printed name 
Signature
Date
Study center
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Sign page:1 of 1
SIGNATURES PAGE
Date
Signed by
2021-06-17 21:51
Justification
Compiled by
2021-06-18 05:51
Justification
Approved by Technical Expert
2021-06-18 09:57
Justification
Approved by Owner
2021-06-21 06:13
Justification
Approved by Technical Expert
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PPD
PPD
PPD
PPD