A Prospective Open-label Study to Evaluate Safety and Effectiveness of Two Different Reconstitution Volumes of Poly-l-lactic Acid (PLLA) for Correction of Wrinkles in the décolletage Area
Phase: NA
Conditions: Wrinkles in Decolletage
Sponsor: Galderma R&D

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CLINICAL INVESTIGATIONAL PLAN
PROTOCOL NUMBER: 43USSA2112
This document contains confidential, proprietary information
This clinical study protocol contains confidential information belonging to Q-Med AB, part of the Galderma 
Group. Q-Med AB is the owner of all information included in this Clinical Study Protocol as Sponsor and then 
Sponsor reserves all proprietary rights. No information may be disclosed to any third party (except where 
required by applicable law) without prior written consent from Q-Med AB.
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A prospective open-label study to evaluate safety and effectiveness of two 
different reconstitution volumes of poly-l-lactic acid (PLLA) for correction 
of wrinkles in the décolletage area
Clinical Trial Number (CTN):  
43USSA2112
Study Device: 
Sculptra
SPONSOR: 
Galderma Research & Development, LLC
14501 North Freeway
Fort Worth, TX 76177
Q-Med AB, part of the Galderma Group
Seminariegatan 21
SE-752 28 Uppsala, Sweden
Telephone: 
+46 18 474 90 00
Fax: 
+46 18 474 90 91
The study should be conducted in compliance with the clinical trial agreement, the clinical investigational plan
(CIP), 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 Harmonisation (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 Helsinki (1).
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INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
Further details on all participating Investigators and the complete administrative structure of 
the study are found in the study files. Note that administrative changes are to be documented 
in the study files without requiring a CIP amendment.
Sponsor:
Galderma Research & Development, 
LLC
14501 North Freeway
Fort Worth, TX 76177
Q-Med AB
Seminariegatan 21
SE-752 28 Uppsala 
Sweden
Telephone: +46 (0)18 474 90 00
:
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SYNOPSIS
Clinical Study Title:
A prospective open-label study to evaluate safety and effectiveness of 
two different reconstitution volumes of poly-l-lactic acid (PLLA) for 
correction of wrinkles in the décolletage area
Clinical Trial Number:
43USSA2112
Country Involved and 
Planned Number of Study 
Centers:
Country: USA
No. of Study Centers: 2
Clinical Study Design:
This is a prospective open-label study to evaluate safety and 
effectiveness of two different reconstitution volumes of poly-l-lactic 
acid (PLLA) for correction of wrinkles in the décolletage area.
Approximately 30 adult female subjects will be enrolled in the study 
and randomized 1:1 to receive either Sculptra reconstituted with 8 mL 
Sterile Water For Injection (SWFI) with the addition of 1 mL 2% 
lidocaine hydrochloride (HCl), or Sculptra reconstituted with 17 mL 
SWFI with the addition of 1 mL 2% lidocaine HCl. Subjects will be 
stratified by Galderma Décolletage Scale (GDS) severity score 
(moderate or severe) and by study center. 
Eligible subjects will be offered treatment with Sculptra in four 
sessions spaced one month (+2 weeks) apart. Safety and effectiveness 
data will be collected for up to 9 months following the initial 
treatment. 
The study visits are illustrated in the Clinical study flowchart. 
Assessments are outlined in the Schedule of Assessments and 
summarized in Sections 6 and 7.
Effectiveness assessments include: 

Photography 

Grading of wrinkles in the décolletage area by the 
Treating Investigator using the GDS 

Global 
aesthetic 
improvement 
by 
the 
Treating 
Investigator and Subject using Global Aesthetic 
Improvement Scale (GAIS).  
Safety assessments include: 

An evaluation and an interview of the subjects at each 
visit to obtain information about any medical occurrence 
that meets the definition of an AE

Subject diary

Laboratory assessment
Indication:
Correction of moderate or severe wrinkles in the décolletage area.
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Total Number of Subjects 
(Planned): 
Approximately 30 adult female subjects will be enrolled.
Primary Effectiveness Objective 
and Endpoint:  
Objective 
To evaluate the effectiveness of Sculptra for correction of wrinkles in 
the décolletage area. 
Endpoint 
Percentage of responders, defined by at least one grade improvement 
from baseline, on the Galderma Décolletage Scale (GDS), as assessed 
live by the Treating Investigator, at Month 9.
Secondary Effectiveness 
Objectives and Endpoints:  
Objective
To evaluate the effectiveness of Sculptra for correction of wrinkles in 
the décolletage area.
Endpoints 
1.
Percentage of responders, defined by at least one grade 
improvement from baseline, on the Galderma Décolletage 
Scale (GDS), as assessed live by the Treating Investigator, at 
Month 6. 
2.
Percentage of responders, defined by having at least 
“Improved” (improved, much improved or very much 
improved) according to the Global Aesthetic Improvement 
Scale (GAIS), as assessed by the subject and the Treating 
Investigator separately, at Month 6 and 9. 
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Safety Objective and Endpoints:
Objective
To evaluate the safety of Sculptra for correction of wrinkles in the 
décolletage area.
Endpoints
1.
Incidence, intensity, time to onset and duration of Adverse 
Events (AEs) collected throughout the study period.
2.
Incidence, intensity and number of days of pre-defined 
expected post-treatment events collected using subject diaries 
for 28 days from each treatment.
Subgroup Analyses:
AEs will be summarized by treatment group injection volume: 8 vs 17 
mL.
Clinical Study Duration:
The planned clinical study duration (from First Subject First Visit to 
Last Subject Last visit) is approximately 13 months (including 3 
months for enrollment).
The planned duration of study participation for each enrolled subject 
is approximately 10 months.
One month is defined as four weeks in the study.
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.
Non-pregnant, non-breastfeeding females, 22 years of age or 
older. 
3.
Subjects seeking treatment for wrinkles in the décolletage. 
4.
Subjects with grade 2 (moderate) or 3 (severe) on the 
Galderma Décolletage Scale (GDS). 
5.
Subjects willing to abstain from any other surgical or 
cosmetic procedures in the décolletage area for the duration 
of the study (e.g., mesotherapy or resurfacing procedure 
(laser, chemical peels or other ablative or non-ablative 
treatment)). 
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Exclusion Criteria:
The presence of any of the following exclusion criteria excludes a 
subject from enrollment in the study:
1.
Known/previous allergy or hypersensitivity to any of the
Sculptra constituents. 
4.
Previous 
tissue 
augmenting 
therapy, 
contouring 
or 
revitalization treatment in the décolletage, with any of the 
following prior to baseline visit: 
8.
Previous treatment/procedure in the treatment area in the 
previous 6 months that would interfere with the study 
injections and/or study assessments, e.g.: 
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Investigational Product:
Sculptra, a sterile, freeze-dried, injectable PLLA available in 367.5 
mg dose vials including 150 mg PLLA. Commercially available 
Sculptra, reconstituted in either 8 mL or 17 mL per vial using SWFI, 
with the addition of 1 mL 2% lidocaine HCl.
Comparator/Placebo Product:
Not applicable.
Treatment area:
Treatment regimen:
Mode of administration:
Each subject will be treated at baseline, and optionally at Month 1, 
Month 2 and Month 3, with a maximum of 2 vials of Sculptra per 
treatment session, i.e. a maximum of 8 vials in total per subject. 
Subjects are randomized to receive Sculptra reconstituted in 8 mL 
SWFI or 17 mL SWFI, with the addition of 1 mL 2% lidocaine HCl
and the study product will be administered with a 25 Gauge (G) thin 
wall needle in an approximately 30-45 degree angle.
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ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event 
AESI
Adverse Event of Special Interest
CFR
Code of Federal Regulations
CIP
Clinical Investigational Plan
CMC
Carboxymethylcellulose
CRO
Contract Research Organization
CTA
Clinical Trial Agreement
CTN
Clinical Trial Number
Device 
deficiency
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance (includes malfunctions, use 
errors, and inadequate labelling)
DBL
Database lock
DMP
Data management plan
eCRF
Electronic Case Report Form
FDA
Food and Drug Administration
FST
Fitzpatrick skin type 
G
Gauge
GAIS
Global Aesthetic Improvement Scale
GCP 
Good Clinical Practice 
GDP
Good Documentation Practice
GDS
Galderma Décolletage Scale
HCl
Hydrochloride
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
IDE
Investigational Device Exemption
IFU
Instructions For Use
Institution
Any public or private entity or agency or medical or dental facility where a 
clinical study is conducted.
Investigational 
product
Medical device being assessed for safety or performance in a study. 
“Investigational product” is the same as “study device”, “investigational 
device”, or” investigational medical device”.
Investigator
The Investigator or other qualified person, i.e. sub-Investigator, designated 
and supervised by the Investigator at a study site to perform critical study-
related procedures or to make important study-related decisions as specified 
on the signature and delegation log
Investigator file
Essential documents relating to a clinical study as defined in applicable GCP 
guidance document and maintained by the Investigator.
IRB
Institutional Review Board
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ISO
International Organization for Standardization
ITT
Intention-to-Treat
IUD
Intra uterine Device
MedDRA
Medical Dictionary for Regulatory Activities
NaCMC
Sodium carboxymethylcellulose
PI
Principal Investigator
PP
Per protocol
PLLA
Poly L- Lactic Acid
PT
Preferred Term
RA
Regulatory authority
ROPI
Report of Prior Investigations
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Standard deviation
SDV
Source Data Verification
SOC
System Organ Class
Sponsor file
Essential documents relating to a clinical study as defined in applicable GCP 
guidance document and maintained by the Sponsor.
Study files
The Investigator file and the Sponsor file
Study product
The investigational product 
Study site
Institution or site where the study is carried out
SWFI
Sterile Water For Injection
USP
United States Pharmacopeia
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TABLE OF CONTENTS
Investigators and Study Administrative Structure.........................................................................3
Synopsis...............................................................................................................................................4
Clinical study flowchart...................................................................................................................11
Schedule of Assessments..................................................................................................................12
Abbreviations and Definitions of Terms........................................................................................13
Table of Contents .............................................................................................................................15
1.
BACKGROUND INFORMATION........................................................................................20
1.1
Medical background, indication and population description
20
1.2
Study Device Profile
21
1.2.1
Non-clinical documentation
22
1.2.2
Clinical documentation
22
1.3
Risks and benefits
22
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESIS..............................................24
2.1
Effectiveness objectives and endpoints
24
2.1.1
Primary effectiveness endpoints
24
2.1.2
Secondary effectiveness endpoints
24
2.2
Safety objectives and endpoints
25
3.
STUDY DESIGN......................................................................................................................25
3.1
Overall design
25
3.2
Study rationale and justification for design
26
3.3
Number of subjects and investigational sites
26
3.4
Study duration
26
3.5
Randomization
27
3.6
Blinding
27
3.6.1
Emergency unblinding
27
3.7
Medical history
27
3.8
Previous and concomitant therapies
27
3.8.1
Definition
27
3.8.2
Categories
27
3.8.3
Authorized concomitant therapies
28
3.8.4
Prohibited concomitant therapies
28
3.8.5
Documentation and recording instructions
29
4.
STUDY POPULATION ..........................................................................................................29
4.1
Subject information and informed consent
29
4.2
Clinical study population characteristics
30
4.2.1
Inclusion criteria
30
4.2.2
Exclusion criteria
31
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4.3
Subject identification number
32
4.4
Procedures/Reasons for subject discontinuation/withdrawal
32
4.5
Suspension or premature termination
33
5.
STUDY INTERVENTION......................................................................................................34
5.1
Description of the investigational device
34
5.2
Description of the reference product
35
5.3
Additional products and materials
35
5.4
Packaging and labelling
36
5.5
Device accountability and storage
37
5.6
Instructions for use and administration
37
5.6.1
Reconstitution instructions
38
8 mL Reconstitution with addition of 1 mL 2% lidocaine
38
17 mL Reconstitution with addition of 1 mL 2% lidocaine
39
5.6.2
Pre-treatment procedure
40
5.6.3
Treatment procedure
41
5.6.4
Treatment regimen (dose and interval)
42
5.6.5
Post-treatment care
42
5.6.6
Post-trial provisions
42
5.6.7
Treatment compliance
43
6.
EFFECTIVENESS ASSESSMENTS .....................................................................................43
6.1
Photography
43
6.2
Galderma Décolletage Scale (GDS)
43
6.3
Global Aesthetic Improvement Scale (GAIS)
44
7.
SAFETY ASSESSMENTS ......................................................................................................49
7.1
Assessment of AEs by direct questioning to subject and evaluation of subject
49
7.2
Subject diary data
49
7.3
Laboratory assessment/Pregnancy testing
50
7.6
Adverse events
52
7.6.1
Definition of an Adverse Event (AE)
52
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8.11
Visit 6, Safety follow-up (1 month [+ 2 weeks] after Treatment 4) – for subjects that received 
treatment at Visit 5a.
64
8.12
Visit 7, Follow-up (month 6 [+ 2weeks] after baseline) - all subjects
64
8.13
Visit 8/Final visit/Early termination, (month 9 [±2 weeks] after baseline) - all subjects
65
8.14
Unscheduled Visits
65
9.
STATISTICAL DESIGN AND ANALYSIS..........................................................................65
9.1
General
65
9.2
Analysis populations
66
9.3
Demographics, baseline assessments, and subject characteristics
66
9.4
Effectiveness analysis
66
9.5
Safety analysis
66
9.6
Handling of missing data
67
9.7
Interim analysis
67
9.8
Independent data monitoring committee
67
9.9
Withdrawals and deviations
67
9.10
Sample size
68
10. DATA HANDLING AND MANAGEMENT ........................................................................68
10.1
Protection of Personal Data
68
10.2
Personnel training
69
10.3
Data management and documentation
69
10.3.1
Data entry and collection
69
10.3.2
Source documentation
70
10.3.3
Archiving / record keeping
71
10.4
Quality control / quality assurance
71
10.4.1
Quality Control
71
10.4.2
Quality Assurance
72
10.4.3
Changes to the Clinical Investigation Plan
72
11. ETHICAL CONSIDERATIONS............................................................................................72
11.1
Statement of ethical compliance
72
11.2
Application to institutional review board (IRB) and regulatory authorities (RA)
72
12. FINANCING, INDEMNIFICATION AND INSURANCE..................................................73
13. PUBLICATION POLICY.......................................................................................................73
14. REFERENCES.........................................................................................................................74
15. APPENDICES ..........................................................................................................................75
Appendix 1 Investigator Signature Page .......................................................................................75
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List of Tables
Table 1
Description of the Investigational Study Device .............................................................34
Table 3
Grading for subject diary data.........................................................................................50
Table 4
Fitzpatrick Skin Types (FST)...........................................................................................59
List of Figures
Figure 1
Treatment area boundaries...........................................................................................41
       
       
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2.2
Safety objectives and endpoints
Safety objective: 
To evaluate the safety of Sculptra for correction of wrinkles in the décolletage area.
Safety endpoints:
1. Incidence, intensity, time to onset and duration of Adverse Events (AE)s 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.
3.
STUDY DESIGN
3.1
Overall design
This is a prospective study to evaluate the safety and effectiveness of Sculptra for correction of 
wrinkles in the décolletage area. 
Approximately 30 subjects will be enrolled in the study and randomized 1:1 to receive either 
Sculptra reconstituted with 8 mL SWFI with the addition of 1 mL 2% lidocaine hydrochloride 
(HCl) or Sculptra reconstituted with 17 mL SWFI with the addition of 1 mL 2% lidocaine HCl. 
Subjects will be stratified by GDS severity score (moderate or severe) and study center. 
Eligible subjects will perform a screening visit and baseline visit; these visits may be combined, if 
appropriate. Eligible subjects will be offered treatment with Sculptra in four sessions spaced one 
month (+2 weeks) apart. 
Subjects will be injected with Sculptra by the Treating Investigator at Baseline. Sufficient amount 
of product, as determined by the Treating Investigator, should be injected to achieve optimal 
correction, which is defined as at least a one grade improvement on the GDS and best correction 
that could be achieved as agreed upon by the Treating Investigator and the subject. Three 
additional treatment sessions may be performed if needed to achieve optimal correction, as 
determined by the Treating Investigator and subject. Treatment will stop when optimal correction 
has been achieved and subsequent visits will be follow-up visits. 
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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.
3.8.5
Documentation and recording instructions
Prior and concomitant therapies are to be recorded in source documents and 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, or dose modification for a chronic condition.
4.
STUDY POPULATION
The study population will comprise adult women, aged 22 years or older, with intent to undergo 
correction of décolletage wrinkles. Subjects must have a GDS score of 2 (moderate) or 3 (severe) 
at enrollment. Study Inclusion criteria are presented in Section 4.2.1. Study Exclusion criteria are 
presented in Section 4.2.2. 
4.1
Subject information and informed consent
The Sponsor will provide an approved sample subject information and informed consent form 
(ICF) to each site. Prior to performing any study procedure, the subject must be informed (in non-
technical terms) by the Investigator (or designee) orally, and in writing, about the nature, 
importance, intended purpose, possible benefits, possible risks of the current trial and the opinion 
of the Institutional Review Board (IRB). Furthermore, they will be informed about randomized 
allocation to treatment groups, and alternative treatments available. The subjects will be informed 
that the participation in the trial is entirely voluntary and that they might withdraw from the study 
at any time without stating any reason and without prejudicing future medical treatment.
Subjects must also be informed that clinical records relevant to the study may be disclosed to the 
Sponsor, the monitor, a quality assurance auditor and to authorities responsible, in order to verify 
adherence to applicable laws and GCP. 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. The subject must be assured that all personal data will be treated with the 
utmost confidentiality. 
The information shall be provided in a language clearly and fully understandable to the subject.
Subjects must be allowed sufficient time to make a decision and consent freely to participate in the 
study. Subjects will be required to read, sign, date the ICF, summarizing the discussion prior to 
screening/ before any study-related activities are performed. Subjects will sign and date one copy 
of the ICF, the Investigator/designee providing the information and obtaining the consent will also 
sign. The copy will be retained by the subject and the original will be retained on file by the 
Investigator. By signing the ICF, subjects agree that they will complete all evaluations required by 
the study, unless they withdraw voluntarily, or are terminated from the study, for any reason.
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. The subjects 
will be recognizable on the photographs, but their names will not be disclosed.
If information concerning the device and/or the trial that may be relevant to the subject becomes 
available during the study, the Sponsor will provide this to the Investigator (in written form) and 
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4.2.2
Exclusion criteria
The presence of any of the following exclusion criteria excludes a subject from enrollment in the 
study:
1. Known/previous allergy or hypersensitivity to any of the Sculptra constituents. 
4. Previous tissue augmenting therapy, contouring or revitalization treatment in the 
décolletage, with any of the following prior to baseline visit: 
5. Any plastic surgery or permanent surgical implant in the treatment area. 
8. Previous treatment/procedure in the treatment area in the previous 6 months that would 
interfere with the study injections and/or study assessments, e.g.: 
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4.3
Subject identification number
Prior to any study procedures being conducted, the subject must sign the ICF. Each subject who 
has signed the ICF will be assigned a screening number. Upon randomization, each subject will be 
assigned a subject identification number that will be allocated in ascending order within each 
center. A screen failure is a subject who signed the informed consent, but was never enrolled (i.e. 
was randomized and/or 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. 
4.4
Procedures/Reasons for subject discontinuation/withdrawal
Each subject must be advised in the 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’s discretion at any time.  
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5.2
Description of the reference product
Not applicable. 
5.3
Additional products and materials
The following will be supplied by the study sites:

Antiseptic (such as alcohol)

Topical or local anesthesia. 
vial, maximum of 2 vials administered per treatment session.  
Frequency intervals
Four (4) injection sessions with 1-month (+2 weeks) intervals.
Injection needle size
25 Gauge (G) thin wall needle
Mixing Instructions 
Sculptra will be reconstituted in 8 mL SWFI or 17 mL SWFI and used 
directly after mixing. 1 mL 2% lidocaine HCl will be added directly 
prior to injection.
Injection Depth
Subdermal regions
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(Note: Topical or local anesthesia may be used at the discretion of the Treating Investigator before 
the treatment. The type of anesthesia, administration route, product name, and quantity used must 
be recorded in the eCRF.)
25 G sterile needles to be used for treatment is provided by the Sponsor. 
The following supplies are for reconstitution of Sculptra and for the addition of lidocaine and are 
to be provided by the end-user:
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Diary data will be counted and displayed separately from other AE data. 
Table 3
Grading for subject diary data
Category
Description
None
Symptom did not occur in treated area being evaluated
Mild
Tolerable
Moderate
Affects Daily Activities 
Severe
Disabling
7.3
Laboratory assessment/Pregnancy testing
For all women of childbearing potential, including those currently using contraception, a urine 
pregnancy test will be performed at screening and all injection visits (prior to treatment). The test 
result must be negative for the subject to receive any treatment with the study device. The test result 
will be documented in source data and the eCRF.
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7.6
Adverse events
7.6.1
Definition of an Adverse Event (AE)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other personsa, whether or not related 
to the study product. 
This definition includes:
a) events related to the investigational product or the reference product
b) events related to the procedures involved
7.6.2
Definition of a Serious Adverse Event (SAE)
An SAE is an AE that:
a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
1. a life-threateningb illness or injury, or
2. a permanent impairment of a body structure or body function, or
3. in-patient or prolonged hospitalizationc, or
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) led to fetal distress, fetal death, or a congenital abnormality 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 7.8.3).
7.6.3
Definition of Unanticipated Adverse Effect 
An anticipated AE for Sculptra is any AE included in the study specific IFU. An unanticipated 
adverse device effect is any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, the investigational device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence, or any other 
unanticipated serious problem associated with a device that relates to the right, safety or welfare of 
the subject (see US requirement CFR 812.3 (s)).
                                                
a For users or other persons, this definition is restricted to events related to the investigational device.
b 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).
c Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without serious deterioration 
in health, is not considered a SAE. (Source: ISO14155:2011).
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7.6.5
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 subsequent 
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. Details of pregnancy reporting 
are outlined in Section 7.8.5.
7.7
Safety recording instructions
Each subject with an AE occurring after enrollment through study exit should be fully recorded in 
the source document(s) for further transcription into the eCRF. Each subject should be questioned 
about AEs at each study visit following randomization and treatment. 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 site personnel, subject diaries, or spontaneous reports from the 
subjects or their relatives. 
When an AE is related to a device deficiency (refer to Section 7.9), 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 separately in 
the Investigator file, and the eCRF. 
Investigators, or other study site 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 7.7.1)
f)
Seriousness (serious or not serious, according to definition in Section 7.6.2)
g) Causal relationship to study product or study product injection procedure (yes or no, see 
Section 7.7.2)
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.
The pre-defined, expected post-treatment events shall be assessed separately. These events shall be 
collected daily by subjects in a diary for up to 28 days after each treatment.  
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The following information should be provided when reporting an AESI: 

Study Number CTN 43USSA2112

Subject identification (age, subject number and initials) 

Date and time when the AE occurred 

Adverse event description 

Medical history related to the event

Treatment specification 

Seriousness of the event 

Relatedness to study device or procedure 

Event outcome (with resolution date and time, if applicable) 

Prior exposure to similar device  

Investigations performed as a result of the AE

Interventions for treatment of the AE

Name and signature of Investigator
If the Investigator assesses an AESI to be serious, an SAE report should be submitted as specified in 
Section 7.8.3. 
Upon receipt of the AESI report, the Medical Monitor and Sponsor will review the information 
provided, assess the event, and report as applicable to RA and IRB.   
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to the pregnant woman which fulfil 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.
7.8.6
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 device 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 the subject is lost to follow-up. Follow-up information shall be reported on the 
AE follow-up form.
7.8.7
Reporting and follow-up of events occurring after subject termination of the study
All AEs with a causal relationship to the study device 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 7.7. The report can be sent via e-mail according to contact details 
specified in Section 7.8.2. The events shall thereafter be followed-up until resolved, considered 
chronic or stable, or the subject is lost to follow-up.
7.9
Device deficiencies
7.9.1
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, safetyd, or performance.
Note: Device deficiencies include malfunctions, use errors, and inadequate labelling.
7.9.2
Recording instructions
When a device deficiency is discovered, Part A of the clinical study complaint form must be 
completed by the Investigator and the source data recorded in the eCRF. The type of complaint 
must be described and injury to the subject or user, or unintended exposure to study device, must be 
reported as applicable. If an injury has occurred, an AE or an SAE form must be completed as 
applicable (refer to Section 7.8). If no SAE was experienced as a result of the device deficiency, the 
Investigator must assess whether or not the device deficiency could have led to an SAE if:

Suitable action had not been taken,

Intervention had not been made or,

Circumstances had been less fortunate
In Part B of the clinical study complaint form, the Sponsor will make the same assessment. 
7.9.3
Reporting of device deficiencies
The Investigator must 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 must 
be reported to the CRO within 24 hours after the Investigator’s awareness (for contact information, 
see Section 7.8.2). If the form is completed within the eCRF system, refer to the eCRF completion 
guidelines.
                                                
d Inadequacy of device safety refers to properties of the device which could have or have led to an AE.
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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 Investigator is responsible 
for reporting it to the IRB.
The deficient study device shall be retained by the study site until the Sponsor has confirmed 
whether the device shall be returned to the Sponsor for further evaluation, or if it can be destroyed 
at the study site.
7.10 Independent data monitoring committee
Not applicable to this study.
7.11 Study Stopping rules
8.
DESCRIPTION OF STUDY VISITS
A description of the study visits is provided in the
A written signed informed consent (including Health Insurance Portability and Accountability Act 
of 1996 (HIPAA)) must be obtained prior to performing any study-related evaluations and/or 
procedures. The subject must be provided with a fully completed dated and signed copy.
8.1
Visit 1 - Screening (Day -30 to Day 1) – all subjects
The following activities and screening assessments will be performed within 30 days prior to 
baseline. 
Note: The screening visit and baseline visit (Day 1) may be performed on the same day. 

Obtain Informed Consent prior to conducting any study specific procedure. 

Assess eligibility: Review inclusion/exclusion criteria. 

Perform Urine Pregnancy test for all females of childbearing potential. Test result must be 
negative for the subject to be eligible for the study. 

Obtain demographic and baseline data: date of birth, height, weight, cup size, ethnicity, race 
and Fitzpatrick Skin Type (FST). 
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o
FST is a skin classification system that categorizes different skin colors, and their 
reactions to ultraviolet (UV) light.(21) For determination of the FST, see Table 4.
o
Height and cup-size may be self-reported, weight must be measured at the clinic. 

Record the subject’s medical history (including any prior dermatological procedures or 
breast procedures (e.g. augmentation, implants, breast reduction surgery)). 

Record the subject’s prior and concomitant therapies. 

 
 

GDS assessment – Treating Investigator. 

Schedule the baseline treatment visit (Day 1) if performed on a different day than screening.
8.2
Visit 2a, Baseline and First Treatment (Day 1) - all subjects
The screening visit and baseline visit (Day 1) may be performed on the same day. If the screening 
visit and baseline visit are performed on the same day assessments will not be duplicated.
Assessments prior to treatment:

Re-confirm eligibility criteria 

Obtain weight measured at clinic.

Review for changes in concomitant therapies. 

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. 

Record the subject’s medical history 

Randomize the subject.
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
Obtain Photography 

 
 

GDS assessment – Treating Investigator 

Once the subject is deemed eligible for treatment by the Treating Investigator, the following 
procedures should be completed: 

Sculptra administration 

Evaluate the subject for post-treatment AEs – Treating Investigator. 

 

Evaluate for device deficiencies. 

Dispense diary and instruct subject on daily diary completion. Remind subject to bring the 
diary to the next on-site visit. 

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8.2
Visit 3a, Treatment 2/Follow-up (1 month [+ 2 weeks] after Treatment 1)
– all subjects 
Assessments prior to treatment:

Re-confirm eligibility criteria. 

Review for changes in concomitant therapies.

Perform Urine Pregnancy test for all females of childbearing potential (prior to treatment, if 
applicable). Test result must be negative for the subject to be eligible for treatment. 

Obtain Photography.


AE assessment.

Collect subject diary from treatment 1.

GAIS assessment – Treating Investigator and Subject.

GDS assessment – Treating Investigator.


Schedule the next on-site visit (1 month [+ 2 weeks] after Treatment 2).
Treatment and assessments post-treatment, for subjects who receive a second treatment: 

Sculptra administration (optional). 

Evaluate the subject for post-treatment AEs – Treating Investigator. 

 

Evaluate for device deficiencies. 

Dispense diary and instruct subject on daily diary completion. Remind subject to bring the 
diary to the next on-site visit. (If applicable, if a second treatment is administered.)
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
Evaluate for device deficiencies. 

Dispense diary and instruct subject on daily diary completion. Remind subject to bring the 
diary to the next on-site visit. (If applicable, if a fourth treatment is administered.)
8.11 Visit 6, Safety follow-up (1 month [+ 2 weeks] after Treatment 4) – for 
subjects that received treatment at Visit 5a.

Review for changes in concomitant therapies.

AE assessment.


Collect and review subject diary.
8.12 Visit 7, Follow-up (month 6 [+ 2weeks] after baseline) - all subjects

Obtain weight measured at clinic.

Review the subject’s concomitant therapies.

Obtain Photographs.

Assess for AEs- Treating Investigator

 
 
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All statistical analyses, including summary tables and data listings, will be performed using SAS. 
Confidence intervals will be two-sided and constructed at a confidence level of 95%. 
All endpoints will be summarized descriptively. Continuous endpoints will be summarized using 
mean, median, standard deviation (SD), minimum and maximum values, for the observed value as 
well as the change from baseline. Categorical endpoints will be presented in frequency tables with 
number and percentage of observations for each level.
9.2
Analysis populations
The following populations will be defined:

Safety
Includes all subjects who were treated with Sculptra. 
Subjects are analyzed based on the as treated principle (i.e. 
according to the treatment actually received).

Intention-to-treat (ITT)
Includes all subjects who were randomized based on the as 
randomized principle (i.e. according to the treatment they 
were randomized to). 

Per protocol (PP)
Includes all subjects in the ITT who complete the visit 9 
months after baseline without any deviations considered to 
have substantial impact on the primary effectiveness 
outcome.
The ITT is the primary population for all effectiveness analyses. The primary effectiveness analysis 
will be repeated using the PP analysis set if there is at least a 10% difference in the number of 
subjects between the PP and ITT sets. Safety analysis is performed based on the safety population 
set. The disposition of subjects will be presented in tables and/or figures as appropriate.
9.3
Demographics, baseline assessments, and subject characteristics
Demographic endpoints, baseline assessments, and subject characteristics will be presented by 
treatment group, based on the ITT analysis set using descriptive statistics, as appropriate.
9.4
Effectiveness analysis
Continuous endpoints will be summarized using descriptive statistics, e.g. mean, median, SD, 
minimum and maximum values. Categorical endpoints will be presented in frequency tables with 
number and percentage of observations for each level.
Responder rate regarding GAIS and GDS will be presented together with a 95% confidence interval 
(based on the binomial distribution). The difference in responder rate regarding GAIS and GDS will 
be calculated between the two groups presented together with a 95% confidence interval.
No adjustment to the level of significance will be performed; p-values obtained for any endpoint 
other than the primary will only be provided for ease of interpretation of the results.
9.5
Safety analysis
The number and percentage of subjects reporting each pre-defined, expected, post-treatment 
symptom, as collected in the 28-day diary, will be presented in total and by maximum intensity. 
Number of days with the event will be presented by treatment group and category: 1, 2-7, 8-14, and 
15-28 days.
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All AEs will be coded according to medical dictionary for regulatory activities (MedDRA) and 
summarized by system organ class (SOC), preferred term (PT) and treatment.
AEs related to the study device or injection procedure and unrelated AEs will be presented by 
maximum intensity, SOC and PT. For related AEs, the number of days to onset and the duration of 
the event will be summarized by SOC and PT using mean, SD, min, max and median. Action taken 
for related AEs will also be summarized by SOC and PT. Serious AEs will be listed. To evaluate 
consistency of AEs across different subgroups, AEs will also be summarized by treatment group 
injection volume: 8 vs 17 mL. 
In addition, a summary of all AEs will be provided, which will include (but is not limited to):

number of subjects with at least one AE and number of events (in total as well as SAEs)

number of subjects with at least one related AE and number of events (in total as well as 
SAEs)

number of subjects with at least one un-related AE and number of events (in total as well as 
SAEs)

number of subjects who did not have an AE
9.6
Handling of missing data
The number of missing values will be summarized and reported as appropriate. For the ITT analysis 
of the Treating Investigator GDS Responder rate at Month 9 after baseline (primary endpoint), 
missing values will be assumed to be missing due to lack of effect. Therefore, the primary method 
of imputation will use the baseline observation carried forward (BOCF) method. Impact of missing 
data on the primary endpoint will be evaluated by performing sensitivity analysis based on the 
observed cases, as well as worst-case and best-case imputation in the ITT set. 
All other effectiveness endpoints will be evaluated based on the observed cases in ITT. 
Descriptive statistics of all safety data will be performed on observed cases in the Safety population
9.8
Independent data monitoring committee
Not applicable to this study.
9.9
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 CIP deviations will be listed individually, including subject number and observed 
deviation. Depending on the seriousness of the deviation, the subject may be excluded from the PP 
population, which shall be documented prior to database lock (DBL).
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10.2 Personnel training
The study monitor will ensure that the Investigator and study site personnel understand all 
requirements of the protocol, and their regulatory responsibilities as an Investigator. Training will 
be provided at the Investigator’s meeting and may also be provided at the study site, and/or by 
instruction manuals. In addition, the study monitor will be available for consultation with the 
Investigator and will serve as the liaison between the study site and the Sponsor.
Study sites must adhere to good documentation practice (GDP) for all maintained records and for 
any applicable changes to these records. GDP principles must be adhered to, and all records must be 
attributable, legible, contemporaneous, original, accurate, complete, chronological, consistent and 
permanent. All relevant study site personnel must undergo training in the key elements of GDP at 
the site initiation visit (SIV), and training must be documented for each person. 
10.3 Data management and documentation
Data management based on GCP refers to the activities defined to achieve safe routines to enter 
clinical data information into a database, efficiently and to avoid 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 CIP and 
the eCRF 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 MedDRA dictionaries as specified in the DMP. Safety data (SAE and if applicable AESI) 
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.
10.3.1
Data entry and 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 site before inclusion of 
the first subject.
Authorized study site personnel designated by the Investigator shall complete data collection. 
Appropriate training and security measures shall be completed with all authorized investigation site 
personnel prior to the study being initiated and any data being entered into the system for any 
subject.
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The study data is the sole property of the Sponsor and shall not be made available in any form to 
third parties without written permission from the Sponsor, except for authorized representatives of 
appropriate RA. At the end of the study, electronic data are retained by the Sponsor and a copy 
(provided by the vendor) is retained at the study site as part of the Investigator file. Any delegation 
of collection of data shall be specified and recorded.
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 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.
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 
Investigator 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 site 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 Investigator or 
his/her authorized designee. The appropriate study site personnel shall answer the queries in the 
eCRF within a reasonable timeframe. Answered queries will be audit trailed by the electronic data 
capture application, meaning that the name of study site personnel, time, and date are logged. 
Answered queries will then be closed by the appropriate study personnel (i.e. data manager, site 
monitor, etc.).
eCRF 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 the time of electronic signature. If an entry in an eCRF requires change, 
the correction shall be made in accordance with the relevant software procedures. 
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.
10.3.2
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.
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The Investigator is responsible for maintaining 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.
10.3.3
Archiving / record keeping
The Investigator/Institution shall permit study-related monitoring, audits, IRB 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 of study product accountability). The records shall be 
retained by the Investigator as required by local legislation and international guidelines. Any 
transfer of responsibility for storage of the records shall be documented and the Sponsor must 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 (SDV). In order to be able to perform SDV, information 
about each subject’s participation in the study must be detailed in the medical record or other 
relevant source. 
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. 
The Sponsor will inform the site(s) as to when these documents no longer need 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 DBL, a security sealed CD with electronic study data shall be provided 
by the eCRF vendor for archiving.
It is the Investigator’s responsibility to inform the Sponsor in writing if the Investigator file is 
moved or if the responsibility for the documents is transferred elsewhere.
10.4 Quality control / quality assurance
10.4.1
Quality Control
On-site 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 CIP, subsequent amendment(s), GCP and the applicable regulatory requirements. 
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Any CIP deviation shall be documented appropriately, verified, discussed, and collected by the 
monitor and appropriate actions will be taken. The Investigator is responsible for promptly 
reporting any deviations from the CIP 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 IRB if required by national regulations. Deviations will be reviewed to 
determine the need to amend the CIP or to terminate the study.
10.4.2
Quality Assurance
The study site may be subject to quality assurance audit by the Sponsor as well as inspection by 
appropriate RA. It is important that the Investigator and other relevant study site 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 site team shall provide a curriculum vitae (CV) or 
equivalent that demonstrates their qualifications to conduct the study. It is the responsibility of the 
Investigator 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.
10.4.3
Changes to the Clinical Investigation Plan
The Investigator and other site personnel involved in the study must not implement any changes to 
the CIP without agreement with the Sponsor and prior review and documented approval from the 
IRB and RA, if applicable, except where necessary to eliminate an immediate hazard to the 
subjects. All changes to the final CIP, or any other information given to the subject, must be 
documented in a dated and version-controlled written protocol amendment. However, 
administrative changes may be documented in the Sponsor file without requiring a protocol 
amendment. The Sponsor will assess if the changes require prior FDA approval and inform the 
Investigator when such approval has been received.
11. ETHICAL CONSIDERATIONS
11.1 Statement of ethical compliance
The study shall be conducted in compliance with the CTA, the clinical investigational plan (CIP), 
GCP, and applicable regional or national regulations. The study shall be conducted in accordance 
with the ethical principles that have their origin in the Declaration of Helsinki (1964, and its 
amendments in force at the initiation of the study) insofar as such revisions are consistent with US 
treaty obligations and in accordance with US law.(1)
The study shall follow the international standard for clinical study of medical devices for human 
subjects, International Organization for Standardization (ISO) 14155:2020 as applicable for US 
regulations and the International Conference on Harmonisation (ICH) guideline for GCP (E6) as 
applicable for medical devices.
11.2 Application to institutional review board (IRB) and regulatory 
authorities (RA)
It is the responsibility of the Principal Investigator (PI) to obtain approval of the 
CIP/CIP amendment(s) from the IRB. The study must not begin until the required favorable opinion 
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from the IRB has been obtained. The Investigator must file all correspondence with the IRB in the 
Investigator file and copies of IRB approvals must be forwarded to the Sponsor. Any additional 
requirements imposed by the IRB or regulatory authorities (RA) must be followed. 
The study requires application for approval from the US Food and Drug Administration (FDA). The 
study must 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 Investigator 
with a copy of the relevant document.
The collection, access to, processing, and transfer of protected health information, or sensitive 
personal data, must be carried out in accordance with applicable rules and regulations.
12. 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 
CIP 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/Investigator is obligated to 
maintain insurance coverage for their obligations in the clinical study in accordance with the CTA.
13. PUBLICATION POLICY
The Investigator’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 submit to a medical journal for a first joint publication of the results. All 
authors listed on the publication of results of this multicenter study must 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 resolvede. Conditions 1, 2, 3, and 4 must all be met 
for designation as an author. Those who do not meet all four criteria will be acknowledged. Among 
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.
                                                
e 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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15. APPENDICES
APPENDIX 1 INVESTIGATOR SIGNATURE PAGE
Signed agreement of the Clinical Investigation Plan (CIP)
Clinical Trial Number 
(CTN):
43USSA2112
Title of the CIP:
A prospective open-label study to evaluate safety and effectiveness 
of two different reconstitution volumes of poly-l-lactic acid (PLLA) 
for correction of wrinkles in the décolletage area
I, the undersigned, have read and understand the CIP specified above, and agree on the contents. 
The CIP, the clinical trial agreement (CTA) and the additional information given in the study 
specific instructions for use (IFU) and the report of prior investigations (ROPI) will serve as a basis 
for co-operation in this study.
Principal Investigator
Printed name 
Signature
Date
Study site
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Sign page:1 of 1
SIGNATURES PAGE
Date
Signed by
Justification
Approved by Technical Expert
Justification
Approved by Owner
Justification
Compiled by
Justification
Approved by
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PPD
PPD
PPD
PPD