Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic, Acne
Sponsor: University of Texas Southwestern Medical Center

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Pilot Study Investigating the Efficacy of Fat Grafting as a 
Treatment for Male and Female Facial Acne Scarring  
 
 
 
 
 
 
NCT04559022 
 
21 October 2021 
 
 
 
 
 

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1. Introduction and Purpose 
1.1 Purpose 
This single-center, clinical trial consists of a one autologous fat grafting treatment followed by 3-
month and 6-month post-treatment visits in order to assess the efficacy of fat grafting when used 
by men and women with facial acne scars. 
 
1.2 Primary Objectives 
Objective 1:  To assess the efficacy and tolerability of the autologous fat grafting when used on 
men and women with acne scars on the face.  Overall assessment of clinical outcome and safety 
will be based on clinic visits, Mirapex imaging, VISIA measurements, and clinical evaluation of 
pre- and post-treatment photos.  The subject’s assessment of satisfaction will also be verbally 
evaluated at each follow-up period.  Finally, both the clinician’s and subject’s assessment will be 
characterized using a clinician assessment scale at the 3-months and 6-month post-treatment 
visits.  
  
Standard, close-up, 3D, cross-polarized, and/or UV light photography will be utilized for 
evaluation for improvement in skin tone, texture, pore size, actinic sun damage, porphyrins, and/or 
skin age. High-resolution ultrasound (HRUS) will be utilized for assessment of skin thickness and 
density. Transepidermal water loss measurements will be used to evaluate barrier function of the 
skin epidermal layer to determine progress of epidermal healing after treatment. Optical coherence 
tomography will be used to noninvasively gather topographical and histologic images of pre- and 
post-treated skin. The BTC 2000 will be used to measure skin laxity, viscoelastic deformation, 
stiffness, energy absorption, elasticity, and deformation values of skin. Microscopic biopsies will 
also be collected pre- and post- treatment to correlated changes between skin measurements and 
histological changes and gene expression. The relationship between these modalities will provide 
a multifaceted assessment to gauge improvement in skin tone, texture, and pore size.  
 
1. Background 
Acne vulgaris is a chronic inflammatory condition that can result in permanent scarring.  There 
are a number of modalities currently in use or under investigation for the treatment of atrophic 
acne scars.  Microneedling has been used for at least the past 2 decades, and has been shown to 
result in scar improvement, as assessed by blinded evaluators using a quantitative scale (1).  
Histologically, collagen types I, III, and VIII, as well as total elastin levels were found to be 
increased when analyzing biopsy samples (2).  Additionally, microneedling has been combined 
with platelet-rich plasma for the treatment of acne scars.  Laser resurfacing has also been found to 
be an effective treatment for both active acne and acne scarring.  A variety of lasers have been 
utilized, including both CO2 and Erbium:YAG lasers.  Chemical peels using active ingredients 
such as tretinoin, glycolic acid, and trichloroacetic acid, have been investigated for the treatment 
of several conditions, including acne and acne scarring.  The theory behind these treatments is that 
these agents destroy the epidermis and/or dermis, leading to skin exfoliation and remodeling (3).  
Finally, dermal fillers are used in increase volume in depressed scars.  Options include human 
collagen derivatives, hyaluronic acid, and autologous fat (3).  Autologous fat has gained increasing 
popularity, as there is no risk of allergic reaction, since the fat is derived directly from the patient. 
 
 

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This is a single-site, pilot study at UT Southwestern Medical Center at Dallas in the Department 
of Plastic Surgery assessing the clinical effects of autologous fat grafting for the treatment of facial 
acne scarring. The Principal Investigator has been selected based on his expertise, qualifications 
(credentials, training, and medical specialty), subject access, previous clinical research, facilities, 
and interest in this particular field of research.    
 
2. Concise Summary of Project: 
3.1 Objective 
This investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for 
the treatment of acne scarring.  Overall assessment of clinical outcome and safety will be based 
clinic visits and evaluation of pre- and post- procedural photos. In conjunction with standard and 
close-up photography, we will also be using 3D imaging, cross-polarized imaging, UV imaging, 
high-resolution ultrasonography, optical coherence tomography, transepidermal water loss 
measurements, and/or BTC 2000 measurements. Additionally, we will be utilizing 0.33 mm skin 
biopsies to assess histological and genetic changes that occur below the skin surface as a result of 
this treatment.  The subject’s assessment of satisfaction will be characterized using a non-
parametric assessment scale at each follow-up period.   
 
3.2 Clinical Study 
Autologous Fat Grafting to the Face for the Treatment of Acne Scars 
This is a single-site, non-randomized, non-controlled study designed to follow at least fifteen (15) 
qualified and consenting subjects receiving 1 treatment of autologous fat grafting to acne scars 
present on the face.  The sample size determination of this study is based on the fact that this is a 
pilot study, as well as the Principal Investigator’s experience with previous studies.  These patients 
will receive one treatment, followed by two follow-up visits at 3-months and 6-months post-
treatment.  The acute effects of autologous fat grafting will be determined by subjective and 
objective analysis using standard, close-up, 3D, cross-polarized, and UV photography, high 
resolution ultrasound, optical coherence tomography, transepidermal water loss measurements, 
BTC 2000 measurements, and/or skin biopsies.  Additionally, the effects of this treatment will be 
analyzed at 3-months and 6-months post-treatment through clinician and subject assessments. 
 
This is a single-site study at UT Southwestern Medical Center at Dallas in the Department of 
Plastic Surgery. The Principal Investigator has been selected based on his expertise, qualifications 
(credentials, training, and medical specialty), subject access, previous clinical research, facilities, 
and interest in this particular field of research.   Subjects will be identified from Dr. Jeffrey 
Kenkel’s clinical practice at the University of Texas Southwestern Medical Center.  Subjects will 
be numbered sequentially in the order in which they qualify for entry into the study. 
 
At each follow-up visit, the treated areas will be clinically evaluated and photographed. Miravex 
3D photography may be used to take a 3D image of the skin.  The study will utilize the VISIA 
Skin Analysis system to obtain standard, cross-polarized, and UV images to analyze skin tone, 
texture, pore size, actinic sun damage, porphyrins, and/or skin age; the standard time for VISIA 
imaging should take approximate 5-10 minutes per subject.  High resolution ultrasound will be 
used to assess skin thickness and density; the standard time for use of high-resolution ultrasound 
should take approximately 5 minutes.  Transepidermal water loss (TEWL) measurements will be 
used to evaluate barrier function of the skin epidermal layer to determine progress of epidermal 

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healing after treatment. The standard time for TEWL measurements should take approximately 5 
minutes. Optical coherence tomography (OCT) will be used to noninvasively gather topographical 
and histologic images of pre- and post-treated skin. The standard time for OCT should take 
approximately 5-10 minutes. The BTC 2000 will be used to measure skin laxity, viscoelastic 
deformation, stiffness, energy absorption, elasticity, and deformation values of skin. The standard 
time for BTC 200 should take approximately 5 minutes. 
 
Biopsies will be taken using 0.33mm WellTech Rapid Core 0.33mm Biopsy Punch. Biopsies will 
allow investigators to correlate changes seen in skin measurements with histology and gene 
expression. Time for two biopsies will take approximately five minutes. 
 
Finally, the subject’s global aesthetic improvement assessment will be completed at the two 
follow-up visits, as well as blinded evaluations of pre- and post-treatment standard photographs 
and the Clinician’s Global Aesthetic Improvement Scale (CGAIS). 
 
Follow-up for any identified adverse events will be reported to the IRB. 
 
3. Subject Enrollment 
4.1 Informed Consent Form 
An IRB-approved informed consent form (ICF), consistent with the requirements in 21 Code of 
Federal Regulations (CFR) 50.25, will be given to each candidate subject before participation in 
any study procedures.  The candidate subject will be given as much time as needed to read the ICF 
and will have the opportunity to have any study related questions answered to their satisfaction 
prior to signing the ICF.  If further questions exist, the candidate subject will be given sufficient 
time during the first visit to clarify open questions and concerns regarding the study and/or the ICF 
with the Investigator, Sub-Investigator or the study coordinator prior to signing.  An original 
signed copy for each subject participating in the study will be retained in the study file and each 
subject will receive a signed copy.  The candidate subject will be ineligible to participate in this 
study without a signed ICF.   
 
4.2 Subject Identification 
Subjects will be assigned AS (acne scar) followed by a a 2-digit number (ex. AS01)  which, when 
used in conjunction with the clinical study number, will uniquely identify every subject on the 
study.  This number will remain with the subject throughout the study and should be used in all 
references to the individual in this study. No number will be reassigned once the study begins.  
 
4.3 Eligibility Criteria 
 
Inclusion Criteria 
1. Men and women 18 to 60 years of age having general good health. 
 
2. Individuals deemed by the Investigator to have a significant amount acne scarring on the 
face and that desire correction of this condition. 
 
3. Individuals willing to withhold aesthetic therapies to the areas of the hand being treated or 
judged to potentially impact results by the Investigator (e.g. soft tissue fillers and/or any 
resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL 

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(intense pulsed light), peels, laser treatments, and tightening treatments, etc.) for the 
duration of the study. Waxing and threading is allowed but no laser treatments outside of 
the study. 
 
4. Individuals that are willing to provide written informed consent and are able to read, speak, 
write, and understand English.  
 
5. Individuals willing to sign a photography release. 
 
6. Willingness to cooperate and participate by following study requirements for the duration 
of the study and to report any changes in health status or medications, adverse event 
symptoms, or reactions immediately. 
 
Exclusion Criteria 
1. Individuals diagnosed with known allergies to general skin care products. 
 
2. Individuals who have presence of an active systemic or local skin disease that may affect 
wound healing. 
 
3. Individuals with sensitivity to topical lidocaine. 
 
4. Individuals who have physical or psychological conditions unacceptable to the 
Investigator. 
 
5. Individuals who have a recent history of significant trauma to the areas to be treated (< 6 
months). 
 
6. Individuals who have severe or cystic active and clinically significant acne on the area(s) 
to be treated.  Clinically significant acne is defined as a subject whom has > 5 active 
inflammatory acne lesions (including acne conglobate, nodules, or cysts) in either the right 
or left treatment area.  
 
7. Individuals who have a recent or current history of inflammatory skin disease, infection, 
unhealed wound or clinically significant acne in the proposed treatment areas.  
 
8. Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g. 
Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyositis, 
etc.). 
 
9. Individuals who currently have or have a history of hypertrophic scars, or keloid scars.  
 
10. Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated 
and/or with a history of skin cancer. 
 
11. Individuals who have the inability to understand instructions or to give informed consent. 
 

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12. Individuals who have had microdermabrasion or glycolic acid treatment to the treatment 
area(s) within one month prior to study participation or who will have this treatment during 
the study. 
 
13. Individuals who have a history of chronic drug or alcohol abuse. 
 
14. Individuals undergoing concurrent therapy that, in the Investigator’s opinion, would 
interfere with the evaluation of the safety or efficacy of the study device. 
 
15. Individuals who, in the Investigator’s opinion, have a history of poor cooperation, 
noncompliance with medical treatment, or unreliability.  
 
16. Individuals who have a history of the following cosmetic treatments in the area(s) to be 
treated: 
 Skin tightening procedure within the past year; 
 Injectable filler of any type within the past: 
o 12 months for Hyaluronic acid fillers (e.g. Restylane) 
o 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse) 
o 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra) 
o Ever for permanent fillers (e.g. Silicone, ArteFill) 
 Neurotoxins within the past three months; 
 Ablative resurfacing laser treatment; 
 Non-ablative, rejuvenative laser or light treatment within the past six months; 
 Surgical dermabrasion; 
 Had a chemical peel or dermabrasion, of the dorsum of the hand within four weeks 
 
17. Individuals with a history of using the following prescription medications: 
 Accutane or other systemic retinoids within the past six months; 
 Topical Retinoids within the past two weeks; 
 Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA, 
BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with 
tretinoin, etc.) within four months; 
 Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic 
medication known to affect skin aging or dyshcromia (devices containing 
alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or 
licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract 
(topically), emblica extract, etc.) within two weeks;  
 Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID 
use); and/or 
 Psychiatric drugs that in the Investigator’s opinion would impair the subject from 
understanding the protocol requirements or understanding and signing the informed 
consent. 
 
18. Individuals who are nursing, pregnant, or planning to become pregnant during the study 
according to subject self-report. 
 

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19. Individuals having a health condition and/or pre-existing or dormant dermatologic disease 
on the body (e.g., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-
skin pigmentation conditions such as post inflammatory hyperpigmentation) that the 
Investigator or designee deems inappropriate for participation or could interfere with the 
outcome of the study. 
 
20. Individuals with a history of immunosuppression/immune deficiency disorders (including 
HIV infection or AIDS) or currently using immunosuppressive medications (e.g., 
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate 
mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by 
study documentation. 
 
21. Individuals with an uncontrolled disease such as asthma, diabetes, hyperthyroidism, 
medically significant hypertension or hypothyroidism. Individuals having multiple health 
conditions may be excluded from participation even if the conditions are controlled by diet, 
medication, etc. 
 
22. Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical 
procedures during the course of the study. 
 
23. Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal 
conditions on the back of the hand that might influence the test results in the opinion of the 
Investigator or designee. 
 
24. Individuals who have any condition, which in the opinion of the Investigator makes the 
patient unable to complete the study per protocol (e.g. patients not likely to avoid other 
cosmetic treatments to the treatment area; patients not likely to stay in the study for its 
duration because of other commitments, concomitant conditions, or past history; patients 
anticipated to be unreliable, or patients who have a concomitant condition that may develop 
symptoms that might confuse or confound study treatments or assessments). 
 
4.4 Subject Instructions 
 Wash off all facial make-up and skincare products at least 30 minutes prior to each 
scheduled clinic visit using the provided cleanser. No other topical products should be 
applied to the treatment area until the study visit has been completed.  If a subject 
arrives having not removed make-up and skincare products, she or he will be required 
to remove the residual product at the clinic and wait at least 20 minutes prior to 
procedures.  
 Blistering, bleeding, oozing, strong pain, persisting for more than 24 hours, or signs of 
infection (e.g., pus, drainage, fever) are cause for immediate concern and the subject 
will be instructed to contact the investigator and/or his designee, to be evaluated and 
potentially treated if they notice these symptoms.  
 Avoid extended periods of sun exposure and all use of tanning beds for the duration of 
the study. Extra care should be taken to wear protective clothing and avoid sun 
exposure from 10 AM to 4 PM.  
 Individuals must refrain from using any anti-aging, acne, and acne scar products or 

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devices and beginning the use of any new skincare products or devices other than the 
assigned test material for the duration of the study. 
 Following treatment, subjects may experience bruising and swelling and the harvest 
and treatment sites in the weeks following treatment.  Subjects may be sore in the days 
following treatment and should refrain from physical activity for at least one week. 
 
Study Design 
5.1 Outline of Procedures 
Procedures/Time Points: 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Screeni
ng/Base
line  
(-14 to 0 
day[s]) 
Day 1 
 (± 3 
days) 
3-months  
post-
treatment 
(± 3 days) 
6-months  
post-
treatment  
(± 3 days) 
ICF, and qualification/enrollment 
paperwork 
X 
 
 
 
Urine pregnancy test 
X 
 
 
 
Physical Examination of Acne 
Scarring 
X 
 
 
 
Treatment of facial acne scars 
 
X 
 
 
Non-Invasive Procedures (Aquaflux, 
BTC-2000, DUB, OCT) 
 
X 
X 
X 
Biopsies 
 
X 
X 
X 
Error! Reference source not 
found. (Miravex, VISIA, and 
Standard Photography) 
 
X 
X 
X 
Error! Reference source not 
found. 
 
 
X 
X 
Error! Reference source not 
found. Evaluation and CGAIS 
 
 
X 
X 
 
5.2 Pre-Study Procedures 
1. Prior to the start of the study, potential subjects will be screened for eligibility 
requirements by telephone or e-mail.   
2. Prospective subjects will be informed of the study visit instructions, as detailed in 4.4.   
3. An appointment time to visit the clinic will also be scheduled. 
 
5.3 Screening: Visit 1 (-14 to 0 day[s]) 
1. Candidate subjects will be given an IRB-approved Informed Consent Form (ICF), as 
detailed in section 4.1, with adequate time for review. The Investigator and/or his designee 
will address questions and concerns raised by the subject.  If the subject agrees, they will 
sign one copy of the ICF.  They will receive a copy, and the original will be kept in the 
study file. 
 
2. Candidate subjects will be screened to ensure that they meet all of the study criteria.  A 

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brief medical history will be taken, and the subject will be questioned about the inclusion 
and exclusion criteria. 
 
3. If the subject is of child-bearing potential, a pregnancy test will be performed. 
 
4. Candidate subjects that sign the initial paperwork will be assigned a screening number. 
 
5. The treatment area will be assessed by a member of the research team. 
 
This visit will take 30-45 minutes.  This visit may be conducted at the same time as Visit 2, the 
first treatment. 
 
5.4 Treatment Visit: Visits 2 (Day 1) 
 
1. A clinician will record concomitant medications and will ask subjects if they have 
experienced any changes in their health since the previous visit. If an adverse event (AE) 
is reported then the Investigator will be informed and an AE form will be completed.  
 
2. Subjects will acclimate to ambient temperature and humidity conditions for 15 minutes.  
To ensure compliance in acclimation period, the time will be noted in the CRF by research 
staff. 
 
3. After acclimation, subjects will participate in photography procedures as described in 
section 6.2.  Additionally, subjects will have measurements taken using the Miravex 3D 
Imaging and VISIA Complexion Analysis as described in section 6.2.  Additionally, 
TEWL, OCT, high frequency ultrasound, and BTC-2000 measurements will be obtained. 
 
4. Patients will undergo two 0.33mm biopsies using WellTech Rapid-Core 0.33mm Biopsy 
Punch pre-treatment. The biopsy site will be chosen by the PI and marked in the patient’s 
file, to keep consistency at the follow-up visits. One biopsy will be used for histological 
studies and the other for gene expression studies. 
 
5. The procedure will be performed in clinic under a local anesthetic.   
a. The harvest site will be anesthetized using a local numbing agent, 1/4% xylocaine 
with epinephrine.  We will inject the acne scar sites with a local anesthetic as well, 
½-1% xylocaine with epinephrine.   
b. After 10 minutes the donor site will be prepped and draped, and the fat will be 
harvested with standard fat harvesting techniques.  The area where fat is harvested 
will require a small access site to remove the fat.  This will be closed with an 
absorbable suture.   
c. The fat will be prepared by spinning using a centrifuge at 3000 rpm for two minutes. 
The serum and oil will be separated, and each cc of injectable aspirate will contain 
0.9cc of fat and 0.1cc of oil.   
d. The face will be prepped and then the fat injected using 25 and 22 G needles.  
 
6. Before leaving, the research team will review post-treatment expectations and 

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management with the subject. 
 
These visits will take approximately 2 hours. 
 
In the weeks following treatment, the subject will return up to 2 times in order to assess their 
face and the harvest sites.  These standard of care visits will take no longer than 30 minutes and 
are simply to assure the subjects are healing well. 
 
5.5 Post-Treatment Visits: Visit 3 (3-Months Post-Treatment) and Visit 4 (6-Months Post-
Treatment) 
1. A clinician will record concomitant medications and will ask subjects if they have 
experienced any changes in their health since the previous visit. If an adverse event (AE) 
is reported then the Investigator will be informed and an AE form will be completed.  
 
2. A clinician will perform a physical examination to ensure that the wound sites are still 
healing properly. 
 
3. After a 15-minute acclimation to ambient temperature and humidity conditions, subjects 
will participate in the following procedures:  
 
 Photography procedures as described in section 6.2. 
 Subject’s self-assessment on improvement as described in section 6.1. 
 TEWL, OCT, high frequency ultrasound, DUB measurements 
 Two 0.33mm microbiopsies at the same site as those obtained pre-treatment 
 
These visits will take about 45 minutes. 
 

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5.6 Event Follow-up Visits (Investigator or designee)  
If a potential adverse event is reported by the subject or identified during examination, the Investigator 
will contact the subject to schedule an Event Follow-up Visit.  At this visit the Investigator or their 
designee will: 
 
a.  Obtain a complete history of the event in question as well as conduct an examination of 
the subject and determine if the reported event qualifies as an Adverse Event.  If the event 
is determined to be an Adverse Event, an Adverse Event (AE) case report form and Event 
Follow-up (EF) Visit case report form must be completed.  One AE case report form 
should be used to track the history of an individual AE throughout the period of the study.   
b. 
Collect an updated medical and surgical history along with recording of concomitant 
medications or treatments. 
c. 
Take photographs of the subject with attention to the area in question. 
d. 
Render treatment for the event, if any, as determined by the medical judgment of the 
investigator.  
 
6. Assessments 
6.1 Global Aesthetic Improvement Assessments 
6.1.1 Clinician’s Global Aesthetic Improvement Scale (CGAIS) 
Rating 
Description 
1 
Very Much Improved: Optimal cosmetic result in this subject. 
2 
Much Improved: Marked improvement in appearance from the initial 
Biopsy 
Month 3 
Visit 
1 
1 
3 
4 
Tx 
1 
2 
2 
3 
Day 1 
Month 6 

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condition, but not completely optimal for this subject. 
3 
Improved: Obvious improvement in appearance from initial condition, 
but a re-treatment is indicated. 
4 
No Change: The appearance is essentially the same as the original 
condition. 
5 
Worse: The appearance is worse than the original condition. 
  
 
6.1.2 Subject Global Aesthetic Improvement Scale (SGAIS) 
Rating 
Description 
1 
Very Much Improved: Optimal cosmetic result. 
2 
Much Improved: Marked improvement in appearance from the initial 
condition, but not completely optimal. 
3 
Improved: Obvious improvement in appearance from initial condition. 
4 
No Change: The appearance is essentially the same as the original 
condition. 
5 
Worse: The appearance is worse than the original condition. 
 
6.2 Photography Procedures 
Prior to photography procedures, clinic personnel will ensure that subjects have a clean face and 
neck with no makeup as described in the study procedures. Subjects will remove any jewelry from 
the area(s) to be photographed and equilibrate for at least 15 minutes to ambient conditions within 
the clinic before any photographs are taken. Subjects will be provided with a black or gray matte 
headband to keep hair away from the face and instructed on proper headband placement.  
 
1. 
NIKON D7200 
Standard and close-up photography will be taken in the Department of Plastic Surgery’s 
clinical photography studio.  These photos will be utilized for evaluation of the fat 
grafting treatment for acne scarring. These photographs will be taken utilizing the 
Nikon D7200 at baseline, 3-month post-treatment, and 6-months post-treatment. 
 
2. 
VISIA Complexion Analysis 
Digital images will be taken using the VISIA Complexion Analysis System at 
baseline, 3-months post-treatment, and 6 months post-treatment.  Subjects will be 
instructed to adopt neutral, non-smiling expressions with their eyes gently closed for 
VISIA. Subjects will be carefully positioned for each photograph, directly facing the 
camera for the center view and turned at a 45° angle for the right and left side views.  
The scan will objectively measure spots, wrinkles, texture, pores, UV spots, brown 
spots, red areas and porphyrins.   
 
Standard lighting 1: visible (bright) 

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Standard lighting 2: visible (flat) 
Cross-polarized: UV-NF 
 
3.        Miravex 3D Imaging 
Miravex 3D Imaging will be performed in the Department of Plastic Surgery clinic to 
assess changes in volume of the subjects’ facial acne scars.  Images will be taken at 
baseline, 3 months, and 6 months post-treatment.  Image acquisition and analysis take 
less than 90 seconds. 
 
 
6.3 Blinded Evaluation 
Two trained blinded raters will be asked to presented randomized photos of subjects taken prior 
to treatment (day 1) and 6 months post-treatment.  They will be asked to record which order they 
believe the photos are in, before then after or after then before. After the blinded assessment has 
been completed, the two raters will be unblinded to the prior to treatment photo for CGAIS. 
Raters will assess the photos on a local computer and record answers on a worksheet distributed 
by the research team. 
 
7. Sources of Research Material 
Medical history (age, sex, skin type, recent sun exposure, allergies, current medications, major 
illnesses), standard photography, VISIA images, Miravex images, OCT images, high frequency 
ultrasound images, TEWL measurements, BTC 2000 measurements, biopsies, evaluations, 
responses to questionnaires, adverse events and treatment. 
 
8. Recruitment Methods and Consenting Process 
Subjects will be recruited from the existing practice of the Investigators, Campus News postings, 
and flyers placed at UT Southwestern Plastic Surgery Clinics. Subjects who present for treatment 
with fat grafting will have the study explained to them, will be asked about their willingness to be 
involved in the study, and their willingness to sign an informed consent form.  Included in this 
interview will be questioning from the investigator or staff member about any privacy concerns 
the individual may have. 
 
Prior to any study procedures each Subject will read and sign a Consent Form, explaining the 
purpose, design, risks and duration of the study.  This consent will include a photography release 
that allows the investigator or his designee to take recognizable and non- recognizable photographs 
of the subject.  If the subjects decline permission to be photographed, they may not participate in 
the study since the photographic documentation of treatment outcome is an important measure of 
evaluation.  
 
Subjects will also be paid $25 per research visit, and $35 for research visits with a biopsy.  
Subjects will receive $130 if all four research visits are completed.  Additionally, subjects will be 
compensated $5 for each wound check for which they return, for an additional compensation of 
up to $10.  A Clincard will be used for payment. 
 
9. Potential Risks 

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Bruising and Infection: (Rare < 1%)  
As with any superficial wound, there is a risk of infection.  This risk will be minimized by using 
sterile technique and performing proper wound care.  Furthermore, obtaining a detailed patient 
history prior to treatment will guide patient care. 
 
Transient edema and/or erythema: (Occasionally < 3%) 
Swelling is the most common complication of fat injection and can last up to 2 weeks.  Head 
elevation and ice packs on the grafted areas may alleviate these symptoms. 
 
Undercorrection/overcorrection/contour Irregularities: (Rare < 1%) 
Injecting inadequate or excessive amount of fat can lead to undercorrection or overcorrection of 
depressed areas, respectively.  The treatment will be performed by the PI, who has extensive 
experience with fat grafting. 
 
Scarring: (Rare < 1%) 
There is a small risk of scarring. However, this is minimized by proper technique and wound care. 
 
Allergic Reaction: (Rare < 1%) 
There is a possibility of an allergic or toxic reaction to anesthesia used to numb the areas. Subjects 
will be questioned with regard to any history of allergies and carefully monitored for signs of 
allergic reaction. 
 
Biopsy 
Risks associated with biopsy include: 1) scarring - a small risk of scarring, which can be 
minimized by proper technique and wound care; 2) allergic reaction - there is a possibility of an 
allergic or toxic reaction to anesthesia used to numb the areas. Subjects will be questioned with 
regard to any history of allergies and carefully monitored for signs of allergic reaction. 
 
Photography 
Subjects could be slightly uncomfortable during the photographic sessions when asked to 
position her body to take the photograph of their face. The subject may be uncomfortable with 
standing still for an extended period of time or from turning her head in various positions. 
Subjects may be sensitive to the bright and repeating flashes from the camera, which can 
sometimes cause headaches, irritation of the eyes, discomfort, after effects such as seeing spots, 
and in rare cases, could stimulate a migraine headache or epileptic seizure. 
 
Photographs include a risk of identification. Privacy will be protected to the greatest extent 
possible. Photos will only be identified by a unique subject identification number that contains 
no personal identifying information. For research purposes photos may be used in scientific 
publications 
 
 
10. Adverse Events 
 
10.1 Definition of an Adverse Event 
 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation where a 
subject is administered a pharmaceutical product/biologic (at any dose), OTC, cosmetic product 
or medical device and which does not necessarily require a causal relationship with a test article. 

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An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding, for example), symptom or disease temporally associated with the use of a medicinal 
product whether or not considered related to the medicinal product. The AEs will be recorded on 
the appropriate case report forms and source documents.  The Investigator or medical staff will 
evaluate all AEs as to their severity and relation to the test article. 
 
The severity of an AE will be graded as follows: 
 
Mild: 
Awareness of a sign or symptom but easily tolerated 
 
Moderate: 
Discomfort sufficient to cause interference with usual activity or to affect  
 
 
clinical status 
 
Severe: 
Incapacitating with inability to do usual activity or to significantly affect  
 
 
clinical status 
 
The relationship of an AE to the use of the study article will be assessed using the following 
guidelines, based upon available information: 
Unlikely 
No temporal association, or the cause of the event has been identified, or the  
 
test article cannot be implicated 
Possible 
Temporal association, but other etiologies are likely to be the cause;  
 
however, involvement of the test article cannot be excluded 
Probable 
Temporal association, other etiologies are possible, but not likely 
Definite 
Clear-cut temporal association 
Unknown 
 
 
10.2 Definition of a Serious Adverse Event  
A serious adverse event (SAE) is any experience or reaction occurring at any dose that results in 
any of the following outcomes: 
 death, 
 is life threatening, 
 inpatient hospitalization or prolongation of hospitalization, 
 a persistent or significant disability/incapacity, or 
 a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse event when, based upon appropriate medical 
judgment, they may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this definition. [Note:  The term “life-
threatening” refers to an event in which the subject was at risk of death at the time of event; it 
does not refer to an event that hypothetically might have caused death if it was more severe.] 
 
Hospitalization solely for the purpose of diagnostic tests, even if related to an AE, elective 
hospitalization for an intervention which was already planned before the inclusion of the subject 
in the study, and admission to a day-care facility may not themselves constitute sufficient 
grounds to be considered a SAE. Hospitalization is defined as being admitted to a hospital as an 
in-patient for greater than 24 hours. 
 

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10.3 Procedures for Reporting Adverse Events 
At each visit, the Investigator or designee will question the subject about adverse events using an 
open question and taking care not to influence the subject’s answer (e.g. “Have you noticed any 
change in your health since the last visit?”). 
 
Directed questioning and examination will be performed when appropriate. All reported AEs 
will be documented on the appropriate forms without omitting any requested and known 
information. Every time a concomitant therapy is reported during the study, an AE form will be 
completed if appropriate and the reason for the treatment noted. 
 
When an AE persists at the end of the study, the Investigator will ensure a follow-up of the 
subject until the event is satisfactorily resolved. 
 
Photographs will be taken to document any AEs if possible. 
 
 
10.4 Medical Treatment for Adverse Events and Serious Adverse Events 
For the duration of the study, medical assistance will be provided to the subject for study related 
problems at no expense, if in the opinion of the Principal Investigator, the reaction was caused by 
the use of the study device. UT Southwestern will make all medical arrangements and will 
provide appropriately selected doctors. 
 
Should a subject choose to see their own doctor, or seek any post-study medical treatment 
(except for any study-related treatment that is due to the negligence of UT Southwestern) 
reimbursement will be offered. 
 
 
10.5 Unanticipated Adverse Reactions 
Unanticipated adverse reactions are defined as any adverse reactions not listed as one of the 
anticipated reactions listed in the protocol and was not previously identified in nature, severity, 
or degree of incidence. 
 
 
10.6 Anticipated Reactions 
Expected side effects:  After the procedure, the skin will be red and swollen in appearance.  The 
patient many also experience skin tightness and mild sensitivity to touch on certain areas.  This 
will diminish significantly within a few hours following the procedure.  Swelling and bruising 
may should resolve within one to two weeks post-treatment.   
 
Symptoms of mild irritation, including the redness, bruising, and swelling listed above, will not 
be treated as adverse reactions if they are mild in nature. These conditions may or may not 
resolve over time. Symptoms that are persistent and moderate to severe in nature, or that involve 
elevation (e.g. edema, papules, vesicles, spreading) will be considered AEs. 
 
Unanticipated Reactions:  In rare cases, it is possible for a subject to develop allergic reactions to 
the test material(s). Rare allergic reactions can consist of severe contact dermatitis, granuloma(s) 
or systemic hypersensitivity. This risk is increased for individuals with a history of allergies, and 
individuals with asthma and/or a history of hives may also be affected. Subjects will be 
instructed to notify the clinic immediately if they experience an allergic reaction including rash, 

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hives, and itching. Also, hyperpigmentation, hypertrophic skin scarring, and scarring is a rare 
potential. 
 
The Investigator will have the final authorization to determine if a reaction will be considered an 
AE. 
 
 
11. Attrition 
Clinical studies may experience attrition. Subjects will be made aware that they are free to 
withdraw from the study at any time for any reason, without prejudice. Otherwise, every effort 
will be made to have subjects complete the study as stated in this protocol, ensuring subject 
safety and following the provisions of the informed consent form. Reasons for subject 
withdrawal may include an adverse event, subject’s request, protocol violation, lost to follow-up, 
or other reasons. Subjects lost from the study will be documented on a screening/enrollment log. 
 
If a subject fails to return for a scheduled examination, a representative of UT Southwestern will 
attempt to contact the subject and determine whether the subject has continued to follow study 
instructions and intends to continue participation in the study. If so, then the subject will be 
processed as soon as possible (± 3 days for rescheduled visit). Changes to the study schedule 
under these circumstances will be noted in the Screening and Enrollment Log. If a subject is 
unable to reschedule the visit within the appropriate window as indicated above, they will be 
dropped from study participation. 
 
12. Procedures to Maintain Confidentiality: 
This study will follow all applicable guidelines for the protection of human subjects for research 
as outlined in 21 CFR 50, in accordance with the accepted standards for Good Clinical Practice 
(GCP), International Conference on Harmonization (ICH), and the standard practices of UT 
Southwestern. 
 
All study records and information will be identified by the subject number. All subject identifiers 
will be removed from all documents. The link between subject name and study ID number will be 
kept in separate password-protected files. Documents containing identifying information will be 
kept in locked files in the research staffs’ locked office. All electronic study data will be password 
protected with access limited to members of the research team.  No direct identifying information 
will be shared with any outside entities.  Electronic data (electronic data entry - Case Report 
Forms) will be password protected.   
 
Photographs of subject's faces will be taken at enrollment, treatment and follow-up visits. These 
photographs will be identified by subject numbers and will not include any identifying marks 
[such as tattoos].  Subject confidentiality will be protected to the greatest extent possible. 
 
This study will be performed in accordance with Health Insurance Portability and Accountability 
Act.  These guidelines will be followed specifically with regard to the privacy and confidentiality 
of patient care and study records.  Personnel associated with Investigator’s office, the U.S. Food 
and Drug Administration (FDA) and the governing Institutional Review Board, have the right to 
review the data, including photographs, collected during this study.   
 
 

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14. Biostatistics:  
This initial study will include descriptive statistics from baseline analysis. 
 
Mean change from baseline will be used to calculate data obtained from transepidermal water 
loss, high resolution ultrasonography, 3D photography, optical coherence tomography, and/or 
BTC 2000 measurements, and biopsies. 
 
The primary outcome measure of effectiveness will be a paired comparison of baseline to 
immediate, 3-month, and 6-month follow-up ratings for improvement in skin tone, texture, and 
pore size using VISIA, depression using Miravex 3D imaging, as well as data obtained from high 
resolution ultrasonography, 3D photography, optical coherence tomography, and/or BTC 2000 
measurements, and biopsy.  The “downtime” will be measured by a trans-epidermal water loss 
assessment of re-epithelialization. Safety will be defined as an absence of adverse events related 
to the procedure.  Photographs of treated skin at follow-up visits will be compared to baseline to 
document the healing time course and may be used for blinded scoring evaluations of skin tone, 
skin texture and pore size, as well as for subject self-assessment.  
 
15. References 
1. Goodman GJ, Baron JA. Postacne scarring—a quantitative global scarring grading 
system. J Cosmet Dermatol. 2006;5:48-52. 
2. El-Domyati M, Barakat M, Awad S, et al. Microneedling therapy for atrophic acne scars: 
an objective evaluation. J Clin Aesthet Dermatol. 2015;8:36-42. 
3. Soliman, Y. S., Horowitz, R., Hashim, P. W., Nia, J. K., Farberg, A. S., & Goldenberg, 
G. (2018). Update on acne scar treatment. Cutis, 102(1), 21. 
4. Joseph, Max. "Handbuch der kosmetik." (1912). 
5. Miller, Charles Conrad. Connula Implants and Review of Implatation Technics in 
Esthetic Surgery. Oak Press, 1926. 
6. Coleman, Sydney R. "Structural fat grafting: more than a permanent filler." Plastic and 
reconstructive surgery 118, no. 3S (2006): 108S-120S. 
7. Azzam, O. A., Atta, A. T., Sobhi, R. M., & Mostafa, P. I. (2013). Fractional CO (2) laser 
treatment vs autologous fat transfer in the treatment of acne scars: a comparative 
study. Journal of drugs in dermatology: JDD, 12(1), e7-e13. 
8. Tenna, S., A. Cogliandro, M. Barone, Vincenzo Panasiti, M. Tirindelli, Carolina Nobile, 
and Paolo Persichetti. "Comparative study using autologous fat grafts plus platelet-rich 
plasma with or without fractional CO 2 laser resurfacing in treatment of acne scars: 
analysis of outcomes and satisfaction with FACE-Q." Aesthetic plastic surgery 41, no. 3 
(2017): 661-666.