Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial … (NCT04559022) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
United States10 participantsStarted 2020-10-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women 18 to 50 years of age having general good health.
. Individuals deemed by the Investigator to have a significant amount acne scarring on the face and that desire correction of this condition.
. 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 (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.
. Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
. Individuals willing to sign a photography release.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subject Acne Severity Scale
Timeframe: Baseline
2
Facial Photograph Assessments- Global Aesthetic Improvement Scale
Timeframe: Month 3 and Month 6
3
Topographical Analysis of Texture
Timeframe: Baseline and 6 Months
4
Histological Analysis
Timeframe: Baseline, 3 Months and 6 Months
5
Gene Expression
Timeframe: Baseline, 3 Months and 6 Months
6
Topographical Analysis of Depressions
Timeframe: Baseline and 6 Months
Trial details
NCT IDNCT04559022
SponsorUniversity of Texas Southwestern Medical Center
. 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
. Individuals diagnosed with known allergies to general skin care products.
. Individuals who have presence of an active systemic or local skin disease that may affect wound healing.
. Individuals with sensitivity to topical lidocaine.
. Individuals who have physical or psychological conditions unacceptable to the Investigator.
. Individuals who have a recent history of significant trauma to the areas to be treated (\< 6 months).
. 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.
. Individuals who have a recent or current history of inflammatory skin disease, infection, unhealed wound or clinically significant acne in the proposed treatment areas.
. 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.).