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

NCT04559022 | Completed Results

• 1 other identifier: STU 2020-0310
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic; Acne

Outcome Measures

Primary Outcomes (6)

• Subject Acne Severity Scale

  The Goodman and Baron Qualitative Acne Scale will be used to assess acne scars. Grade 1- Macular Disease: Erythematous, hyper- or hypopigmented flat marks Grade 2- Mild Disease: Mild rolling, small soft papular Grade 3- Moderate Disease: More significant rolling, shallow "box car", mild to moderate hypertrophic or papular scars Garde 4- Severe disease: Punched out atrophic, "ice pick", bridges and tunnels, gross atrophy, dystrophic, scars significant hypertrophy or keloid

  Baseline

• Facial Photograph Assessments- Global Aesthetic Improvement Scale

  Subjects and Clinicians will evaluate efficacy of treatment at follow up visits. The photographs from follow up visits will be compared to their baseline photographs. Acne scars on patients will be assessed using the Global Aesthetic Improvement Scale by subject and clinician. CGAIS Rating 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.

  Month 3 and Month 6

• Topographical Analysis of Texture

  MiraVex will be used to assess changes in texture (roughness) of the subjects facial acne scars.

  Baseline and 6 Months

• Histological Analysis

  Relative changes in protein abundance in biopsies taken at post treatment compare to control or entreated group will be quantified using an image processing software based on fluorescence signal intensity. The change from baseline was calculated at each time frame.

  Baseline, 3 Months and 6 Months

• Gene Expression

  Biopsies of the treated are will be taken prior to treatment and post treatment for gene expression analysis. This analysis will identify gene expression related to collagen formation and increased cell turnover.

  Baseline, 3 Months and 6 Months

• Topographical Analysis of Depressions

  MiraVex will be used to assess changes in depressions of the subjects facial acne scars.

  Baseline and 6 Months

Secondary Outcomes (3)

• Noninvasive Skin Assessments- TEWL

  Month 3 and Month 6

• Noninvasive Skin Assessments- High-resolution Ultrasonography

  Month 3 and Month 6

• Noninvasive Skin Assessments- Skin Deformation

  Month 3 and Month 6

Study Arms (1)

Fat Grafting for Acne Scar Treatment

OTHER

This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.

Procedure: Fat Grafting

Interventions

Fat Grafting PROCEDURE

This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.

Fat Grafting for Acne Scar Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.).
• Individuals who currently have or have a history of hypertrophic scars, or keloid scars.
• Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated and/or with a history of skin cancer.
• Individuals who have the inability to understand instructions or to give informed consent.
• 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.
• Individuals who have a history of chronic drug or alcohol abuse.
• Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
• Individuals who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypertrophy; Acne Vulgaris

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Research Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

2146458907

Study Officials

• Jeffrey Kenkel, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Plastic Surgery

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 22, 2020
• Study Start: October 30, 2020
• Primary Completion: June 10, 2022
• Study Completion: December 14, 2022
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-08

Locations

US (1)