Clinical trial NCT04559022: Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Official title: Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Acne
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women 18 to 50 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 (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.
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:

      * 12 months for Hyaluronic acid fillers (e.g. Restylane)
      * 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
      * 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)
      * 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.
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).

Primary outcomes:
measure: Subject Acne Severity Scale
timeFrame: Baseline
measure: Facial Photograph Assessments- Global Aesthetic Improvement Scale
timeFrame: Month 3 and Month 6
measure: Topographical Analysis of Texture
timeFrame: Baseline and 6 Months
measure: Histological Analysis
timeFrame: Baseline, 3 Months and 6 Months
measure: Gene Expression
timeFrame: Baseline, 3 Months and 6 Months
measure: Topographical Analysis of Depressions
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: Noninvasive Skin Assessments- TEWL
timeFrame: Month 3 and Month 6
measure: Noninvasive Skin Assessments- High-resolution Ultrasonography
timeFrame: Month 3 and Month 6
measure: Noninvasive Skin Assessments- Skin Deformation
timeFrame: Month 3 and Month 6
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: