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Acne Scars - Mixed Atrophic and HypertrophicNCT04559022

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

A study testing Fat Grafting in people with Acne Scars - Mixed Atrophic and Hypertrophic and Acne, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Fat Grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
30 Oct 2020to 14 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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
  • 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.
  • Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
  • 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.
  • 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.
  • 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.
  • Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
  • 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.
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

Other trials in United States

About this study

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.

Read the 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.

Being tested
Fat Grafting
Medical subject headings
Hypertrophy, Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fat GraftingProcedure or surgery

    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.

Study groups in NCT04559022
Study groupRoleWhat they receive
Fat Grafting for Acne Scar TreatmentOtherThis 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.
Receives: Procedure: Fat Grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

  2. 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.

    Measured: Month 3 and Month 6

  3. Topographical Analysis of Texture

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

    Measured: Baseline and 6 Months

  4. 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.

    Measured: Baseline, 3 Months and 6 Months

  5. 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.

    Measured: Baseline, 3 Months and 6 Months

  6. Topographical Analysis of Depressions

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

    Measured: Baseline and 6 Months

Secondary outcomes (3)

  1. Noninvasive Skin Assessments- TEWL

    Transepidermal Water Loss (TEWL) was measured at baseline and 6 months after treatment.

    Measured: Month 3 and Month 6

  2. Noninvasive Skin Assessments- High-resolution Ultrasonography

    Ultrasonography was used to measure epidermal/dermal thickness/density 3 and 6 months after treatment.

    Percent change from baseline results are reflected.

    Measured: Month 3 and Month 6

  3. Noninvasive Skin Assessments- Skin Deformation

    biomechanical analysis of skin deformation was used to measure skin laxity, skin elasticity, viscoelastic deformation, ultimate deformation, stiffness and energy absorption at 3 and 6 months after treatment.

    Percent change from baseline results are reflected.

    Measured: Month 3 and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start30 Oct 2020
  3. Primary completion10 Jun 2022
  4. Study completion14 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559022
Sponsor's protocol ID
STU 2020-0310
Status last verified
Aug 2024
First submitted
1 Sep 2020
Last updated
26 Oct 2024
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Fat Grafting in people with Acne Scars - Mixed Atrophic and Hypertrophic and Acne, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Acne Severity Scale (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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