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Atrophic Acne ScarsNCT05028283

Treatment of Atrophic Post Acne Scars by Fat Grafting

A study testing Fat Grafting in people with Atrophic Acne Scars, run by Damascus University at 1 site in Syria.

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 by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Atrophic Acne Scars
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
69 participants
Where
1 siteSyria
Study dates
19 Aug 2021to 20 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients with atrophic post acne scars on the cheeks, between 20 - 40 years old
  • Not to apply other treatments a month before the procedure
  • Informed consent to enter the study

Who cannot join

  • First grade of Goodman - Barron scale.
  • A systemic or associated skin disease that may affect the results of the study
  • patients with chronic consumption of nonsteroidal anti-inflammatory drugs (NSAIDs) or other non-aggregating agents.
  • Patients with acne in the acute stage
  • Pregnancy and breastfeeding
  • Tendency to form keloids

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Dermatology and Venereology Hospital

    Damascus

Other trials in Syria

About this study

Official title: Autologous Fat Cells Transfer for the Treatment of Atrophic Post Acne Scars: Clinical Trail

This single-center, clinical trial consists of a one autologous fat grafting treatment followed by1-week , 1month , 3-month and 6-month post-treatment visits in order to assess the efficacy and complications of fat grafting when used for facial atrophic acne scars on cheeks.

Read the detailed description

This investigation, pilot study will evaluate the safety and efficacy of autologous fat grafting for the treatment of atrophic acne scarring on cheeks. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural on the Goodman-Barron scale.

The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at the end of the follow-up period.

Being tested
Fat Grafting
Keywords
Acne- atrophic scars - autologous fat

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 atrophic acne scars on the cheeks

Study groups in NCT05028283
Study groupRoleWhat they receive
participantsExperimentalpatients with atrophic acne scars on the cheeks who will reviewing the dermatological clinics at the Dermatology and Venereology Hospital at least 69 patients they will be undergo fat grafting for one session and will be follow up for 6 months after the procedure
Receives: Procedure: Fat Grafting

What is being measured

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

  1. • Change in atrophic acne scars assessment

    Acne scars will be used to evaluate efficacy of treatment using the Goodman- Barron scale [which is an acne scars severity scale divided into 4 grades

    • First grade consists of hyper-or hypopigmented flat marks
    • Second grade consists of mild atrophy or hypertrophy that may not be obvious at social distances of 50 cm or greater and may be covered adequately by makeup
    • Third grade consists of moderate atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow
    • Fourth grade severe atrophic or hypertrophic scarring that is obvious at social distances of 50 cm or greater and is not covered easily by makeup or the normal shadow].

    The grade of acne scars from final visit will be compared to their baseline grade visually evaluated by the study team.

    Measured: Baseline and 6 Months

  2. Change in patient satisfaction

    The modified global aesthetic improvement scale for patient evaluation module which consists of 5 degrees

    • Exceptionally improved [The ideal result has been achieve]
    • much improved[The result is much improved but suboptimal]
    • Improved[The result is improved but an additional procedure is recommended ]
    • no difference[The result is the same when compared with the preoperative state]
    • Worse[The result is worse when compared with the preoperative state] This module will be administered 3monts and 6 months postoperatively to analyze satisfaction and aesthetic perception of the result.

    Measured: 3 Months, and 6 Months

Secondary outcomes (5)

  1. Change in Infection existence

    Patients will be examined after procedure to check existence of infection and will be monitored until it will heal.

    Measured: 1 week, 1 month, 3 months and 6 Months

  2. Change in Bruising Status

    Patients will be examined after procedure to check bruising status and will be monitored until it will disappear

    Measured: Baseline ,1 week 1 month,3 months and 6 Months

  3. Change in Erythema Presence

    Patients will be examined after procedure to check erythema presence and will be monitored until it will disappear

    Measured: Baseline ,1 week ,1 month,3 months and 6 Months

  4. Change in Swelling Status

    Patients will be examined after procedure to check swelling status and will be monitored until it will disappear

    Measured: Baseline ,1 week 1month,3 months and 6 Months

  5. Change in Irregularity Presence

    Patients will be examined after procedure to check irregularity presence at the end of the study

    Measured: Baseline and 6 Months

Timeline

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

  1. First posted31 Aug 2021
  2. Study start19 Aug 2021
  3. Primary completion19 Aug 2023
  4. Study completion20 Oct 2023

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
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028283
Sponsor's protocol ID
UDMS-Derma-01-2021
Status last verified
Oct 2023
First submitted
25 Aug 2021
Last updated
24 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Williams HC, Dellavalle RP, Garner S. Acne vulgaris. Lancet. 2012 Jan 28;379(9813):361-72. doi: 10.1016/S0140-6736(11)60321-8. Epub 2011 Aug 29.

    PubMed 21880356

  • Goulden V, McGeown CH, Cunliffe WJ. The familial risk of adult acne: a comparison between first-degree relatives of affected and unaffected individuals. Br J Dermatol. 1999 Aug;141(2):297-300. doi: 10.1046/j.1365-2133.1999.02979.x.

    PubMed 10468803

  • Boen M, Jacob C. A Review and Update of Treatment Options Using the Acne Scar Classification System. Dermatol Surg. 2019 Mar;45(3):411-422. doi: 10.1097/DSS.0000000000001765.

    PubMed 30856634

  • Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, Shalita AR, Lozada VT, Berson D, Finlay A, Goh CL, Herane MI, Kaminsky A, Kubba R, Layton A, Miyachi Y, Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N, Wolf J Jr; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009 May;60(5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.

    PubMed 19376456

  • Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

    PubMed 11304456

  • Coleman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002.

    PubMed 17085224

  • Zeltzer AA, Tonnard PL, Verpaele AM. Sharp-needle intradermal fat grafting (SNIF). Aesthet Surg J. 2012 Jul;32(5):554-61. doi: 10.1177/1090820X12445082.

    PubMed 22745443

  • Lindenblatt N, van Hulle A, Verpaele AM, Tonnard PL. The Role of Microfat Grafting in Facial Contouring. Aesthet Surg J. 2015 Sep;35(7):763-71. doi: 10.1093/asj/sjv083. Epub 2015 Jun 2.

    PubMed 26038369

  • Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.

    PubMed 23783059

  • Goodman GJ, Baron JA. Postacne scarring: a qualitative global scarring grading system. Dermatol Surg. 2006 Dec;32(12):1458-66. doi: 10.1111/j.1524-4725.2006.32354.x.

    PubMed 17199653

  • Sezgin B, Ozmen S. Fat grafting to the face with adjunctive microneedling: a simple technique with high patient satisfaction. Turk J Med Sci. 2018 Jun 14;48(3):592-601. doi: 10.3906/sag-1711-42.

    PubMed 29914257

Questions about this trial

What is this clinical trial studying?

A study testing Fat Grafting in people with Atrophic Acne Scars, run by Damascus University at 1 site in Syria.

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 3 inclusion and 6 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 24 Oct 2023. 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 Syria. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

• Change in atrophic acne scars assessment (time frame: Baseline and 6 Months). The study lists 2 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 NCT05028283, which also lists 11 linked publications.

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 24 Oct 2023.

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