Treatment of Atrophic Post Acne Scars by Fat Grafting

NCT ID: NCT05028283

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2023-10-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atrophic Acne Scars

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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participants

patients 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

Group Type EXPERIMENTAL

Fat Grafting

Intervention Type PROCEDURE

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

Interventions

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Fat Grafting

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rahaf Alkhouli, MSc

Role: PRINCIPAL_INVESTIGATOR

Dermatology Department, University of Damascus Medical School

Locations

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Dermatology and Venereology Hospital

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 21880356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10468803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30856634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19376456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11304456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17085224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22745443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26038369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23783059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17199653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29914257 (View on PubMed)

Other Identifiers

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UDMS-Derma-01-2021

Identifier Type: -

Identifier Source: org_study_id

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