Treatment of Atrophic Post Acne Scars by Fat Grafting

Atrophic Acne Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028283
• Other study ID #: UDMS-Derma-01-2021
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 20, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophic Acne Scars
• Atrophy

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Syrian Arab Republic	Dermatology and Venereology Hospital	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2012 Jan 28;379(9813):314. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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.	Baseline and 6 Months
Primary	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.	3 Months, and 6 Months
Secondary	Change in Infection existence	Patients will be examined after procedure to check existence of infection and will be monitored until it will heal.	1 week, 1 month, 3 months and 6 Months
Secondary	Change in Bruising Status	Patients will be examined after procedure to check bruising status and will be monitored until it will disappear	Baseline ,1 week 1 month,3 months and 6 Months
Secondary	Change in Erythema Presence	Patients will be examined after procedure to check erythema presence and will be monitored until it will disappear	Baseline ,1 week ,1 month,3 months and 6 Months
Secondary	Change in Swelling Status	Patients will be examined after procedure to check swelling status and will be monitored until it will disappear	Baseline ,1 week 1month,3 months and 6 Months
Secondary	Change in Irregularity Presence	Patients will be examined after procedure to check irregularity presence at the end of the study	Baseline and 6 Months