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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat Grafting | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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
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 |
| Change in patient satisfaction | The modified global aesthetic improvement scale for patient evaluation module which consists of 5 degrees
| 3 Months, and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Bruising Status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahaf Alkhouli, MSc | Dermatology Department, University of Damascus Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology and Venereology Hospital | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21880356 | Background | 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. | |
| 10468803 | Background | 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. |
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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 |
| 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 |
| 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 |
| Change in Irregularity Presence | Patients will be examined after procedure to check irregularity presence at the end of the study | Baseline and 6 Months |
| 30856634 | Background | 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. |
| 19376456 | Background | 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. |
| 11304456 | Background | 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. |
| 17085224 | Background | 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. |
| 22745443 | Background | 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. |
| 26038369 | Background | 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. |
| 23783059 | Background | 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. |
| 17199653 | Background | 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. |
| 29914257 | Background | 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. |