Treatment of Atrophic Post Acne Scars by Fat Grafting

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Atrophic Acne Scars

Intervention / Treatment
-----------------
* Procedure: Fat Grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants<br>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 | Procedure: Fat Grafting<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 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 | 
| 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 Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne- atrophic scars - autologous fat