Clinical trial NCT05028283: Treatment of Atrophic Post Acne Scars by Fat Grafting
Official title: Autologous Fat Cells Transfer for the Treatment of Atrophic Post Acne Scars: Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Acne Scars
Keywords: Acne- atrophic scars - autologous fat
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: • Change in atrophic acne scars assessment
timeFrame: Baseline and 6 Months
measure: Change in patient satisfaction
timeFrame: 3 Months, and 6 Months
Secondary outcomes:
measure: Change in Infection existence
timeFrame: 1 week, 1 month, 3 months and 6 Months
measure: Change in Bruising Status
timeFrame: Baseline ,1 week 1 month,3 months and 6 Months
measure: Change in Erythema Presence
timeFrame: Baseline ,1 week ,1 month,3 months and 6 Months
measure: Change in Swelling Status
timeFrame: Baseline ,1 week 1month,3 months and 6 Months
measure: Change in Irregularity Presence
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Dermatology and Venereology Hospital
Study officials:
affiliation: Dermatology Department, University of Damascus Medical School
name: Rahaf Alkhouli, MSc
role: PRINCIPAL_INVESTIGATOR
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