Treatment of Atrophic Post Acne Scars by Fat Grafting

October 22, 2023 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Change in atrophic acne scars assessment
Time Frame: Baseline and 6 Months

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
Time Frame: 3 Months, and 6 Months

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
Time Frame: 1 week, 1 month, 3 months and 6 Months
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
Time Frame: Baseline ,1 week 1 month,3 months and 6 Months
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
Time Frame: Baseline ,1 week ,1 month,3 months and 6 Months
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
Time Frame: Baseline ,1 week 1month,3 months and 6 Months
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
Time Frame: Baseline and 6 Months
Patients will be examined after procedure to check irregularity presence at the end of the study
Baseline and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Rahaf Alkhouli, MSc, Dermatology Department, University of Damascus Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Actual)

August 19, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-Derma-01-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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