Skip to main content
OpenTrials
Completed

NCT Number: NCT05028283

Treatment of Atrophic Post Acne Scars by Fat Grafting

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrophic Acne Scars

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology and Venereology Hospital

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. • 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2021
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.