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Treatment of Atrophic Post Acne Scars by Fat Grafting

Primary Purpose

Atrophic Acne Scars

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Fat Grafting
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Acne Scars focused on measuring Acne- atrophic scars - autologous fat

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dermatology and Venereology Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

participants

Arm Description

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

Outcomes

Primary Outcome Measures

• 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.
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.

Secondary Outcome Measures

Change in Infection existence
Patients will be examined after procedure to check existence of infection and will be monitored until it will heal.
Change in Bruising Status
Patients will be examined after procedure to check bruising status and will be monitored until it will disappear
Change in Erythema Presence
Patients will be examined after procedure to check erythema presence and will be monitored until it will disappear
Change in Swelling Status
Patients will be examined after procedure to check swelling status and will be monitored until it will disappear
Change in Irregularity Presence
Patients will be examined after procedure to check irregularity presence at the end of the study

Full Information

First Posted
August 25, 2021
Last Updated
October 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05028283
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
August 19, 2023 (Actual)
Study Completion Date
October 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scars
Keywords
Acne- atrophic scars - autologous fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Fat Grafting
Intervention Description
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 Outcome Measure Information:
Title
• Change in atrophic acne scars assessment
Description
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.
Time Frame
Baseline and 6 Months
Title
Change in patient satisfaction
Description
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.
Time Frame
3 Months, and 6 Months
Secondary Outcome Measure Information:
Title
Change in Infection existence
Description
Patients will be examined after procedure to check existence of infection and will be monitored until it will heal.
Time Frame
1 week, 1 month, 3 months and 6 Months
Title
Change in Bruising Status
Description
Patients will be examined after procedure to check bruising status and will be monitored until it will disappear
Time Frame
Baseline ,1 week 1 month,3 months and 6 Months
Title
Change in Erythema Presence
Description
Patients will be examined after procedure to check erythema presence and will be monitored until it will disappear
Time Frame
Baseline ,1 week ,1 month,3 months and 6 Months
Title
Change in Swelling Status
Description
Patients will be examined after procedure to check swelling status and will be monitored until it will disappear
Time Frame
Baseline ,1 week 1month,3 months and 6 Months
Title
Change in Irregularity Presence
Description
Patients will be examined after procedure to check irregularity presence at the end of the study
Time Frame
Baseline and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahaf Alkhouli, MSc
Organizational Affiliation
Dermatology Department, University of Damascus Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology and Venereology Hospital
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21880356
Citation
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Citation
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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PubMed Identifier
30856634
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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.
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Citation
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.
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Treatment of Atrophic Post Acne Scars by Fat Grafting

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