Back to resultsTreatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
Primary Purpose
Atrophic Acne Scars
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Platelet-Rich Plasma
Micro-needling
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Acne Scars
Eligibility Criteria
Inclusion Criteria:
- Atrophic acne scars on both sides of the face
Exclusion Criteria:
- patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
- systemic retinoids intake in the previous 6 months,
- diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
- patients on anticoagulant therapy or aspirin or have a coagulation issue,
- patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
- any previous procedures for acne scar within the last 6 months
Sites / Locations
- Department of Dermatology and Venereology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet-Rich Plasma alone
Platelet-Rich Plasma with micro-needling
Arm Description
The scars will be injected with Platelet-Rich Plasma alone.
The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma
Outcomes
Primary Outcome Measures
Change in Scar Appearance
Secondary Outcome Measures
Patients' Satisfaction
The assessment will be based on a questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02798016
Brief Title
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
Official Title
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).
Detailed Description
Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.
Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-Rich Plasma alone
Arm Type
Experimental
Arm Description
The scars will be injected with Platelet-Rich Plasma alone.
Arm Title
Platelet-Rich Plasma with micro-needling
Arm Type
Active Comparator
Arm Description
The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma
Intervention Type
Procedure
Intervention Name(s)
Platelet-Rich Plasma
Intervention Description
This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars
Intervention Type
Procedure
Intervention Name(s)
Micro-needling
Intervention Description
Micro-needling will be applied on the acne scars in one side of the face.
Primary Outcome Measure Information:
Title
Change in Scar Appearance
Time Frame
Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).
Secondary Outcome Measure Information:
Title
Patients' Satisfaction
Description
The assessment will be based on a questionnaire
Time Frame
This is going to be assessed six months following the application of the intervention and the active comparator
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Atrophic acne scars on both sides of the face
Exclusion Criteria:
patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
systemic retinoids intake in the previous 6 months,
diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
patients on anticoagulant therapy or aspirin or have a coagulation issue,
patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
any previous procedures for acne scar within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiez Al-Deghlaoui, MD MSc PhD
Organizational Affiliation
Associate Professor of Dermatology and Veneology, Medical School, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology and Venereology
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7955470
Citation
Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
Results Reference
background
PubMed Identifier
156054
Citation
Cunliffe WJ, Gould DJ. Prevalence of facial acne vulgaris in late adolescence and in adults. Br Med J. 1979 Apr 28;1(6171):1109-10. doi: 10.1136/bmj.1.6171.1109.
Results Reference
background
PubMed Identifier
10495379
Citation
Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
Results Reference
background
PubMed Identifier
18245923
Citation
Sunitha Raja V, Munirathnam Naidu E. Platelet-rich fibrin: evolution of a second-generation platelet concentrate. Indian J Dent Res. 2008 Jan-Mar;19(1):42-6. doi: 10.4103/0970-9290.38931.
Results Reference
background
Learn more about this trial
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling
We'll reach out to this number within 24 hrs