Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling

Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Atrophic Acne Scars
• Intervention / Treatment: Procedure: Platelet-Rich Plasma; Procedure: Micro-needling

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Dermatology and Venereology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Platelet-Rich Plasma alone; The scars will be injected with Platelet-Rich Plasma alone.	Procedure: Platelet-Rich Plasma; This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars
ACTIVE_COMPARATOR: Platelet-Rich Plasma with micro-needling; The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma	Procedure: Platelet-Rich Plasma; This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars; Procedure: Micro-needling; Micro-needling will be applied on the acne scars in one side of the face.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Scar Appearance	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 Measures

Outcome Measure	Measure Description	Time Frame
Patients' Satisfaction	The assessment will be based on a questionnaire	This is going to be assessed six months following the application of the intervention and the active comparator

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Study Director: Faiez Al-Deghlaoui, MD MSc PhD, Associate Professor of Dermatology and Veneology, Medical School, University of Damascus

Publications and helpful links

General Publications

• Goulden V, Stables GI, Cunliffe WJ. Prevalence of facial acne in adults. J Am Acad Dermatol. 1999 Oct;41(4):577-80.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): June 23, 2017
• Study Completion (ACTUAL): October 20, 2017

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (ESTIMATE): June 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: UDMS-Dermat-01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED