NCT02798016

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

May 13, 2016

Last Update Submit

December 31, 2017

Conditions

Atrophic Acne Scars

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patients' Satisfaction

    This is going to be assessed six months following the application of the intervention and the active comparator

Study Arms (2)

Platelet-Rich Plasma alone

EXPERIMENTAL

The scars will be injected with Platelet-Rich Plasma alone.

Procedure: Platelet-Rich Plasma

Platelet-Rich Plasma with micro-needling

ACTIVE COMPARATOR

The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma

Procedure: Platelet-Rich PlasmaProcedure: Micro-needling

Interventions

Platelet-Rich PlasmaPROCEDURE

This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars

Platelet-Rich Plasma alonePlatelet-Rich Plasma with micro-needling
Micro-needlingPROCEDURE

Micro-needling will be applied on the acne scars in one side of the face.

Platelet-Rich Plasma with micro-needling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atrophic acne scars on both sides of the face

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology and Venereology

Damascus, Syrian Arab Republic, DM20AM18, Syria

Location

Related Publications (4)

  • 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.

    PMID: 7955470BACKGROUND

  • 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.

    PMID: 156054BACKGROUND

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

    PMID: 10495379BACKGROUND

  • 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.

    PMID: 18245923BACKGROUND

Study Officials

  • Faiez Al-Deghlaoui, MD MSc PhD

    Associate Professor of Dermatology and Veneology, Medical School, University of Damascus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

June 14, 2016

Study Start

October 1, 2015

Primary Completion

June 23, 2017

Study Completion

October 20, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

SY(1)