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

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ClinicalTrials.gov Identifier: NCT02798016
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

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).

Condition or disease Intervention/treatment Phase
Atrophic Acne Scars Procedure: Platelet-Rich Plasma Procedure: Micro-needling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Patients' Satisfaction [ Time Frame: This is going to be assessed six months following the application of the intervention and the active comparator ]
    The assessment will be based on a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798016


Locations
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Syrian Arab Republic
Department of Dermatology and Venereology
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Study Director: Faiez Al-Deghlaoui, MD MSc PhD Associate Professor of Dermatology and Veneology, Medical School, University of Damascus

Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02798016     History of Changes
Other Study ID Numbers: UDMS-Dermat-01-2016
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical