Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars

April 27, 2019 updated by: Moustafa A. El Taieb, Aswan University Hospital

Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial

This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Aswan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only

Exclusion Criteria:

  • patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
treated with platelet rich plasma
Procedure: Platelet Rich Plasma
Multiple injections of Platelet Rich Plasma
Active Comparator: Group B
treated with Erbium Yag Laser
Device: Fractional Erbium Yağ Laser
Multiple sessions of Fractional Erbium Yağ Laser
Active Comparator: Group C
treated with both line of treatments
Procedure: Platelet Rich Plasma
Multiple injections of Platelet Rich Plasma
Device: Fractional Erbium Yağ Laser
Multiple sessions of Fractional Erbium Yağ Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron
Time Frame: 6 months
Grade of acne scares improvement after treatment
6 months
Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness
Time Frame: 6 month
improvement of acne scares as evaluated by sequential photos
6 month
Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied
Time Frame: 6 month
increase in patient satisfaction after treatment
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Collaborators

South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 27, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 27, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erbium Yag

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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