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

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ClinicalTrials.gov Identifier: NCT03933033
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
South Valley University
Information provided by (Responsible Party):
Moustafa A. El Taieb, Aswan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Scars Device: Fractional Erbium Yağ Laser Procedure: Platelet Rich Plasma Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Erbium

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
Device: Fractional Erbium Yağ Laser
Multiple sessions of Fractional Erbium Yağ Laser

Procedure: Platelet Rich Plasma
Multiple injections of Platelet Rich Plasma




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03933033


Locations
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Egypt
Aswan University Hospital
Aswan, Egypt, 81528
Sponsors and Collaborators
Aswan University Hospital
South Valley University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Moustafa A. El Taieb, Ass. Prof. of Dermatology, Venereology and Andrology, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03933033     History of Changes
Other Study ID Numbers: Erbium Yag
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moustafa A. El Taieb, Aswan University Hospital:
Acne scars
Erbium-YAG laser
platelet-rich plasma
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases