Back to resultsErbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
Primary Purpose
Acne Vulgaris, Scars
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional Erbium Yağ Laser
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne scars, Erbium-YAG laser, platelet-rich plasma
Eligibility 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.
Sites / Locations
- Aswan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
treated with platelet rich plasma
treated with Erbium Yag Laser
treated with both line of treatments
Outcomes
Primary Outcome Measures
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron
Grade of acne scares improvement after treatment
Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness
improvement of acne scares as evaluated by sequential photos
Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied
increase in patient satisfaction after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03933033
First Posted
April 25, 2019
Last Updated
April 27, 2019
Sponsor
Aswan University Hospital
Collaborators
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT03933033
Brief Title
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
Official Title
Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
Collaborators
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Scars
Keywords
Acne scars, Erbium-YAG laser, platelet-rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
treated with platelet rich plasma
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
treated with Erbium Yag Laser
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
treated with both line of treatments
Intervention Type
Device
Intervention Name(s)
Fractional Erbium Yağ Laser
Intervention Description
Multiple sessions of Fractional Erbium Yağ Laser
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Multiple injections of Platelet Rich Plasma
Primary Outcome Measure Information:
Title
Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron
Description
Grade of acne scares improvement after treatment
Time Frame
6 months
Title
Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness
Description
improvement of acne scares as evaluated by sequential photos
Time Frame
6 month
Title
Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied
Description
increase in patient satisfaction after treatment
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31420849
Citation
El-Taieb MA, Ibrahim HM, Hegazy EM, Ibrahim AK, Gamal AM, Nada EA. Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Ther (Heidelb). 2019 Dec;9(4):707-717. doi: 10.1007/s13555-019-00318-1. Epub 2019 Aug 16.
Results Reference
derived
Learn more about this trial
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
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