Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
Sponsor
Aswan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03933033
Collaborator
South Valley University (Other)
75
1
3
20.9
3.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Jun 1, 2017
Actual Primary Completion Date
:
Aug 31, 2018
Actual Study Completion Date
:
Feb 28, 2019
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron [6 months]
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 [6 month]
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 [6 month]
increase in patient satisfaction after treatment
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 38 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aswan University Hospital | Aswan | Egypt | 81528 |
Sponsors and Collaborators
- Aswan University Hospital
- South Valley University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Moustafa A. El Taieb,
Ass. Prof. of Dermatology, Venereology and Andrology,
Aswan University Hospital
ClinicalTrials.gov Identifier:
NCT03933033
Other Study ID Numbers:
- Erbium Yag
First Posted:
May 1, 2019
Last Update Posted:
May 1, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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,
Ass. Prof. of Dermatology, Venereology and Andrology,
Aswan University Hospital
Additional relevant MeSH terms: