NCT03933033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

April 25, 2019

Last Update Submit

April 27, 2019

Conditions

Keywords

Acne scarsErbium-YAG laserplatelet-rich plasma

Outcome Measures

Primary Outcomes (3)

  • Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron

    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

    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

    increase in patient satisfaction after treatment

    6 month

Study Arms (3)

Group A

ACTIVE COMPARATOR

treated with platelet rich plasma

Procedure: Platelet Rich Plasma

Group B

ACTIVE COMPARATOR

treated with Erbium Yag Laser

Device: Fractional Erbium Yağ Laser

Group C

ACTIVE COMPARATOR

treated with both line of treatments

Device: Fractional Erbium Yağ LaserProcedure: Platelet Rich Plasma

Interventions

Multiple sessions of Fractional Erbium Yağ Laser

Group BGroup C

Multiple injections of Platelet Rich Plasma

Group AGroup C

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acne VulgarisCicatrix

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. of Dermatology, Venereology and Andrology

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 1, 2019

Study Start

June 1, 2017

Primary Completion

August 31, 2018

Study Completion

February 28, 2019

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations