Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars

Early Phase 1

• Conditions: Atrophic Acne Scar
• Interventions: Combination Product: Fractional laser with PRP fluid or PRP gel

• Registration Number: NCT04580758
• Lead Sponsor: Yasmine Ahmed Abd El-Maguid El-Hadidy

Brief Summary

This study is to test the efficacy of fractional laser combined with either PRP fluid or PRP gel in the treatment of atrophic acne scars

Detailed Description

The study will include 20 patients, treated with fractional CO2 laser plus PRP fluid on one side of the face and fractional CO2 laser plus PRP gel on the other side.

Choosing which side of the face will be injected with PRP fluid and which side will be injected with PRP gel will be chosen according to a randomization table for each patient.

Study Timeline

• Study Start: 2020-02-25
• Status Verified: 2020-09
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age above 18
• Both genders
• Skin types III - V
• Willingness and ability to comply with the requirements of the protocol
• Atrophic acne scars

Exclusion Criteria

• Patients with active acne
• Patients with herpes labialis, bacterial infections, other infections such as HBV. HCV or HIV.
• Oral isotretinoin use in the previous 6 months
• Pregnancy
• Tendency to keloid formation
• Patients with severe systemic illness or malignancy
• Patients with connective tissue diseases
• Patients with bleeding tendencies or any other hematological disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional laser with PRP gel	Fractional laser with PRP fluid or PRP gel	Fractional CO2 laser then the PRP gel is injected afterwards
Fractional laser with PRP fluid	Fractional laser with PRP fluid or PRP gel	Fractional CO2 laser then the PRP is injected afterwards

Primary Outcome Measures

Name	Time	Method
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel	one year	Effectiveness of each combination will be measured with OCT, depth of a fixed scar on each side of the face will be measured at baseline and then compared with 1 month after the last session and 3 months after the last session

Trial Locations

Locations (1)

Kasr Al Ainy Hospital; 🇪🇬 Giza, Egypt