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

Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Atrophic Acne Scar
• Intervention / Treatment: Combination product: Fractional laser with PRP fluid or PRP gel

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • kasr Al Ainy Hospital
    • Contact: Yasmin A El Hadidy, MB BCh; Phone Number: 01142479792; Email: yasmin_ahmed_92@yashoo.com
    • Contact: Heba A Abd El Kader, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fractional laser with PRP fluid; Fractional CO2 laser then the PRP is injected afterwards	Combination product: Fractional laser with PRP fluid or PRP gel; 20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel
Active Comparator: Fractional laser with PRP gel; Fractional CO2 laser then the PRP gel is injected afterwards	Combination product: Fractional laser with PRP fluid or PRP gel; 20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel	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	one year

Collaborators and Investigators

• Sponsor: Yasmine Ahmed Abd El-Maguid El-Hadidy

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: Kasr El Aini Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No