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

Sponsor

Yasmine Ahmed Abd El-Maguid El-Hadidy (Other)

Overall Status

Recruiting

CT.gov ID

NCT04580758

Collaborator

(none)

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrophic Acne Scar	Combination Product: Fractional laser with PRP fluid or PRP gel	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 25, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jan 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Al Ainy Hospital	Giza		Egypt

Sponsors and Collaborators

Yasmine Ahmed Abd El-Maguid El-Hadidy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasmine Ahmed Abd El-Maguid El-Hadidy, Dermatology Resident, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT04580758

Other Study ID Numbers:

Kasr El Aini Hospital

First Posted:

Oct 8, 2020

Last Update Posted:

Oct 8, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Oct 8, 2020