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

Primary Purpose

Atrophic Acne Scar

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Fractional laser with PRP fluid or PRP gel
Sponsored by
Yasmine Ahmed Abd El-Maguid El-Hadidy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Acne Scar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kasr Al Ainy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fractional laser with PRP fluid

Fractional laser with PRP gel

Arm Description

Fractional CO2 laser then the PRP is injected afterwards

Fractional CO2 laser then the PRP gel is injected afterwards

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2020
Last Updated
October 7, 2020
Sponsor
Yasmine Ahmed Abd El-Maguid El-Hadidy
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1. Study Identification

Unique Protocol Identification Number
NCT04580758
Brief Title
Fractional CO2 Laser Combined With PRP Fluid Versus Gel in Treatment of Acne Scars
Acronym
PRP
Official Title
Fractional CO2 Laser Combined With Platelet Rich Plasma Fluid Versus Gel Form in Treatment of Atrophic Acne Scars: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasmine Ahmed Abd El-Maguid El-Hadidy

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fractional laser with PRP fluid
Arm Type
Active Comparator
Arm Description
Fractional CO2 laser then the PRP is injected afterwards
Arm Title
Fractional laser with PRP gel
Arm Type
Active Comparator
Arm Description
Fractional CO2 laser then the PRP gel is injected afterwards
Intervention Type
Combination Product
Intervention Name(s)
Fractional laser with PRP fluid or PRP gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A Abd El Kader, MD
Phone
01142479792
Email
H_abdelkader2007@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heba I Gawdat
Phone
01142479792
Email
H_abdelkader2007@yahoo.com
Facility Information:
Facility Name
Kasr Al Ainy Hospital
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin A El Hadidy, MB BCh
Phone
01142479792
Email
yasmin_ahmed_92@yashoo.com
First Name & Middle Initial & Last Name & Degree
Heba A Abd El Kader, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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