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

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ClinicalTrials.gov Identifier: NCT04580758
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Yasmine Ahmed Abd El-Maguid El-Hadidy, Kasr El Aini Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 25, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

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




Primary Outcome Measures :
  1. Test which combination is more effective, fractional laser with PRP fluid or fractional laser with PRP gel [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580758


Contacts
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Contact: Heba A Abd El Kader, MD 01142479792 H_abdelkader2007@yahoo.com
Contact: Heba I Gawdat 01142479792 H_abdelkader2007@yahoo.com

Locations
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Egypt
Kasr Al Ainy Hospital Recruiting
Giza, Egypt
Contact: Yasmin A El Hadidy, MB BCh    01142479792    yasmin_ahmed_92@yashoo.com   
Contact: Heba A Abd El Kader, MD         
Sponsors and Collaborators
Yasmine Ahmed Abd El-Maguid El-Hadidy
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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: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical