NCT04580758

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

September 28, 2020

Last Update Submit

October 7, 2020

Conditions

Atrophic Acne Scar

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Fractional laser with PRP fluid

ACTIVE COMPARATOR

Fractional CO2 laser then the PRP is injected afterwards

Combination Product: Fractional laser with PRP fluid or PRP gel

Fractional laser with PRP gel

ACTIVE COMPARATOR

Fractional CO2 laser then the PRP gel is injected afterwards

Combination Product: Fractional laser with PRP fluid or PRP gel

Interventions

Fractional laser with PRP fluid or PRP gelCOMBINATION_PRODUCT

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

Fractional laser with PRP fluidFractional laser with PRP gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al Ainy Hospital

Giza, Egypt

RECRUITING

Central Study Contacts

Heba A Abd El Kader, MD

CONTACT

01142479792H_abdelkader2007@yahoo.com

Heba I Gawdat

CONTACT

01142479792H_abdelkader2007@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dermatology Resident

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 8, 2020

Study Start

February 25, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

October 8, 2020

Record last verified: 2020-09

Locations

EG(1)