Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars

May 31, 2023 updated by: Zahra Nigar, Combined Military Hospital Abbottabad

Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars

Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.

Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.

Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Abbottabad, KPK, Pakistan, 22010
        • Dr.Zahra Nigar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-50 years
  • Fitzpatrick skin type III-V
  • Presented with post-acne, post traumatic or post burn scars
  • all those patients emotionally balanced with realistic expectations were included in the study.

Exclusion Criteria:

  • scar that was less than 6 months old
  • if they had an active infection or inflammatory skin condition
  • having a history of malignancy
  • a known connective tissue illness
  • history of excessive bleeding or keloids
  • unrealistic expectations
  • pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fractional Co2 laser
Patient in group A received FCL treatment's four sessions four weeks apart.
Procedure: Fractional CO2 laser
Patient in group A received FCL treatments four sessions with four weeks apart
Active Comparator: Platelet Rich Plasma
Group B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart.
Procedure: Fractional CO2 with Platelet Rich Plasma
Group B received four PRP and FCL sessions 4 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quartile grading scale for assessment of scars
Time Frame: 16 weeks
Quartile grading scale was used to assess effectiveness of CO2 laser and CO2 laser with Platelet rich plasma in scars.Minimum score=0,Maximum Score=3 .Maximum score means better outcome.The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital Abbottabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CMHAbbottabad1988

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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