Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars

Overview

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.

Full Title of Study: “Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 30, 2023

Interventions

• Procedure: Fractional CO2 laser
  • Patient in group A received FCL treatments four sessions with four weeks apart
• Procedure: Fractional CO2 with Platelet Rich Plasma
  • Group B received four PRP and FCL sessions 4 weeks apart

Arms, Groups and Cohorts

• Active Comparator: Fractional Co2 laser
  • Patient in group A received FCL treatment’s four sessions four weeks apart.
• Active Comparator: Platelet Rich Plasma
  • Group B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart.

Clinical Trial Outcome Measures

Primary Measures

• 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Combined Military Hospital Abbottabad
• Provider of Information About this Clinical Study
  • Principal Investigator: Zahra Nigar, Principle Investigator – Combined Military Hospital Abbottabad