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Completed

NCT Number: NCT05887232

Comparison of Co2 Laser Versus Co2 Laser With PRP 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.

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Key information

Conditions

CO2 Laser in Scars

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr.Zahra Nigar

Abbottabad, KPK, 22010, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fractional CO2 laser

Procedure

Patient in group A received FCL treatments four sessions with four weeks apart

Fractional CO2 with Platelet Rich Plasma

Procedure

Group B received four PRP and FCL sessions 4 weeks apart

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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