Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars

NCT05887232 | Completed Phase 1

• 1 other identifier: CMHAbbottabad1988
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CO2 Laser in Scars

Outcome Measures

Primary Outcomes (1)

• Quartile grading scale for assessment of scars

  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

Study Arms (2)

Fractional Co2 laser

ACTIVE COMPARATOR

Patient in group A received FCL treatment's four sessions four weeks apart.

Procedure: Fractional CO2 laser

Platelet Rich Plasma

ACTIVE COMPARATOR

Group B received fractional CO2 with four Platelet Rich Plasma sessions,4 weeks apart.

Procedure: Fractional CO2 with Platelet Rich Plasma

Interventions

Fractional CO2 laser PROCEDURE

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

Fractional Co2 laser

Fractional CO2 with Platelet Rich Plasma PROCEDURE

Group B received four PRP and FCL sessions 4 weeks apart

Platelet Rich Plasma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Dr.Zahra Nigar

Abbottabad, KPK, 22010, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 2, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

PA (1)