Comparison of Co2 Laser Versus Co2 Laser With PRP in Scars

NCT ID: NCT05887232

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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CO2 Laser in Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional Co2 laser

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

Group Type ACTIVE_COMPARATOR

Fractional CO2 laser

Intervention Type PROCEDURE

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

Platelet Rich Plasma

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

Group Type ACTIVE_COMPARATOR

Fractional CO2 with Platelet Rich Plasma

Intervention Type PROCEDURE

Group B received four PRP and FCL sessions 4 weeks apart

Interventions

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Fractional CO2 laser

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

Intervention Type PROCEDURE

Fractional CO2 with Platelet Rich Plasma

Group B received four PRP and FCL sessions 4 weeks apart

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital Abbottabad

OTHER

Sponsor Role lead

Responsible Party

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Zahra Nigar

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr.Zahra Nigar

Abbottabad, KPK, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CMHAbbottabad1988

Identifier Type: -

Identifier Source: org_study_id

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