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Clinical Trials/CTRI/2025/10/095881
CTRI/2025/10/095881
Not yet recruiting
Not Applicable

An interventional prospective study to evaluate and compare the efficacy of the combination of Fractional CO2 Laser (FCL) and Intralesional Triple therapy (ILS-3) against Intralesional Triple Therapy (ILS-3) alone in the treatment of keloids.

Dr Chetan Turale1 site in 1 country38 target enrollmentStarted: November 1, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Chetan Turale
Enrollment
38
Locations
1
Primary Endpoint
Regression in the dimensions of keloid
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study is a randomized, open lable, parallel group, single centre trial evaluating and comparing the efficacy of the combination of Fractional CO2 Laser and Intralesional triple therapy against Intralesional triple therapy alone in the treatment of keloids. the primary outcome measures regression in the size of keloids every 3 weeks for first 4 sessions, followed by at 3rd and 6th month. the secondary outcome measures the regression in the symptoms associated with keloids viz. pain and pruritus from the second session.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Diagnosed cases of keloids more than 18 years of age Patients who have given informed consent.

Exclusion Criteria

  • •Patients not consenting to be a part of the study Paediatric and geriatric patients Pregnant or lactating cases Cases with obvious signs of infection over the keloid or any sign of malignancy Patient with a history of any past treatment for keloids.

Outcomes

Primary Outcomes

Regression in the dimensions of keloid

Time Frame: Every 3 weekly for 4 sessions then at 3rd month and 6th month

Secondary Outcomes

  • Regression in the associated symptoms viz pain and pruritus(after 2 sessions)

Investigators

Sponsor
Dr Chetan Turale
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Chetan Turale

Dr Vithalrao Vikhe Patil Foundations hospital Ahmadnagar

Study Sites (1)

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