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A study comparing two CO2 laser and steroid injection treatments to improve keloid scars

Evaluating The Efficacy and Safety of CO2 Laser-Assisted Drug Delivery of Pirfenidone Combined with Intralesional Triamcinolone Acetonide (ILTAC) Versus CO2 Laser With ILTAC Alone in Keloid. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098067
Enrollment
40
Registered
2025-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L910- Hypertrophic scar

Interventions

Intervention1: Fractional CO2 laser assisted delivery of 8 percent pirfenidone gel combined with intralesional triamcinolone acetonide.: Fractional CO2 laser treatment will be performed in DEEP FX mod

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender aged 15 60 years with clinically diagnosed keloids measuring 2 10 cm in largest diameter, who are treatment-na ve and have stable lesions for at least 6 months, located on the trunk, extremities, or neck.

Exclusion criteria

Exclusion criteria: 1.Patients with infected keloids or coexisting inflammatory systemic skin diseases 2.Unrealistic expectations or psychiatric illnesses 3.Pre existing bleeding disorders 4.Lactating/pregnant patients

Design outcomes

Primary

MeasureTime frame
To compare keloid volume change from baseline to end of treatment between CO2 laser-assisted topical pirfenidone gel with ILTAC and CO2 laser with ILTAC alone using Antera 3D volumetric measurementsTimepoint: After week 24

Secondary

MeasureTime frame
changes in scar texture parameters (roughness and height), hemoglobin and melanin indices measured by Antera 3D, and recurrence monitoring through volumetric and chromophore analysis at follow-up. Additional assessments include clinician-rated Vancouver Scar Scale and POSAS observer scores, patient-reported POSAS, visual analogue scales for itch and pain, and satisfaction Likert scores. Safety endpoints include incidence and severity of corticosteroid-related effects (atrophy, telangiectasia, hypopigmentation, pain) and local pirfenidone reactions (erythema, burning, pruritus), documented throughout treatment and follow-upTimepoint: After week 24

Countries

India

Contacts

Public ContactDr Madura C

CUTIS Academy of Cutaneous Sciences

maduradr@gmail.com9632741998

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026