A clinical trial to study the effectiveness of pirfenidone gel with injectable steroid therapy in keloids

A comparative study between intralesional steroid and topical pirfenidone gel vs intralesional steroid monotherapy in the management of keloids : an open label randomised controlled trial in a tertiary care hospital in Eastern India - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093083

Enrollment

Registered

2025-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: Pirfenidone 8 percent gel with Intralesional Triamcinolone acetonide at 20mg per ml strength: Pirfenidone is an anti fibrotic agent that helps in the treatment of keloids by suppressing

Eligibility

Inclusion criteria

Inclusion criteria: Patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 70 years with Keloid scars previously not treated by any other methods will be included with informed consent

Exclusion criteria

Exclusion criteria: Pregnant or lactating females, patients with large Keloid scars that are unsuitable for Intralesional Steroid injections, patients treated previously, patients with bleeding disorders, keloids with secondary infection or ulceration unsuitable for intralesional injections, hypersensitivity or drug allergy to Injection Triamcinolone acetonide or topical pirfenidone 8 percent gel, unwilling patients or patients with high treatment expectations

Design outcomes

Primary

Measure	Time frame
Patients with keloids shall be randomly allotted into two groups using a computer generated randomised list. One group shall be receiving Intralesional Triamcinolone acetonide and the other group Intralesional triamcinolone with topical Pirfenidone 8 percent gel therapy. The groups will be evaluated before and after treatment based on modified Vancouver Scar Scale. Age group of the selected patients will be 18 years and above. Modified Vancouver Scar Scale is calculated for keloids based on Vascularity 0 to 3 points Pigmentation 0 to 3 points Pliability 0 to 5 points Height 0 to 3 points Pain 0 to 2 points Pruritus 0 to 2 points Total maximum score 18 pointsTimepoint: Patients will be assessed as per modified VSS on first visit with photographs followed by 3 weekly up to 12 weeks	—

Measure

Time frame

Patients with keloids shall be randomly allotted into two groups using a computer generated randomised list. One group shall be receiving Intralesional Triamcinolone acetonide and the other group Intralesional triamcinolone with topical Pirfenidone 8 percent gel therapy. The groups will be evaluated before and after treatment based on modified Vancouver Scar Scale. Age group of the selected patients will be 18 years and above. Modified Vancouver Scar Scale is calculated for keloids based on Vascularity 0 to 3 points Pigmentation 0 to 3 points Pliability 0 to 5 points Height 0 to 3 points Pain 0 to 2 points Pruritus 0 to 2 points Total maximum score 18 pointsTimepoint: Patients will be assessed as per modified VSS on first visit with photographs followed by 3 weekly up to 12 weeks

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactSubhamoy Neogi

Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata

neocnmc05@gmail.com9432848942

Outcome results

None listed

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