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Effect of Intralesional Triamcinolone combined with Pentoxifylline versus Intralesional Triamcinolone alone in the treatment of Keloid

A Hospital-Based Randomized Controlled Trial comparing the Efficacy of Intralesional Triamcinolone combined with Pentoxifylline versus Intralesional Triamcinolone alone in the treatment of Keloid - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090637
Enrollment
90
Registered
2025-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: L918- Other hypertrophic disorders of the skin

Interventions

Intervention1: Intralesional Triamcinolone acetonide combined with Pentoxifylline: Intralesional Triamcinolone acetonide combined with Pentoxifylline monthly sessions for 6 months.the total duration

Sponsors

Dr Ravi Daiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 60 years. 2.Presence of clinically diagnosed keloid(s) persisting for at least 6 months. 3.Willing to adhere to the study protocol and complete follow-up assessments. 4.Keloid size between 0.5 cm and 8 cm in diameter. 5.No treatment with intralesional injections within the past 1 month.

Exclusion criteria

Exclusion criteria: 1.Active local skin infections or ulceration at the treatment site. 2.History of hypertrophic scar rather than keloid. 3.Known hypersensitivity to triamcinolone or pentoxifylline. 4.Patients with immunosuppressive or systemic corticosteroid therapy. 5.Patients with systemic illness such as uncontrolled diabetes, liver/kidney dysfunction. 6.Pregnant or lactating women. 7.Bleeding diathesis or anticoagulant use. 8.History of epilepsy, peptic ulcer, or recent myocardial infarction (contraindications for pentoxifylline). 9.Participation in another clinical trial within the last 3 months

Design outcomes

Primary

MeasureTime frame
Decrease in Vancouver Scar Scale (VSS) score Assessment of vascularity, pigmentation, pliability, and height.Timepoint: At 0, 6 and 12 months.

Secondary

MeasureTime frame
1.Percentage reduction in keloid size (surface area and thickness) 2.Global photographic assessment Standardized photos evaluation 3.Symptom evaluation Pain and pruritus assessed at every visit using Visual Analog Scale (VAS). 4.Adverse events Monitoring of both local and systemic side effects such as skin atrophy, depigmentation, ulceration, and systemic reactions (e.g., GI upset from pentoxifylline). Timepoint: for keloid size and photographic assessment- 0,6,12 months for symptoms and adverse events - every monthly visit

Countries

India

Contacts

Public ContactRavi Daiya

ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR

dr.sunil_30@yahoo.co.in9838844937

Outcome results

None listed

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