Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars (LADISLAO)

Centro Dermatológico Dr. Ladislao de la Pascua

Status and phase: Unknown; Phase 3

Conditions: Keloid

Treatments: Drug: Topical Pirfenidone; Drug: Intralesional Triamcinolone; Drug: Triamcinolone + Pirfenidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02823236

90/15

Details and patient eligibility

About

The aim of the study is to assess the efficacy and safety of the combination of intralesional triamcinolone (at doses of 4mg / cm2 at intervals of 4 weeks) and topical pirfenidone 8% (every 8 hours continuously) compared with their isolated application, in the treatment of keloid scars in adults. The duration of this three-arm clinical trial will be 12 months, a 6-month period for treatment and a follow-up of 6 months to assess recurrences. The estimated number of persons to be recruited and randomized for the study is 102.

Full description

Individuals with keloid scars will be randomized to 3 arms of treatment in order to assess the efficacy of combining intralesional triamcinolone and topical pirfenidone compared with the isolated application of these drugs. The interventions will last 6 months but the individuals will be assessed monthly to determine recurrences for 6 more months. The scar size will be measure at weeks 12, 24 and 52.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Keloids size equal or major than 1 cm
• Keloids less than 5 years old
• Keloids in trunk

Exclusion criteria

• Keloid with a surgical indication
• Hypertrophic scars
• Scars after burn wounds
• Pregnancy
• Lactation
• Use of systemic chemotherapeutics or chronic use of systemic corticosteroids or immunosuppressive medication
• Known hypersensitivity for triamcinolone or pirfenidone
• Severe comorbidity not controlled
• Inflammatory acne
• Diabetes Mellitus
• Hypertension
• Renal, hepatic or respiratory failure
• Topical treatment 4 weeks before recruitment
• Previous treatment with intralesional steroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

Intralesional Triamcinolone

Active Comparator group

Description:

A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.

Treatment:

Drug: Intralesional Triamcinolone

Topical Pirfenidone

Experimental group

Description:

Dosage commensurate with scar surface to be treated. After washing and drying the affected area, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.

Treatment:

Drug: Topical Pirfenidone

Triamcinolone + Pirfenidone

Experimental group

Description:

A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Simultaneously, a thin layer of 8% pirfenidone will be applied on the scar, three times a day, for 6 months.

Treatment:

Drug: Triamcinolone + Pirfenidone