Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial
Overview
- Phase
- Phase 3
- Intervention
- Intralesional Triamcinolone
- Conditions
- Keloid
- Sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Change in Keloid Scar Assessment by Patients
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Intralesional Triamcinolone
A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months.
Intervention: Intralesional Triamcinolone
Topical Pirfenidone
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.
Intervention: Topical Pirfenidone
Triamcinolone + Pirfenidone
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.
Intervention: Triamcinolone + Pirfenidone
Outcomes
Primary Outcomes
Change in Keloid Scar Assessment by Patients
Time Frame: 0 and 24 weeks
Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Change in Keloid Scar Assessment
Time Frame: 0 and 24 weeks
Assessment using the Vancouver Scar Scale (VSS)
Secondary Outcomes
- Occurrence of adverse effects(Every 4 weeks after the beginning of the intervention up to 52 weeks)
- Quality of life of the patient(24 weeks)
- Recurrence defined as an increase size of the keloid scar at week 52(52 weeks)