Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
- Conditions
- Keloid
- Interventions
- Registration Number
- NCT02823236
- Lead Sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 102
- Keloids size equal or major than 1 cm
- Keloids less than 5 years old
- Keloids in trunk
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical Pirfenidone 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. Intralesional Triamcinolone Intralesional Triamcinolone A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. Triamcinolone + 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.
- Primary Outcome Measures
Name Time Method Change in Keloid Scar Assessment by Patients 0 and 24 weeks Assessment using the Patient and Observer Scar Assessment Scale (POSAS)
Change in Keloid Scar Assessment 0 and 24 weeks Assessment using the Vancouver Scar Scale (VSS)
- Secondary Outcome Measures
Name Time Method Recurrence defined as an increase size of the keloid scar at week 52 52 weeks Number of patients with an increase size of the keloid scar compared with the size obtained at week 24
Occurrence of adverse effects Every 4 weeks after the beginning of the intervention up to 52 weeks Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Quality of life of the patient 24 weeks Dermatology Life Quality Index
Trial Locations
- Locations (1)
Centro Dermatológico "Dr. Ladislao de la Pascua"
🇲🇽Mexico City, Mexico