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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars: 3-arm Trial

Conditions
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Keloid

Intervention / Treatment
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* Drug: Topical Pirfenidone
* Drug: Triamcinolone + Pirfenidone
* Drug: Intralesional Triamcinolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralesional Triamcinolone<br>A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. | Drug: Intralesional Triamcinolone<br>* Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.<br>* Other names: Kenalog;|
| Experimental: Topical Pirfenidone<br>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. | Drug: Topical Pirfenidone<br>* Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.<br>* Other names: KitosCell;|
| Experimental: Triamcinolone + Pirfenidone<br>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. | Drug: Triamcinolone + Pirfenidone<br>* Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.<br>* Other names: Kenalog + KitosCell;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Keloid Scar Assessment | Assessment using the Vancouver Scar Scale (VSS) | 0 and 24 weeks | 
| Change in Keloid Scar Assessment by Patients | Assessment using the Patient and Observer Scar Assessment Scale (POSAS) | 0 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse effects | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Every 4 weeks after the beginning of the intervention up to 52 weeks | 
| Quality of life of the patient | Dermatology Life Quality Index | 24 weeks | 
| Recurrence defined as an increase size of the keloid scar at week 52 | Number of patients with an increase size of the keloid scar compared with the size obtained at week 24 | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloid, Scar