Keloid
Conditions
Keywords
Keloid, Scar
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.
Interventions
DRUGTopical Pirfenidone
Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
DRUGTriamcinolone + Pirfenidone
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.
DRUGIntralesional Triamcinolone
Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
Sponsors
Grupo Medifarma, S. A. de C. V.
Centro Dermatológico Dr. Ladislao de la Pascua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Keloid Scar Assessment | 0 and 24 weeks | Assessment using the Vancouver Scar Scale (VSS) |
| Change in Keloid Scar Assessment by Patients | 0 and 24 weeks | Assessment using the Patient and Observer Scar Assessment Scale (POSAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Mexico
Contacts
Primary ContactMartha Alejandra Morales-Sánchez, MD, MSc
Outcome results
None listed