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| Name | Class |
|---|---|
| Grupo Medifarma, S. A. de C. V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional Triamcinolone | Active Comparator | A dosage of 4mg/cm2 of intralesional triamcinolone will be injected in the keloid scar every 4 weeks during 6 months. |
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| Topical Pirfenidone | Experimental | 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. |
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| Triamcinolone + Pirfenidone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Pirfenidone | Drug | Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martha Alejandra Morales-Sánchez, MD, MSc | Contact | 55387033 | 312 | mmoraless@sersalud.df.gob.mx |
| Name | Affiliation | Role |
|---|---|---|
| Martha Alejandra Morales-Sánchez, MD, MSc | Centro Dermatológico Dr. Ladislao de la Pascua | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dermatológico "Dr. Ladislao de la Pascua" | Recruiting | Mexico City | 06780 | Mexico |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone + Pirfenidone | Drug | 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. |
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| Intralesional Triamcinolone | Drug | Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. |
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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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |