Health Condition 1: Q812- Epidermolysis bullosa dystrophica
Conditions
Interventions
Intervention1: amlexanox: antiinflammatory antiallergic immunomodulator
Intervention2: Amlexanox: 5% Amlexanox BD for 12 weeks
Sponsors
Department of Dermatology Venereology and Leprology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with clinical diagnosis of dystrophic EB confirmed by IFM and/or molecular diagnosis 2. Patients will be eligible for recruitment irrespective of gender. 3. Treatment naïve patients, which have not taken any treatment in the past and not on any systemic antibiotics
Exclusion criteria
Exclusion criteria: 1. Patients who have received any treatment in the past e.g. patients on topical/systemic antibiotics etc. in the last 6 weeks 2. Patients with frank secondary bacterial infection or sepsis 3. Patients with infected wounds 4. Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To estimate the percentage increase in mean fluorescence index (MFI), and semi-quantitative intensity of fluorescence of Collagen 7 in lesional skin biopsies after application of topical amlexanox at week 12.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of healed erosions 2. Number of erosions 3. Number of days required for erosions to heal 4. To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve 5. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 12 weeks Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rahul Mahajan
PGIMER
Outcome results
None listed