Effectiveness of topical amlexanox in Dystrophic epidermolysis Bullosa
Phase 2
- Conditions
- Health Condition 1: Q812- Epidermolysis bullosa dystrophica
- Registration Number
- CTRI/2021/04/033024
- Lead Sponsor
- Department of Dermatology Venereology and Leprology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <3 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.Frequency of healed erosions <br/ ><br>2.Number of erosions <br/ ><br>3.Number of days required for erosions to heal <br/ ><br>4.To compare the clinical improvement in blister healing score with visual analogue score, physician global assessment and time taken to improve <br/ ><br>5.To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 12 weeks <br/ ><br>Timepoint: 12 weeks