Assessing effectiveness of topical gentamicin cream in junctional and dystrophic epidermolysis bullosa
Phase 2
- Conditions
- Health Condition 1: null- Epidermolysis bullosa - Junctional and Dystrophic
- Registration Number
- CTRI/2018/08/015422
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria
1. Patients with clinical diagnosis of EB and confirmed by IHC 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 six weeks 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 <2 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome <br/ ><br>1.Frequency of healed erosions on right versus left side <br/ ><br>2.Number of erosions on right versus left side <br/ ><br>3.Number of days required for erosions to heal on right versus left side <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>2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeksTimepoint: Primary Outcome <br/ ><br>1.Frequency of healed erosions on right versus left side <br/ ><br>2.Number of erosions on right versus left side <br/ ><br>3.Number of days required for erosions to heal on right versus left side <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>2. To evaluate decrease in appearance of new blisters over frequent trauma prone sites counted weekly for 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary outcomes: <br/ ><br>1.To assess the change in expression of proteins using IF positivity before and after treatment in right versus left sideTimepoint: 12 weeks and 24 weeks