To check for effectiveness of Losartan in patients with Dystrophic Epidermolysis Bullosa (DEB)
- Conditions
- Health Condition 1: Q812- Epidermolysis bullosa dystrophica
- Registration Number
- CTRI/2021/09/036619
- Lead Sponsor
- Dr Divya Gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Clinical: patients with clinical features of DEB- skin fragility, spontaneous onset blistering since birth, scarring, milia, systemic involvement
Age > 5 year
Written informed consent from patient/ parents/ legal guardian
AND
Investigational: diagnosis confirmed by immunofluorescence Ag mapping (IFM) AND clinical exome sequencing
Anemia with Hb < 8 g/dl
Hypotension (defined as age-related systolic BP less than 5th percentile)
Cardiologic contra-indications- ejection fraction <35%, heart failure
Severe electrolyte imbalances (esp raised serum potassium)
Renal artery stenosis
Renal or liver impairment
Hypersensitivity to losartan or any of the excipients
Pregnancy and lactation
Currently on drugs that can interact with losartan (e.g. ACE-inhibitors, rifampicin etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of wounds, <br/ ><br>Body surface involvement (BSA) <br/ ><br>Pain measurement on Visual Analogue Scale (VAS) <br/ ><br>Pruritus measurement on Visual Analogue Scale (VAS) <br/ ><br>Physician Global Assessment (PGA) <br/ ><br>Decrease in the usage of dressings <br/ ><br>Birmingham Epidermolysis Bullosa Severity Score (BEBS) <br/ ><br>Epidermolysis bullosa Disease Activity and Scarring Index (EBDASI) <br/ ><br> instrument for scoring <br/ ><br>clinical outcome for research in EB- (iscor-EB) <br/ ><br>Timepoint: 0,3,6 and 9 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method evels of IL-6, TGF-β, Smad2, Smad 6 in the woundsTimepoint: 0 and 9 months