To Assess the efficacy and safety Of Oral Losartan In The Treatment Of Recessive Dystrophic Epidermolysis Bullosa

Phase 2

• Conditions: Health Condition 1: Q812- Epidermolysis bullosa dystrophica

• Registration Number: CTRI/2021/04/032642
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Recessive dystrophic epidermolysis bullosa patients regardless of sex.

2.Patients of age 6 years and above

3.Patients who are normotensive or hypertensive (cause other than renal stenosis)

4.Patients with normal renal function, liver function and serum potassium levels.

5.Patients who can give valid consent.

6.Willing for monthly follow-up visits for at least 6 months.

Exclusion Criteria

1.Dominant dystrophic epidermolysis bullosa, epidermolysis bullosa simplex, junctional epidermolysis bullosa and kindler syndrome

2.High levels of potassium in the blood.

3.Hypotension (defined as age- related systolic blood pressure under the 5th percentile)

4.Hypersensitivity to losartan

5.Kidney impairment with eGFR less than <30ml/ min

6.Renal artery stenosis.

7.Deranged liver function tests.

8.Patients who are HBsAg, Anti HCV and HIV positive.

9.Patients who are taking medicines which are likely to cause interactions like ACE inhibitors, Rifampicin

10.Current pregnancy or nursing period

11.Inability to come for monthly follow up visits for 6 months

12.Those who donâ??t provide consent for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Proportion of patients achieving clinically significant improvement in the group receiving oral losartan versus the placebo group (defined as 9-point reduction in EBDASI)Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
1.Mean difference in the mean EBDASI at week 24 between the losartan versus placebo groups <br/ ><br>2.Mean difference in quality of life as measured by QOLEB at week 24 between the losartan versus placebo groups <br/ ><br>3.Adverse events for patients with treatment <br/ ><br>4.Mean difference in pre- and post-treatment mRNA levels of TGF-β1 and IL-6 in the peripheral blood mononuclear cells and the affected skin tissue (among those consenting for skin biopsy). <br/ ><br>Timepoint: 6 months