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

A Placebo Controlled Double- Blind Randomized Control Study To Assess The Efficacy And Safety Of Oral Losartan In The Treatment Of Recessive Dystrophic Epidermolysis Bullosa

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032642

Enrollment

Registered

2021-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q812- Epidermolysis bullosa dystrophica

Interventions

Intervention1: losartan: oral losartan tablets 0.7mg/kg/day for 2 weeks then escalated to 1.4mg/kg/day for next 22 weeks Control Intervention1: placebo: Oral placebo for losartan will be given for 24

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Mean difference in the mean EBDASI at week 24 between the losartan versus placebo groups 2. Mean difference in quality of life as measured by QOLEB at week 24 between the losartan versus placebo groups 3. Adverse events for patients with treatment 4. Mean difference in pre- and post-treatment mRNA levels of TGF-Î²1 and IL-6 in the peripheral blood mononuclear cells and the affected skin tissue (among those consenting for skin biopsy). Timepoint: 6 months	—

Measure

Time frame

1. Mean difference in the mean EBDASI at week 24 between the losartan versus placebo groups 2. Mean difference in quality of life as measured by QOLEB at week 24 between the losartan versus placebo groups 3. Adverse events for patients with treatment 4. Mean difference in pre- and post-treatment mRNA levels of TGF-Î²1 and IL-6 in the peripheral blood mononuclear cells and the affected skin tissue (among those consenting for skin biopsy). Timepoint: 6 months

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Countries

India

Contacts

Public ContactDr Rahul Mahajan

PGIMER

drrahulpgi@yahoo.com9878920348

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026