FindTrial
Sign In

To study role of Tacrolimus cream in itching in patients with recessive dystrophic epidermolysis bullosa

Pilot randomised double blinded comparative trial to evaluate the efficacy of topical tacrolimus versus placebo in the management of itch in patients with recessive dystrophic epidermolysis bullosa - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/093978
Enrollment
20
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: L138- Other specified bullous disorders

Interventions

Intervention1: Topical Tacrolimus 0.03% cream: Topical Tacrolimus 0.03% cream applied once daily for a duration of 3 months Control Intervention1: Placebo: Moisturiser applied once daily for a duratio

Sponsors

ALL INDIA INSTITUTE OF MEDICALSCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a clinical diagnosis of recessive dystrophic epidermolysis bullosa, aged over six years, and experiencing moderate to severe pruritus with a Numeric Rating Scale score greater than 3

Exclusion criteria

Exclusion criteria: 1. Patients of recessive dystrophic epidermolysis bullosa not complaining of pruritus. 2. Not willing to participate in study.

Design outcomes

Primary

MeasureTime frame
To evaluate the improvement of pruritus as determined by numeric rating scale and Leuven score for pruritus in patients with recessive dystrophic epidermolysis bullosa with the use of topical tacrolimus 0.03% for 3 months as compared to placebo. To assess the improvement in disease severity and quality of life as determined by EBDASI and EBQOL in patients with recessive dystrophic epidermolysis bullosa with the use of topical tacrolimus 0.03% for 3 months as compared to placebo Timepoint: Baseline, 4 weeks, 8 weeks and 12 weeks—

Secondary

MeasureTime frame
Determination of severity of neuropathy as determined by nerve conduction and quantitative sensory testing with its correlation with severity of pruritus in patients with recessive dystrophic epidermolysis bullosa. Quantitative assessment of pruritus related cytokines including IL-31, IL-33, IL-22, IL-4, IL-13, IL-17 and TSLP at baseline and at 3 months in patients with recessive dystrophic epidermolysis bullosaTimepoint: At the end of the study—

Countries

India

Contacts

Public ContactDr. Bhoopendra Kumar

AIIMS New Delhi

bhoopendra.aiims@gmail.com9166891582

Outcome results

None listed

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