Evaluation of the efficacy of topical Gabapentin for the treatment of pruritus in patients with Epidermolysis bullosa
Phase 3
Recruiting
- Conditions
- Epidermolysis bullosa.Epidermolysis bullosa
- Registration Number
- IRCT20210822052258N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
Age equal or more than 6 years;
Histologically confirmed any three major forms of epidermolysis bullosa (EB simplex (EBS), junctional EB (JEB), and dystrophic EB (DEB))
complain of persistent pruritic lesions unresponsive to the standard treatment
Exclusion Criteria
Use of oral gabapentin
Pregnancy or lactation
Concomitant kidney, liver, blood, thyroid, and psychiatric diseases or any other systemic disease that may cause pruritus
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Itching. Timepoint: Baseline and at the end of treatment (end of 6th week). Method of measurement: Leuven_itch_scale.;Pruritic area size. Timepoint: Baseline and at the end of treatment (end of 6th week). Method of measurement: (Length × width) ÷ 2.;Erythema. Timepoint: Baseline and at the end of treatment (end of 6th week). Method of measurement: Examination: absent (0), mild (pink-1), moderate (pink to red-2), severe (red-3).
- Secondary Outcome Measures
Name Time Method