| CTRI Number |
CTRI/2025/09/093978 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study role of Tacrolimus cream in itching in patients with recessive dystrophic epidermolysis bullosa |
|
Scientific Title of Study
|
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
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Neetu Bhari |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number 4070, 4th floor, Teaching Block, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9650437049 |
| Fax |
|
| Email |
drntbhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhoopendra Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number 308, Skin OPD, 3rd floor, RajKumari Amrit Kaur OPD, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9166891582 |
| Fax |
|
| Email |
bhoopendra.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bhoopendra Kumar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number 308, Skin OPD, 3rd floor, RajKumari Amrit Kaur OPD, AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9166891582 |
| Fax |
|
| Email |
bhoopendra.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICALSCIENCES |
| Address |
All India Institute of Medical Sciences New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhoopendra Kumar |
All India Institute of Medical Sciences |
Room number 308, Third floor, Skin OPD, New Raj Kumari Amrit Kaur OPD, All India Institute of Medical Sciences New Delhi, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029, India
New Delhi
DELHI |
9166891582
bhoopendra.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L138||Other specified bullous disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Moisturiser applied once daily for a duration of 3 months |
| Intervention |
Topical Tacrolimus 0.03% cream |
Topical Tacrolimus 0.03% cream applied once daily for a duration of 3 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
1. Patients of recessive dystrophic epidermolysis bullosa not complaining of pruritus.
2. Not willing to participate in study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
Baseline, 4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 bullosa |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Epidermolysis bullosa (EB) is a group of inherited skin disorders caused by mutations in genes that affect the dermal-epidermal junction, leading to fragile skin, blistering, scarring, and contractures. Itching (pruritus) is a particularly disabling symptom, especially in children with recessive dystrophic EB (RDEB), worsening the condition by causing more blisters and erosions. This study aims to evaluate the effectiveness of topical tacrolimus in managing pruritus in RDEB patients, with the goal of improving patient outcomes and quality of life. |