| CTRI Number |
CTRI/2025/12/099514 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see whether adding a new injection to standard treatment improves skin symptoms in children with congenital ichthyosis |
|
Scientific Title of Study
|
A double-blind randomized controlled trial evaluating the effectiveness and safety of oral acitretin versus oral acitretin plus ustekinumab in non-syndromic congenital ichthyosis. |
| 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 Rahul Mahajan |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878920348 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Mahajan |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878920348 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Mahajan |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878920348 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan
P.O. Box No. 4911
Ansari Nagar
New Delhi – 110029
India |
| Type of Sponsor |
Government funding agency |
|
|
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 Rahul Mahajan |
Post Graduate Institute of Medical Education and Research |
Room no 5010 Department of Dermatology Block C New OPD Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh
Chandigarh
CHANDIGARH |
9878920348
drrahulpgi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Chandigarh, Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Acitretin |
Oral acitretin (0.5 mg/kg/day) for 24 weeks |
| Intervention |
Oral Acitretin + Ustekinumab Injection |
Oral acitretin (0.5 mg/kg/day) for 24 weeks plus ustekinumab administered subcutaneously at 0.75 mg/kg (less than 60 kg), 45 mg (60–100 kg) or 90 mg (more than 100 kg) at Weeks 0, 4, 12, and 20 |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 6 years with genetically or clinically confirmed non syndromic congenital ichthyosis or netherton syndrome will be included |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will include syndromic ichthyosis, common ichthyosis (XLRI/ichthyosis vulgaris), recent use of systemic retinoids (within 8 weeks) or biologics (within 12 weeks), active infection, significant hepatic/renal dysfunction, uncontrolled hyperlipidemia, pregnancy/lactation, or contraindications to study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean absolute change in ichthyosis area severity index (IASI) |
Baseline and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Visual Index for Ichthyosis Severity |
Weeks 0, 4, 8, 12, 20, and 24 |
| Proportion achieving more than or equal to 50% reduction in IASI |
Week 24 |
| Incidence of adverse events |
Weeks 4, 8, 12, 20, and 24 |
| Mean change in serum IL-23 and other IL-23/Th17 related cytokines |
Baseline and Week 24 |
| Change in relative mRNA expression levels of IL-23 |
Baseline and Week 24 |
| Association between gene polymorphisms (Cdx2 and Fok1 polymorphisms) and clinical response (more than or equal to 50% reduction in IASI). |
Week 24 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will compare two treatments for children with non syndromic congenital ichthyosis. One group will receive oral acitretin which is the standard treatment. The other group will receive oral acitretin plus ustekinumab injection. The aim is to find out whether adding ustekinumab gives better improvement in skin scaling and dryness. The study will run for 24 weeks. Children will be checked at regular visits and blood tests will be done to monitor safety and to study changes in inflammation markers. Participation is voluntary and all study related tests and medicines will be provided free of cost. The information from this study may help improve treatment options for children with ichthyosis in the future. |