| CTRI Number |
CTRI/2024/06/068841 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dexamethasone vs. tofacitinib for treating patchy hair loss in children |
|
Scientific Title of Study
|
Comparison of dexamethasone oral mini pulse therapy versus oral tofacitinib therapy in the treatment of pediatric alopecia areata: a randomized control trial |
| 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 |
Department of Dermatology Room no 8 Level 2 Block F Nehru Hospital
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
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
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878920348 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rahul Mahajan |
| Address |
Department of Dermatology Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Chandigarh India 160012 |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 5010 Level 5 Block C Department of Dermatology New OPD Post Graduate Institute of Medical Education and Research
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 Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone oral mini pulse |
Oral mini pulse of dexamethasone administered as 5 tablets of 0.5 mg (i.e.; 2.5 mg dexamethasone) on two consecutive days in a week, irrespective of age and weight for 24 weeks |
| Comparator Agent |
Oral tofacitinib |
Patients 40 kilograms will be prescribed a dose of 2.5 mg twice a day and patients over 40 kilograms will receive tofacitinib in a dose of 5 mg twice a day for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with moderate to severe alopecia areata with SALT score more than 25
2. Age between 5 to 14 years.
|
|
| ExclusionCriteria |
| Details |
1. Another type of alopecia or active inflammatory disease involving the scalp.
2. Oral or intralesional treatment that may impact alopecia areata within the last 4 weeks, and topical treatment within the last 2 weeks.
3. Patients with severe hepatic, renal or other systemic disorder, serious infections like HIV, Hepatitis B, Hepatitis C.
4. Presence of any contraindication for corticosteroids or tofacitinib.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in Severity of Alopecia Tool (SALT) score at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving 30% improvement in SALT score (SALT30 ) at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 24 |
| Proportion of patients achieving SALT50/75/90/100 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 24 |
| Percentage change from baseline in SALT score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 24 |
| Percentage change from baseline in cDLQI score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 24 |
| Incidence of adverse effects in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib) |
Week 4, 8, 12, 16, 20, 24 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Alopecia areata (AA) is an autoimmune disorder that presents as one or more patches of non-scarring loss of hair (alopecia), occurring most commonly over the scalp but can be severe enough to involve all body hair. The most accepted hypothesis in the pathogenesis of AA is of autoimmune etiology. Limited data available on efficacy and safety of oral mini pulse of corticosteroids in adults, but no randomized controlled trials have been conducted in the pediatric age group. Several case reports and case series have described successful use of tofacitinib in pediatric patients with alopecia areata without any serious adverse events. While therapeutic efficacy in the treatment of pediatric patients with severe AA in several case series, prospective and controlled trials are needed to assess the safety and efficacy of the use of oral tofacitinib in the long-term management of AA in the pediatric patient population. This study aims to compare the efficacy of oral dexamethasone mini pulse with oral tofacitinib as well as to compare the safety profile of the two drugs in pediatric alopecia areata. |