| CTRI Number |
CTRI/2019/01/017202 [Registered on: 22/01/2019] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of the safety and therapeutic efficacy of oral steroids (betamethasone) in pulse dose and oral cyclosporine in the treatment of alopecia areata (patchy hair loss). |
|
Scientific Title of Study
|
Comparative study of the safety and therapeutic efficacy of oral cyclosporine and oral betamethasone minipulse therapy in the treatment of alopecia areata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shibashis Chatterjee |
| Designation |
Post Graduate Student |
| Affiliation |
KIMS & PBM Hospital Bhubaneswar |
| Address |
Room no 17 Department of Dermatology Venereology and Leprosy Kalinga Institute of Medical Science(KIMS) and PBM Hospital Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8017642347 |
| Fax |
|
| Email |
shibashischatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basanti Devi |
| Designation |
Professor and HOD |
| Affiliation |
KIMS & PBM Hospital Bhubaneswar |
| Address |
ROOM NO 16 Department of Dermatology Venereology and Leprosy Kalinga Institute of Medical Sciences and PBM Hospital Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9439549249 |
| Fax |
|
| Email |
basanti1953@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shibashis Chatterjee |
| Designation |
Post Graduate Student |
| Affiliation |
KIMS & PBM Hospital Bhubaneswar |
| Address |
ROOM NO 17 Department of Dermatology Venereology and Leprosy Kalinga Institute of Medical Sciences and PBM Hospital,Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8017642347 |
| Fax |
|
| Email |
shibashischatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences(KIMS) and PBM HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Shibashis Chatterjee |
| Address |
Room no 6E Block E KIMS Boys hostel,KIMS & PBM Hospital,Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shibashis Chatterjee |
Kalinga Institute of Medical Sciences and PBM Hospital |
Room no. 17 Department of Dermatology Venereology and Leprosy
Khordha
ORISSA |
8017642347
shibashischatt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kalinga Institute of Medical Sciences 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 |
Oral Betamethasone minipulse therapy |
Betamethasone oral mini-pulse 0.1mg/kg body wt./dose on two consecutive days per week for 12 weeks
|
| Comparator Agent |
Oral Cyclosporine |
Oral Cyclosporine 3-5mg/kg/day orally for 12 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients consenting for the study.
2.All the patients presenting with circumscribed patch of hair loss without any signs of inflammation or scarring,of size > 3cm in diameter.
3.Patients who have symptoms of 3 months or more duration.
4.Patients who have not taken any other modalities of treatment in the last 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are k/c/o hypertension.
2.Patients with secondary infection.
3.Pregnant and lactating females.
4.Patients with pre-existing renal and liver diseases.
5.Patients with diabetes mellitus.
6.Patients having any Autoimmune disease like SLE, Sjogren’s Syndrome,etc.
7.Patients having contraindications to the drugs used in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety of the drugs |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of the drugs |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/01/2019 |
| Date of Study Completion (India) |
30/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The diagnosis of Alopecia Areata will be established first clinically and dermoscopically.
The patients will be randomly allocated to Group A and Group B by concealment (opaque envelope). Group A will receive Oral Cyclosporine, and Group B will receive Oral Betamethasone Minipulse Therapy. After baseline investigations are done Group A will receive Cyclosporine 3-5mg/kg/day orally for 12 weeks. Group B will receive Betamethasone oral mini-pulse 0.1mg/kg body wt./dose on two consecutive days per week for 12 weeks. The dose of betamethasone will be tapered step-wise by 1 mg per dose every month once regrowth is achieved. |