| CTRI Number |
CTRI/2018/10/015870 [Registered on: 01/10/2018] Trial Registered Prospectively |
| Last Modified On: |
23/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A Study to compare topical therapy(DPCP) in alopecia areata versus oral steroids |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED TRIAL TO COMPARE THE EFFECTIVENESS AND SAFETY OF LOW DOSE DEXAMETHASONE PULSE VERSUS CONTACT SENSITISATION WITH DIPHENYLCYCLOPROPENONE IN STABLE/NON PROGRESSIVE ALOPECIA AREATA IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Department of Dermatology, Venereology and Leprology PGIMER Chandigarh |
| Address |
Department of Dermatology
PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
01722756562 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rahul Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Department of Dermatology, Venereology and Leprology PGIMER Chandigarh |
| Address |
Department of Dermatology
PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
01722756562 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Rahul Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Department of Dermatology, Venereology and Leprology PGIMER Chandigarh |
| Address |
Department of Dermatology
PGIMER Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
01722756562 |
| Fax |
|
| Email |
drrahulpgi@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
PGIMER Chandigarh |
Room number 5010
New OPD, 5th floor
PGIMER Chandigarh Chandigarh CHANDIGARH |
01722756562
drrahulpgi@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, PGIMER Chandigarh |
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 |
DPCP- topical |
once weekly application half head, after sensitisation with 2% DPCP
starting with 0.001% dpcp, increasing by 10% every week till desired pruritus or erythema is reached |
| Intervention |
Oral mini pulse corticosteroids- dexamethasone |
2.5 mg twice a week, PO |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with severe non progressive alopecia areata with SALT score more than 40 and age less than 18 years. |
|
| ExclusionCriteria |
| Details |
1. Progressive AA- new lesions(more than 5 patches) in last 3 months
2. Patients with severe hepatic, renal or other systemic disorder
3. Patients experiencing spontaneous regrowth of lost hair
4. Patients of known hypersensitivity to DPCP
5. Presence of any contraindication for corticosteroids
6. Parents/Patients not giving consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in SALT score from baseline in both the groups.
2. Cosmetically acceptable hair regrowth or cosmetically unacceptable hair regrowth in both the groups
|
o months, 1 month, 2 months, 3 months, 4 months, 5 months, and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of adverse effects in group A versus group B |
24weeks |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/10/2018 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY OF PROPOSED RESEARCH Alopecia areata (AA) is an autoimmune disease that presents as patches of non-scarring alopecia, most commonly over the scalp but can be severe enough to involve all body hair. It is a common disease encountered by dermatologists, with a frequency ranging from 0.7% to 3.8% of patients attending dermatology clinic1 and 60% of cases occuring below 20years.1 The most accepted hypothesis in the pathogenesis of AA is an autoimmune etiology. Management of AA depends on the severity of the disease and age of the patient. The various therapeutic modalities employed include topical corticosteroids, intralesional corticosteroids, systemic corticosteroids, systemic immunomodulators like methotrexate and azathioprine, contact immunotherapy with squaric acid dibutyl ester and diphenyl cyclopropene, topical anthralin and psoralen plus ultraviolet A (PUVA) therapy.2 A recent Cochrane review has shown that few therapies for alopecia areata (AA) have been comprehensively evaluated in randomized controlled trials.3 AA presenting as unifocal or multifocal patches can be treated with topical/intralesional steroids. For more extensive disease systemic corticosteroids or immunotherapy may be required. Few studies have looked at therapies for this disorder in children, so much of the data are derived from adult literature and describe off-label use of medication. Topical corticosteroids are the preferred first-line therapy for pediatric alopecia areata. Several forms of systemic corticosteroids have been described in the literature with variable success rates (30-60%).4,5Various ways of administering systemic corticosteroids that have been tried in AA include alternating daily doses of oral prednisone, high dose of once monthly prednisolone, intravenous methyl- prednisolone and dexamethasone oral mini pulse (OMP) 2.5-5 mg twice weekly for a minimum period of 12 weeks.6,7,8 Drawbacks to systemic corticosteroids include their adverse effect profile and the high relapse rate after reduction of the dose necessitating a maintenance regimen to maintain the achieved hair regrowth. Corticosteroid pulse therapy seems to have less of a side effect profile than daily or alternate day oral regimens. Contact immunotherapy has also shown a promising therapy fpr extensive AA with good response rates. Benefit of using DPCP lies in the fact that the drug has very limited cutaneous side effects like irritant reaction , eczema, urticaria, with no systemic side effects. There is paucity of data in literature comparing the efficacy of oral mini pulse corticosteroids with DPCP contact sensitization. The present study is aimed to compare the efficacy of oral mini pulse corticosteroids- dexamethasone with DPCP contact sensitization and also to compare the safety profile of the two drugs in severe alopecia areata. |