FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
PGIMER Chandigarh 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  
Close