A Study to compare topical therapy(DPCP) in alopecia areata versus oral steroids

Not Applicable

Not yet recruiting

Conditions: Alopecia areata, unspecified,

Registration Number: CTRI/2018/10/015870

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 clinic[1](file:///E:/academics/original%20articles/Alopecia%20areata%20Rahul%20sir%20RCT/AA%20DPCPvs%20OMP%20for%20ethics%20CLr.docx#_ENREF_1 "Tan, 2002 #45") and 60% of cases occuring below 20years.1The 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.6,7,8Drawbacks 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Patients with severe non progressive alopecia areata with SALT score more than 40 and age less than 18 years.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in SALT score from baseline in both the groups.	o months, 1 month, 2 months, 3 months, 4 months, 5 months, and at 6 months
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 Measures

Name	Time	Method
Number of adverse effects in group A versus group B	24weeks

Trial Locations

Locations (1): PGIMER Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Dr Rahul Mahajan
Principal investigator
01722756562
drrahulpgi@yahoo.com