Comparison Study of Two Treatment Modalities i.e. Calcipotriol Ointment and Calcipotriol Ointment Along With Ultraviolet Phototherapy in Special Kind of Hairloss Disorder Called as Alopecia Areata

Phase 3

Completed

• Conditions: PATIENTS OF ALOPECIA AREATA WITH GOOD GENERAL CONDITION AND FREE FROM ANY MAJOR SYSTEMIC ILLNESS.

• Registration Number: CTRI/2015/11/006363
• Lead Sponsor: DEPARTMENT OF SKIN AND VD

Brief Summary

INTRODUCTION-. Alopecia areata is a hair disorder consisting of nonscarring hairloss because of autoimmune etiology. This affect individual of all age, races and gender and can involve hair of any anatomica part of body most commonly  scalp.

AIMS & OBJECTIVE- (1) To compare the two treatment modalities , topical calcipotrol (0.005%) Vs topical calcipotriol (0.005%) along                                               with NBUVB phototherapy

(2) To compare the followup improovment with these two treatments

(3) Study of side effects in both treatments

METHODOLOGY- Sample size was 60, divided them into three groups (i.e. Group A, Group B and Group C) randomly. **Group A** with 25 subjects, received Topical Calcipotriol (0.005%) Ointment, once daily While **Group B** with 25 subjects, received Topical Calcipotriol (0.005%) Ointment once daily along with narrowband ultraviolet B (NBUVB) phototherapy twice weekly while **Group C** with 10 subjects, received placebo (Topical Vaseline) once daily. Outcomes in the form of improvement in “SEVERITY OF ALOPECIA TOOL†**(SALT) scoring** clinically and signs specific to AA in **dermoscope** with **trichoscan** were pursued at 6 week and 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-27
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients of any age > 5 yrs, showing features of alopecia areata.
• Patients with a diagnosis of patch type alopecia areata or alopecia totalis.
• No evidence of regrowth present at baseline.
• Patient should be free from other modalities of treatment atleast for two weeks.

Exclusion Criteria

• Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
• Patients in whom the diagnosis of alopecia areata is in question.
• Patients with active medical conditions and other comorbid conditions like infection, eczematization that in the opinion of the investigator would alter the outcome of study evaluation.
• Patients with history or evidence of hematopoietic abnormality.
• Patients with history of immunosuppression or history of recurrent serious infections.
• History of photodermatitis or photosensitivity.
• Patients taking oral corticosteroids or applying topical corticosteroids or treatment from outside.
• Patients with allergy to any component of calcipotriol preparation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HAIR GROWTH ASSESSMENT WILL BE DONE CLINICALLY BY PHOTOGRAPH WITH "SEVERITY OF ALOPECIA AREATA TOOL" SCORING AND BY TRICOSCAN INITIALLY, AFTER 4 WEEKS AND FINALLY AFTER 12 WEEKS.	4 weeks | 12 weeks or complete resolution of alopecic lesion, whichever come first

Secondary Outcome Measures

Name	Time	Method
1. Continued hair density	2. Recurrence of lesion of alopecia.

Trial Locations

Locations (1)

Government Medical College & Sir T Hospital; 🇮🇳 Bhavnagar, GUJARAT, India

Government Medical College & Sir T Hospital

🇮🇳Bhavnagar, GUJARAT, India

CHANDRA SHEKHAR JAISWAL

Principal investigator

9425328682

shekhar_innn@yahoo.co.in