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).

Phase 2

Completed

• Conditions: Alopecia areata, unspecified,

• Registration Number: CTRI/2019/01/017202
• Lead Sponsor: Shibashis Chatterjee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-25
• Study Completion: 2020-06-30
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

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

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Patients who are k/c/o hypertension.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the drugs	3 months

Secondary Outcome Measures

Name	Time	Method
Therapeutic efficacy of the drugs	3 months

Trial Locations

Locations (1)

Kalinga Institute of Medical Sciences and PBM Hospital; 🇮🇳 Khordha, ORISSA, India

Kalinga Institute of Medical Sciences and PBM Hospital

🇮🇳Khordha, ORISSA, India

Shibashis Chatterjee

Principal investigator

8017642347

shibashischatt@gmail.com