Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata

Phase 4

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Topical latanoprost 0.005%; Drug: Topical betamethasone 0.05%

• Registration Number: NCT02350023
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. The two agents have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

Detailed Description

Alopecia areata (AA) is an autoimmune disease that involves the hair follicles. Topical corticosteroids are the established agents for treating this disorder. Topical prostaglandins like latanoprost have also been used for this disorder. There are several case reports and case series which have demonstrated the efficacy of topical prostaglandins. However, the two agents i.e. topical corticosteroids and topical latanoprost have not been compared head-to-head in the published literature. The investigators attempt to compare the efficacy and safety of topical betamethasone and topical latanoprost in the treatment of localised alopecia areata.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-24
• Study First Posted: 2015-01-29
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-29
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• • Cases of AA involving scalp and beard area, having 5 or less patches in all, involving less than 40% area

  • Stable disease without appearance of new patch or increase in size of existing patch for at least 15 days

Exclusion Criteria

• • Pregnant and lactating women

  • Patients on topical treatment for alopecia in the past fifteen days or on systemic treatment for alopecia in the past one month
  • Presence of any contraindication for topical corticosteroids (local skin infections, skin atrophy) or latanoprost (pregnancy, lactation and dermatitis)
  • Any other coexisting hair disorder (viz., trichotillomania, androgenetic alopecia, telogen effluvium)
  • Extensive disease i.e. >5 patches of AA or area involving >40% area / alopecia totalis/ alopecia universalis/ ophiasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical latanoprost	Topical latanoprost 0.005%	Topical latanoprost 0.005%
Topical betamethasone	Topical betamethasone 0.05%	Topical betamethasone 0.05%

Primary Outcome Measures

Name	Time	Method
Number of patients with hair regrowth (complete, partial, or no regrowth)	4 months	Response to the treatment in terms of hair regrowth will be assessed. The reduction in the area affected by alopecia areata will be assessed for each patient

Secondary Outcome Measures

Name	Time	Method
Number of patients suffering from adverse effects	4 months	The adverse effects of the study drugs will be assessed including erythema, pruritus, skin atrophy, dermatitis, telangiectasia, and others

Trial Locations

Locations (1)

Dept of Dermatology, PGIMER; 🇮🇳 Chandigarh, India