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

Alopecia Areata Clinical Trial

— COLA  

Official title:

A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350023
• Other study ID #: 9121/PG-2Trg/12/8073
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2015
• Last updated: November 29, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Topical latanoprost 0.005%
Local application of the drug on affected skin/scalp
• Topical betamethasone 0.05%
Local application of the drug on affected skin/scalp

Locations

Country	Name	City	State
India	Dept of Dermatology, PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with hair regrowth (complete, partial, or no regrowth)	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	4 months	Yes
Secondary	Number of patients suffering from adverse effects	The adverse effects of the study drugs will be assessed including erythema, pruritus, skin atrophy, dermatitis, telangiectasia, and others	4 months	Yes