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

NCT02350023 | Completed Phase 4

• 1 other identifier: 9121/PG-2Trg/12/8073
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

alopecia areata; betamethasone; latanoprost; topical steroid; prostaglandin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of patients suffering from adverse effects

  4 months

Study Arms (2)

Topical latanoprost

ACTIVE COMPARATOR

Topical latanoprost 0.005%

Drug: Topical latanoprost 0.005%

Topical betamethasone

ACTIVE COMPARATOR

Topical betamethasone 0.05%

Drug: Topical betamethasone 0.05%

Interventions

Topical latanoprost 0.005% DRUG

Local application of the drug on affected skin/scalp

Topical latanoprost

Topical betamethasone 0.05% DRUG

Local application of the drug on affected skin/scalp

Topical betamethasone

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dept of Dermatology, PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

• Bhat S, Handa S, De D. A randomized comparative study of the efficacy of topical latanoprost versus topical betamethasone diproprionate lotion in the treatment of localized alopecia areata. Indian J Dermatol Venereol Leprol. 2021 Jan-Feb;87(1):42-48. doi: 10.25259/IJDVL_787_19.

  PMID: 33580923 DERIVED

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 29, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

IN (1)