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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Topical latanoprost 0.005%
* Drug: Topical betamethasone 0.05%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical latanoprost<br>Topical latanoprost 0.005% | Drug: Topical latanoprost 0.005%<br>* Local application of the drug on affected skin/scalp<br>|
| Active Comparator: Topical betamethasone<br>Topical betamethasone 0.05% | Drug: Topical betamethasone 0.05%<br>* Local application of the drug on affected skin/scalp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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latanoprost, alopecia areata, betamethasone, topical steroid, prostaglandin