Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata (COLA)

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Topical latanoprost 0.005%; Drug: Topical betamethasone 0.05%

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Dept of Dermatology, PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 97 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical latanoprost; Topical latanoprost 0.005%	Drug: Topical latanoprost 0.005%; Local application of the drug on affected skin/scalp
Active Comparator: Topical betamethasone; Topical betamethasone 0.05%	Drug: Topical betamethasone 0.05%; Local application of the drug on affected skin/scalp

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 24, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 29, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: prostaglandin; betamethasone; alopecia areata; topical steroid; latanoprost
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Betamethasone; Latanoprost
• Other Study ID Numbers: 9121/PG-2Trg/12/8073