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

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Topical latanoprost 0.005%
Topical betamethasone 0.05%
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring alopecia areata, betamethasone, latanoprost, topical steroid, prostaglandin

Eligibility Criteria

undefined - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Dermatology, PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topical latanoprost

Topical betamethasone

Arm Description

Topical latanoprost 0.005%

Topical betamethasone 0.05%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2015
Last Updated
November 29, 2015
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02350023
Brief Title
Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata
Acronym
COLA
Official Title
A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
alopecia areata, betamethasone, latanoprost, topical steroid, prostaglandin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical latanoprost
Arm Type
Active Comparator
Arm Description
Topical latanoprost 0.005%
Arm Title
Topical betamethasone
Arm Type
Active Comparator
Arm Description
Topical betamethasone 0.05%
Intervention Type
Drug
Intervention Name(s)
Topical latanoprost 0.005%
Intervention Description
Local application of the drug on affected skin/scalp
Intervention Type
Drug
Intervention Name(s)
Topical betamethasone 0.05%
Intervention Description
Local application of the drug on affected skin/scalp
Primary Outcome Measure Information:
Title
Number of patients with hair regrowth (complete, partial, or no regrowth)
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Number of patients suffering from adverse effects
Description
The adverse effects of the study drugs will be assessed including erythema, pruritus, skin atrophy, dermatitis, telangiectasia, and others
Time Frame
4 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dept of Dermatology, PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
33580923
Citation
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.
Results Reference
derived

Learn more about this trial

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

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