Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 272 for:    Betamethasone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350023
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Sonali Bhat, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Topical latanoprost 0.005% Drug: Topical betamethasone 0.05% Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Study of Efficacy and Safety of Topical Latanoprost Versus Topical Corticosteroid in the Treatment of Localized Alopecia Areata
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


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




Primary Outcome Measures :
  1. Number of patients with hair regrowth (complete, partial, or no regrowth) [ Time Frame: 4 months ]
    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 :
  1. Number of patients suffering from adverse effects [ Time Frame: 4 months ]
    The adverse effects of the study drugs will be assessed including erythema, pruritus, skin atrophy, dermatitis, telangiectasia, and others



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350023


Locations
Layout table for location information
India
Dept of Dermatology, PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Layout table for additonal information
Responsible Party: Sonali Bhat, Dr, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02350023     History of Changes
Other Study ID Numbers: 9121/PG-2Trg/12/8073
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Sonali Bhat, Postgraduate Institute of Medical Education and Research:
alopecia areata
betamethasone
latanoprost
topical steroid
prostaglandin
Additional relevant MeSH terms:
Layout table for MeSH terms
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Latanoprost
Antihypertensive Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents