Working… Menu

Topical Bimatoprost Solution 0.03%in Stable Vitiligo

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. Identifier: NCT01202513
Recruitment Status : Withdrawn (regulatory reasons)
First Posted : September 16, 2010
Last Update Posted : August 3, 2011
Information provided by:
Gian Sagar Medical College and Hospital

Brief Summary:

Vitiligo is an acquired depigmentation disorder of great cosmetic importance, affecting 1-4% of the world's population. Phototherapy and topical agents such as corticosteroids, calcineurin inhibitors, and vitamin-D derivatives are basic treatment modalities have been used in vitiligo but there is still no effective and safe treatment for this disease. Resistance to therapy, treatment complications and recurrence after treatment are the major problems of the current treatments.

There are no clinical studies of use of Bimatoprost in treatment of vitiligo, as it is supposed to cause more hyperpigmentation and hypertrichosis as compared to other topical prostaglandin analogues; hence, the investigators decided to use it in treatment of localized vitiligo.

Condition or disease Intervention/treatment Phase
Vitiligo Repigmentation Drug: Bimatoprost 0.03% topical ophthalmic solution Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Bimatoprost Solution 0.03% in Stable Vitiligo:A Preliminary Study
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost application Drug: Bimatoprost 0.03% topical ophthalmic solution

Primary Outcome Measures :
  1. repigmentation in the previously depigmented patch [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. safety profile of Topical Bimatoprost solution [ Time Frame: 4 month ]
    Hyperpigmentation of surrounding skin, Allergic reaction to bimatoprost, Hypertrichosis

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:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient of either sex and at least 10 years old
  2. Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
  3. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  4. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  1. Patients showing evidence of spontaneous repigmentation in any of the lesions
  2. Patients with rapidly progressive disease were also excluded.
  3. Patients with hypersensitivity to the drug or any of its constituents
  4. Patients with BSA > 5%

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 identifier (NCT number): NCT01202513

Sponsors and Collaborators
Gian Sagar Medical College and Hospital
Layout table for investigator information
Study Director: Rajeev Jain, M.D. PP
Principal Investigator: Tarun Narang, MD GSMCH
Layout table for additonal information
Responsible Party: Rajeev Jain, Gian Sagar Medical College and Hospital Identifier: NCT01202513    
Other Study ID Numbers: GSMCH230810
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: July 2010
Keywords provided by Gian Sagar Medical College and Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Pigmentation Disorders
Skin Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents