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Topical Bimatoprost Solution 0.03%in Stable Vitiligo

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ClinicalTrials.gov Identifier: NCT01202513
Recruitment Status : Withdrawn (regulatory reasons)
First Posted : September 16, 2010
Last Update Posted : August 3, 2011
Sponsor:
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 Detailed Description

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 related topics: Vitiligo
Drug Information available for: Bimatoprost
U.S. FDA Resources

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01202513


Sponsors and Collaborators
Gian Sagar Medical College and Hospital
Investigators
Study Director: Rajeev Jain, M.D. PP
Principal Investigator: Tarun Narang, MD GSMCH

Publications:
Responsible Party: Rajeev Jain, Gian Sagar Medical College and Hospital
ClinicalTrials.gov Identifier: NCT01202513     History of Changes
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:
Vitiligo
Repigmentation

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents