Topical Bimatoprost Solution 0.03%in Stable Vitiligo

This study has been withdrawn prior to enrollment.
(regulatory reasons)
Sponsor:
Information provided by:
Gian Sagar Medical College and Hospital
ClinicalTrials.gov Identifier:
NCT01202513
First received: September 14, 2010
Last updated: August 2, 2011
Last verified: July 2010
  Purpose

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 Intervention Phase
Vitiligo
Repigmentation
Drug: Bimatoprost 0.03% topical ophthalmic solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Topical Bimatoprost Solution 0.03% in Stable Vitiligo:A Preliminary Study

Resource links provided by NLM:


Further study details as provided by Gian Sagar Medical College and Hospital:

Primary Outcome Measures:
  • repigmentation in the previously depigmented patch [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety profile of Topical Bimatoprost solution [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
    Hyperpigmentation of surrounding skin, Allergic reaction to bimatoprost, Hypertrichosis


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bimatoprost application Drug: Bimatoprost 0.03% topical ophthalmic solution

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
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%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202513

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

Publications:
Responsible Party: Rajeev Jain, Gian Sagar Medical College and Hospital
ClinicalTrials.gov Identifier: NCT01202513     History of Changes
Other Study ID Numbers: GSMCH230810
Study First Received: September 14, 2010
Last Updated: August 2, 2011
Health Authority: India: Institutional Review Board

Keywords provided by Gian Sagar Medical College and Hospital:
Vitiligo
Repigmentation

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 28, 2014