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This study has been withdrawn prior to enrollment.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

History of Changes

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:

Genetics Home Reference related topics: vitiligo

MedlinePlus related topics: Vitiligo

Drug Information available for: Bimatoprost

U.S. FDA Resources

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:

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

Exclusion Criteria:

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

Contacts and Locations

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:

Friedmann PS, Wren FE, Matthews JN. Ultraviolet stimulated melanogenesis by human melanocytes is augmented by di-acyl glycerol but not TPA. J Cell Physiol. 1990 Feb;142(2):334-41.

Nordlund JJ, Collins CE, Rheins LA. Prostaglandin E2 and D2 but not MSH stimulate the proliferation of pigment cells in the pinnal epidermis of the DBA/2 mouse. J Invest Dermatol. 1986 Apr;86(4):433-7.

Wand M, Ritch R, Isbey EK Jr, Zimmerman TJ. Latanoprost and periocular skin color changes. Arch Ophthalmol. 2001 Apr;119(4):614-5. No abstract available.

Prota G, Vincensi MR, Napolitano A, Selen G, Stjernschantz J. Latanoprost stimulates eumelanogenesis in iridial melanocytes of cynomolgus monkeys. Pigment Cell Res. 2000 Jun;13(3):147-50.

Hossain D. Assessment scale used in vitiligo. J Am Acad Dermatol. 2005 Jun;52(6):1110-1. No abstract available.

Tomita Y, Iwamoto M, Masuda T, Tagami H. Stimulatory effect of prostaglandin E2 on the configuration of normal human melanocytes in vitro. J Invest Dermatol. 1987 Sep;89(3):299-301.

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
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013

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