Topical Bimatoprost Solution 0.03%in Stable Vitiligo

NCT01202513 | Withdrawn Phase 4 DMC

• 1 other identifier: GSMCH230810
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitiligo; Repigmentation

Keywords

Vitiligo; Repigmentation

Outcome Measures

Primary Outcomes (1)

• repigmentation in the previously depigmented patch

  4 months

Secondary Outcomes (1)

• safety profile of Topical Bimatoprost solution

  4 month

Study Arms (1)

Bimatoprost application

EXPERIMENTAL

Drug: Bimatoprost 0.03% topical ophthalmic solution

Interventions

Bimatoprost 0.03% topical ophthalmic solution DRUG

Bimatoprost application

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Gian Sagar Medical College and Hospital: lead

Related Publications (6)

• 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. doi: 10.1002/jcp.1041420216.

  PMID: 2303529 BACKGROUND

• 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. doi: 10.1111/1523-1747.ep12285717.

  PMID: 3528310 BACKGROUND

• 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.

  PMID: 11296032 BACKGROUND

• 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. doi: 10.1034/j.1600-0749.2000.130305.x.

  PMID: 10885672 BACKGROUND

• Hossain D. Assessment scale used in vitiligo. J Am Acad Dermatol. 2005 Jun;52(6):1110-1. doi: 10.1016/j.jaad.2004.02.028. No abstract available.

  PMID: 15928648 BACKGROUND

• 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. doi: 10.1111/1523-1747.ep12471536.

  PMID: 3305717 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Bimatoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Rajeev Jain, M.D.

  PP

  STUDY DIRECTOR

• Tarun Narang, MD

  GSMCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 3, 2011

Record last verified: 2010-07