Effect of Fluticasone Proprionate 0.05% on Narrow Band UV-B in Active Vitiligo

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01246921
• Date of registration: 23/11/2010
• Prospective Registration: No
• Primary sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Public title: Effect of Fluticasone Proprionate 0.05% on Narrow Band UV-B in Active Vitiligo
• Scientific title: Effect of Fluticasone Proprionate 0.05% Cream on Narrow Band UV-B Phototherapy in Active Vitiligo: a Randomised Single Blinded Controlled Trial
• Date of first enrolment: September 2009
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01246921
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Netherlands

Contacts

• Name: Marije Kroon, M.D.

Key inclusion & exclusion criteria

Inclusion Criteria:

- non-segmental vitiligo

- Eligible for NB-UVB therapy

- Subjects attending the outpatient department of the SNIP

- patients > 18 years

- Skin type II-V

- patients with active vitiligo: progression of older lesions or development of new
lesion during the last 6 months

- Subject is willing and able to give written informed consent

Exclusion Criteria:

- Personal or a family history of skin cancer ( non-melanoma skincancer: first degree
family members, melanoma: any family members)

- Personal history of photosensitivity and/or phototoxicity disorders

- pregnancy

- Taking medication known to cause photosensitivity, phototoxicity, immune suppression
and chronic or very frequent use of any medication that can influence the UVB
response (e.g. tetracycline, retinoids, sulfonamids, psoralens)

- Other skin diseases that would impair the evaluation of repigmentation

- not able to have 2 times weekly NB-UVB phototherapy

- With local immunosuppressive treatment or 6 weeks prior to enrolment. For these
patients a washout period of 6 weeks will be required.

- Contact-allergy for any of the parts in fluticasone proprionate



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%

Cream Compared to NB-UVB Alone in Patients With Non-segmental Vitiligo

Patients With Active Non-segmental Vitiligo.

Intervention(s)

Drug: Fluticasone proprionate 0.05% cream

Primary Outcome(s)

Repigmentation of the vitiligo lesions [Time Frame: 15 months]

Secondary Outcome(s)

Patients satisfaction [Time Frame: 15 months]

Secondary ID(s)

SNIP_UVB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors