Patients With Active Non-segmental Vitiligo.Phase 4NCT01246921
Effect of Fluticasone Proprionate 0.05% on Narrow Band UV-B in Active Vitiligo
A Phase 4 study testing Fluticasone proprionate 0.05% cream in people with Patients With Active Non-segmental Vitiligo. and Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised by the development of depigmented macules. It develops probably due to immunedestruction of melanocytes. Most effective therapies are immunsuppresive: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients With Active Non-segmental Vitiligo., Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%, Cream Compared to NB-UVB Alone in Patients With Non-segmental Vitiligo
- What is being tested?
- Fluticasone proprionate 0.05% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Institute for Pigments Disorders
Amsterdam, 1105AZ
Albert Wolkerstorfer, M.D. PhD
About this study
Official title: Effect of Fluticasone Proprionate 0.05% Cream on Narrow Band UV-B Phototherapy in Active Vitiligo: a Randomised Single Blinded Controlled Trial
Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised by the development of depigmented macules. It develops probably due to immunedestruction of melanocytes. Most effective therapies are immunsuppresive:
- local immunesuppressives like corticosteroids and calcineurin inhibitors
- phototherapy like PUVA and NB-UVB phototherapy. NB-UVB is the first choice A synergistic effect of UVA and topical corticosteroids (fluticasone proprionate 0.05% cream) has been described by Westerhof et al. in 1999. To our knowledge to date there are no publications comparing NB-UVB combined with a topical corticosteroid and NB-UVB alone.
Read more
Objective: The objective of this study is to evaluate the clinical effects (onset and degree of repigmentation) of fluticasone proprionate 0.05% cream (thrice weekly) on NB-UVB phototherapy twice weekly for a period of 12 months.
Study design: Prospective single blinded randomised controlled study. Study population: Consecutive patients ≥ 18 years, diagnosed with active vitiligo vulgaris who will receive NB-UVB phototherapeutic treatment at the Netherlands Institute for Pigment Disorders at the Academic Medical Centre (AMC), University of Amsterdam.
Methods: The patient will be randomised for either NB-UVB phototherapy and fluticasone proprionate 0.05% cream or NB-UVB phototherapy alone for 12 consecutive months.
Main study parameters/endpoints: The onset and degree of repigmentation is assessed by digital image analysis of a target lesion and blinded global physician assessment. Furthermore, the patients and doctors satisfaction will be assessed and changes of immunohistochemical parameters will be analysed in skin biopsies.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study will be asked to visit the institute 4 times. The time investment will be 20 minutes per visit. Additionally, patients will be asked for consent to take punch biopsies (3 mm) at the beginning and at the end of the treatment period. Hence, skin biopsies are not compulsory for participation in this study. Patients may chose to participate in the clinical non invasive part of the study. Known side effects of the NB-UVB phototherapy are redness, pruritus, xerosis cutis, burning sensation and conjunctivitis. These side-effects however, are largely dose-dependent and avoidable. Corticosteroid associated systemic side-effects (suppression of the adrenocortex) will be minimized by treating only a limited body surface [a maximum of 30% body surface] and by using an intermittent application scheme of three days a week in the long term treatment. The regions which are known to have a higher absorption are excluded (periorbital, axillary, inguinal and genital area). Both topical corticosteroids and NB-UVB are part of the Dutch and British guidelines for the treatment of vitiligo. There is no presumptive evidence or indication that the combination of these therapies may result in a higher risk of side effects.
All together the burden due to the study is low and the risk for systemic or local side effects is low.
- Conditions
- Patients With Active Non-segmental Vitiligo., Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%, Cream Compared to NB-UVB Alone in Patients With Non-segmental Vitiligo
- Being tested
- Fluticasone proprionate 0.05% cream
- Keywords
- Vitiligo, repigmentation, satisfaction
- Medical subject headings
- Vitiligo, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone proprionate 0.05% creamDrug
Also called Cutivate cream
Fluticasone proprionate 0.05% cream . In each patient a representative target lesion will be selected which will be assessed by digital analysis. Patients will apply Fluticasone proprionate 0.05% cream once daily during the first 3 months. I nthe following 9 months FP will be applied in a scheme of 3 days per week
| Study group | Role | What they receive |
|---|---|---|
| fluticasone proprionate 0.05 % | Active comparator | Group reveiving 12 months NB-UVB phototherapy twice a week in combination with fluticasone proprionate 0.05 % cream in an intermittent scheme Receives: Drug: Fluticasone proprionate 0.05% cream |
| no intervention | No intervention | Group receiving 12 months NB-UVB phototherapy twice weekly, without any topical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation of the vitiligo lesions
Degree of repigmentation is assessed by digital analysis of a target lesion by a blinded global physician assessment
Measured: 15 months
Secondary outcomes (1)
Patients satisfaction
satisfaction/preference
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Active Non-segmental Vitiligo.Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246921
- Sponsor's protocol ID
- SNIP_UVB
- Status last verified
- Jun 2009
- First submitted
- 23 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fluticasone Proprionate 0.05% Cream on Narrow Band UV-B Phototherapy in Active Vitiligo: a Randomised Single Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT01246921
- Acronym / sponsor ID
- SNIP_UVB
- Conditions
- Patients With Active Non-segmental Vitiligo., Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%, Cream Compared to NB-UVB Alone in Patients With Non-segmental Vitiligo
- Keywords
- Vitiligo, repigmentation, satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: Vitiligo vulgaris is a common acquired pigment disorder, which is characterised by the development of depigmented macules. It develops probably due to immunedestruction of melanocytes. Most effective therapies are immunsuppresive:
- local immunesuppressives like corticosteroids and calcineurin inhibitors
- phototherapy like PUVA and NB-UVB phototherapy. NB-UVB is the first choice A synergistic effect of UVA and topical corticosteroids (fluticasone proprionate 0.05% cream) has been described by Westerhof et al. in 1999. To our knowledge to date there are no publications comparing NB-UVB combined with a topical corticosteroid and NB-UVB alone.
Objective: The objective of this study is to evaluate the clinical effects (onset and degree of repigmentation) of fluticasone proprionate 0.05% cream (thrice weekly) on NB-UVB phototherapy twice weekly for a period of 12 months.
Study design: Prospective single blinded randomised controlled study. Study population: Consecutive patients ≥ 18 years, diagnosed with active vitiligo vulgaris who will receive NB-UVB phototherapeutic treatment at the Netherlands Institute for Pigment Disorders at the Academic Medical Centre (AMC), University of Amsterdam.
Methods: The patient will be randomised for either NB-UVB phototherapy and fluticasone proprionate 0.05% cream or NB-UVB phototherapy alone for 12 consecutive months.
Main study parameters/endpoints: The onset and degree of repigmentation is assessed by digital image analysis of a target lesion and blinded global physician assessment. Furthermore, the patients and doctors satisfaction will be assessed and changes of immunohistochemical parameters will be analysed in skin biopsies.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects participating in the study will be asked to visit the institute 4 times. The time investment will be 20 minutes per visit. Additionally, patients will be asked for consent to take punch biopsies (3 mm) at the beginning and at the end of the treatment period. Hence, skin biopsies are not compulsory for participation in this study. Patients may chose to participate in the clinical non invasive part of the study. Known side effects of the NB-UVB phototherapy are redness, pruritus, xerosis cutis, burning sensation and conjunctivitis. These side-effects however, are largely dose-dependent and avoidable. Corticosteroid associated systemic side-effects (suppression of the adrenocortex) will be minimized by treating only a limited body surface [a maximum of 30% body surface] and by using an intermittent application scheme of three days a week in the long term treatment. The regions which are known to have a higher absorption are excluded (periorbital, axillary, inguinal and genital area). Both topical corticosteroids and NB-UVB are part of the Dutch and British guidelines for the treatment of vitiligo. There is no presumptive evidence or indication that the combination of these therapies may result in a higher risk of side effects.
All together the burden due to the study is low and the risk for systemic or local side effects is low.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone proprionate 0.05 % | Active comparator | Drug: Fluticasone proprionate 0.05% creamGroup reveiving 12 months NB-UVB phototherapy twice a week in combination with fluticasone proprionate 0.05 % cream in an intermittent scheme |
| no intervention | No intervention | –Group receiving 12 months NB-UVB phototherapy twice weekly, without any topical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- non-segmental vitiligo
- Eligible for NB-UVB therapy
- Subjects attending the outpatient department of the SNIP
- patients > 18 years
- Skin type II-V
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone proprionate 0.05% creamAlso: Cutivate creamFluticasone proprionate 0.05% cream . In each patient a representative target lesion will be selected which will be assessed by digital analysis. Patients will apply Fluticasone proprionate 0.05% cream once daily during the first 3 months. I nthe following 9 months FP will be applied in a scheme of 3 days per week | Drug | fluticasone proprionate 0.05 % |
Primary outcome
Repigmentation of the vitiligo lesions
Time frame: 15 months
Degree of repigmentation is assessed by digital analysis of a target lesion by a blinded global physician assessment
1 secondary outcome
Patients satisfaction
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
Related trials for Patients With Active Non-segmental Vitiligo.
RecruitingObservational study
Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study
Non-Segmental Vitiligo (NSV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone proprionate 0.05% cream in people with Patients With Active Non-segmental Vitiligo. and Evaluation of the Efficacy of UVB and Fluticason Proprionate 0.05%, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marije Kroon, M.D. (+31205666955, mwkroon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation of the vitiligo lesions (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.