The objective of this study is to evaluate the difference in clinical effects (onset and degree of repigmentation) of NB-UVB and fluticasone proprionate vs NB-UVB alone.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The onset and degree of pigment spread is assessed by digital image analysis,
and the patients and doctors satisfaction will be evaluated
Secondary outcome
-
Background summary
Vitiligo is a common idiopathic acquired pigment disorder, which is
characterised by spreading depigmented macules, often with a progressive
course. Several treatment options are available; non-surgical therapies and
surgical therapies. Non-surgical therapies include topical treatment
(fluticasone proprionate or tacrolimus) and phototherapy (narrow band Ultra
Violet B (NB-UVB)). Fluticasone proprionate is applied once a day the first 3
months, month 3-12, 3 times a week (pulse scheme) on affected areas and
suppresses the depigmenting process. Exposure to NB-UVB twice a week stimulates
the spreading of melanocytes.
To our knowledge to date there are no publications comparing NB-UVB and topical
treatment of fluticasone proprionate to NB-UVB alone.
Study objective
The objective of this study is to evaluate the difference in clinical effects
(onset and degree of repigmentation) of NB-UVB and fluticasone proprionate vs
NB-UVB alone.
Study design
Prospective single blinded randomised controlled study
Intervention
NB UVB phototherapy twice a week for twelve months with either topical use of
fluticasone proprionate or NB UVB phototherapy alone
Study burden and risks
Subjects participating in the study will be asked to visit the SNIP 6 times.
The time investment will be 15 minutes per visit. No invasive procedures will
be performed. Known side effects of the NB-UVB phototherapy are redness,
pruritus, xerosis cutis, burning sensation and conjunctivitis. All together the
burden due to the study is low and the risk for local side effects is low.
Systemic side effects (suppression of the adrenocortex) are associated with the
involved treatment (fluticasone proprionate 0.05% cream 0.05%), however because
a maximum of 30% body area is treated (i), and the regions which are known to
have a higher absorption are excluded (periorbital, axillary, inguinal and
genital area) (ii), this side effect is not expected.
Meibergdreef 35
1105AZ, Amsterdam
NL
Meibergdreef 35
1105AZ, Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with active vitiligo, eligible for NB-UVB phototherapy;
Subjects attending the outpatient department of the SNIP;
Adult patients: * 18 years;
Subject is willing and able to give written informed consent.
Exclusion criteria
With a personal or a family history of skin cancer (non-melanoma skin cancer: first degree family members, melanoma: any family member)
With a personal history of photosensitivity and/or phototoxicity disorders
With skin type I (according to Fitzpatrick classification I-VI)
Who are pregnant
Who are taking medications known to cause photosensitivity and/or phototoxicity and chronic or very frequent use of any medication that can influence the UVB response (eg. tetracycline, retinoids, sulfonamids, psoralens, NSAID*s)
With other skin diseases that would impair evaluation of repigmentation, such as psoriasis and eczema.
Who are 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-006903-22-NL |
| Other | NA |
| CCMO | NL25499.018.08 |