The primary objective of this study is to compare the effectiveness of two different phototherapy protocols (continuous treatment for 6 months, or 2 continuous treatments for 2 months separated by one month interruption (2-1-2-1), with a total…
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Colour measurement by visual assessment and reflectance spectroscopy, patient*s
satisfaction and visual assessment of side effects.
Secondary outcome
not applicable
Background summary
Narrow band ultraviolet B (nb UVB) phototherapy is the first choice for the
treatment of active vitiligo (newly developed depigmented macules in the last 3
months). Phototherapy requires quite long periods (6 months * 1 year) before
repigmentation of vitiligo takes place. Side effect of phototherapeutic
treatment is represented by the cumulative long term effects of ultraviolet
rays: premature ageing of the skin (wrinkles, spots etc.) and the appearance of
skin cancer/neoplasia. Our aim is to get the best results from phototherapy
whilst limiting its length.
Study objective
The primary objective of this study is to compare the effectiveness of two
different phototherapy protocols (continuous treatment for 6 months, or 2
continuous treatments for 2 months separated by one month interruption
(2-1-2-1), with a total length of 6 months as well). Our aim is to verify
whether interrupting a cycle of phototherapy is useful or not. This
interruption might make the ultraviolet rays* stimulus on cells producing
melanin more effective, and may also reduce the long term damage caused by
ultraviolet rays.
Study design
Prospective single blinded randomised controlled multi centre study.
Intervention
nb UVB phototherapy
Study burden and risks
Subjects participating in the study will be asked to visit the SNIP 5 times.
The time investment will be 15 minutes per visit. No invasive procedures will
be performed. The objective colour measurement involves a handheld device
producing a harmless flash of light. 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 moderately low and the risk for
local side effects is low. Systemic side effects are not associated with the
involved treatment.
Meibergdreef 35
1105AZ, Amsterdam
Nederland
Meibergdreef 35
1105AZ, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Active vitiligo (newly developed depigmented macules in the last 3 months)
Subjects attending the outpatient department of the SNIP;
Aged between 18-60 years;
Subject is willing and able to give written informed consent.
Exclusion criteria
Subjects not competent to understand what is involved.
Skin photo type I
Previous treatment with any kind of phototherapy in the last 6 months
Acral vitiligo (only hands and feet are affected)
Lesion(s) suspicious for malignancy
Pregnancy
High exposure to sunlight (vacation in southern countries) or UV light (UVA or UVB)
Design
Recruitment
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 |
|---|---|
| CCMO | NL21475.018.08 |