The objective of this study is to evaluate the clinical effects (start and grade of repigmentation) of NB-UVB versus 308-nm Excimer lasertherapy on pigment spread after minigrafting in vitiligo patients.
ID
Source
Brief title
Condition
- Pigmentation disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage, start and grade of repigmentation
Secondary outcome
Patient satisfaction
Background summary
Vitiligo is a common, idiopathic acquired pigment disorder. Several treatment
options are available; non-surgical therapies and surgical therapies. Surgical
therapies can be considered for stable vitiligo patches. In the Netherlands
Institute for Pigment Disorders (NIPD) we routinely use the autologous
minigrafting technique. This technique is relatively simple among the surgical
modalities and has been an effective therapy for stable localised and
generalised vitiligo. Exposure to Narrow-Band Ultraviolet B (NB-UVB)following
the minigrafting stimulates the spreading of melanocytes from the treated
vitiligo lesion and obtains a faster rate of repigmentation. Recently the
308-nm Excimerlaser is introduced as an effective method of treatment for
vitiligo and appears to be more effective than NBUVB as it produces more rapid
and profound repigmentation.
To our knowledge, no studies have been published on minigrafting followed by
NB-UVB versus Excimer laser.
Study objective
The objective of this study is to evaluate the clinical effects (start and
grade of repigmentation) of NB-UVB versus 308-nm Excimer lasertherapy on
pigment spread after minigrafting in vitiligo patients.
Study design
Prospective single blinded randomised within-patient controlled study at the
Netherlands Institute of Pigmentary Disorders (NIPD), Department of
Dermatology, Academic Medical Centre, University of Amsterdam, the Netherlands.
The study consists of the following steps:
a. The Pre-treatment: screening visit before starting treatment (T0)
b. Treatment: Start treatment (T1): Minigrafting and NB-UVB on one lesion and
308-nm Excimer laser on the other lesion
c. End of treatment (T7).
d. Clinical investigations at week 3, week 6, week 9, week 12, month 6 and
month 12 (T2, T3, T4, T5, T6 and T7 respectively).
e. Digital Image analysis (DIA) and Reflectance Spectroscopy at T1, T5, T6 and
T7
f. Efficacy parameters (appearance of repigmentation time, grade of
repigmentation) will be assessed at T1-T7
g. Patient*s satisfaction/preference (T5, T6 and T7)
Intervention
Minigrafting in two symmetrical vitiligo patches on the trunk or extremties
Study burden and risks
The patient needs to come to the doctor for clinical investigations 6 times
after the minigrafting procedure. This will not be extra burden for the patient
as the treatment with the excimer laser/ NB-UVB is already in the institute for
pigmentdisorders, and the clinical investigations will be directly after the
laser/NB-UVB treatment ( the patient does NOT have to come an extra time to the
institute).
The minigrafting procedure is a standard treatment in the institue for pigment
disorders.
Meibergdreef 35
1105 AZ
Nederland
Meibergdreef 35
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
i. Consecutive patients, diagnosed with stable vitiligo vulgaris* with symmetrical vitiligo patches
*Vitiligo vulgaris: a few to many widespread depigmented macules over the entire body, with often a symmetrically distribution pattern.
Stable means: no expansion of existing lesions or appearance of new lesions during the previous 6 months, absence of Koebner*s phenomenon and a positive minigrafting test
ii. Patients, eligible for minigrafting and NB-UVB/excimer therapy
iii. Adult patients: * 18 years
iv. Patients who have given written informed consent
Exclusion criteria
Patients:
i. With a history of hypertrophic scarring and/or keloid
ii History of allergic/phototoxic reaction (Lidocaine, Tegaderm, Suture strips, sunlight)
iii With a negative minigrafting test
iv With a personal or a family history of skin cancer (non-melanoma skin cancer: first degree family members, melanoma: any family member)
v. With a personal history of photosensitivity and/or phototoxicity disorders
vi. With skin type I (according to Fitzpatrick classification I-VI)
vii. Who are pregnant
viii. 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)
ix. With other skin diseases that would impair evaluation of repigmentation, such as psoriasis and eczema.
x. Who are not able to have 2 times weekly NB-UVB/Excimer therapy.
xi. With local immunosuppressive treatment or 6 weeks prior to enrolment. For these patients a washout period of 6 weekswill be required.
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 | NL12606.018.06 |