Comparing the effectiveness and cost-effectiveness of narrowband ultraviolet B with optimal topical therapy (NB-UVB+OTT) versus OTT at 3 months in adult patients with atopic eczema (AE).
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: % patients with EASI50 (Eczema Area and Severity
Index) at 3 month follow-up.
Secondary outcome
Secondary outcome measures: Delta EASI, physician-reported clinical signs,
patient-reported symptoms, quality of life, long-term control,
cost-effectiveness and side effects at 1-3-6-9-12 months. Quantity and potency
topical steroid usage, time to starting systemic therapy and patient
satisfaction with received treatment. % patients reaching Treatment Target[1]
goals and % drop-outs with reasons at 3-6-9-12 months.
Background summary
Atopic eczema (AE) is a chronic fluctuating dermatological disease
characterized by a pruritic inflammation of the skin. The condition poses a
high global (financial) burden. One of the therapeutic options of AE is
phototherapy, with narrowband UVB (NB-UVB) being the most common. The evidence
of the (cost-)effectiveness of NB-UVB, however, is scarce and of low quality.
Study objective
Comparing the effectiveness and cost-effectiveness of narrowband ultraviolet B
with optimal topical therapy (NB-UVB+OTT) versus OTT at 3 months in adult
patients with atopic eczema (AE).
Study design
A pragmatic multicenter single blinded randomized controlled trial (RCT).
Intervention
A NB-UVB course (home or outpatient) for at least 8 and up to 16 weeks,
combined with OTT for at least 3 months, versus OTT alone
Study burden and risks
Visits will occur at baseline and 1-3-6-9-12 months after start. At baseline,
patient information is collected including an evaluation of medical history and
a physical examination to assess Fitzpatrick skin type and physician-reported
clinical signs. During each visit patients are asked to fill out
questionnaires. All patients will use daily OTT for at least 3 months. Patients
in the NB-UVB+OTT group undergo outpatient or at-home phototherapy 3 times a
week for 8 to 16 weeks. Risks are expected to be as in daily practice.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Adult (>=18 years of age) patient meeting the UK working party criteria for
atopic eczema;
- AE insufficiently controlled by standard topical care and therefore eligible
for NB-UVB or OTT;
- Investigator Global Assessment (IGA, 0-4) of >= 2 (moderate disease);
- Eczema Area and Severity Index (EASI) of >= 7 (moderate disease);
- Understood and voluntarily signed and dated an informed consent form prior to
any study-related procedure or has a legal representative who has, and is
willing to comply with the study*s requirements.
Exclusion criteria
- Contra-indication for NB-UVB;
o Genetic defects associated with photosensitivity or skin cancer;
o Heavily photo-damaged skin;
o History of multiple (>1) skin malignancies;
o Use of systemic immunosuppressants/immunomodulators;
o Use of medication associated with photosensitivity;
- Patient is already on systemic AE therapy;
- Patient is already on OTT in the past 2 months;
- NB-UVB or any systemic therapy in the past 9 months.
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 |
|---|---|
| CCMO | NL81882.018.22 |