Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01254240
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2010-12-02
Brief Title:
Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Randomized Double-blind Phase 2 Study of Impact of Ultraviolet A UVA on Pruritus During Ultraviolet AB UVAB Phototherapy of Inflammatory Dermatoses
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRUVAB
Brief Summary:
This is a double-blind prospective randomized monocenter study comparing the efficacy of two phototherapy ultraviolet spectra on pruritus itching of inflammatory skin diseases 40 patients per treatment in total 80 study participants
Detailed Description:
In patients with a skin disease and the given indication for a phototherapy with Ultraviolet B narrow-band UVB narrowband 311nm with or without Ultraviolet A UVA 320-400 nm the subjective pruritus levels and clinical severity will be measured before during and after completion of the 16-week therapy 40 patients per group Patients will be recruited in the department of dermatology of the University Hospital Zürich in the outpatient clinic Following oral and written consent pruritus levels will be measured by a visual analogue scale and a new detailed pruritus score 2 before start of therapy every 4 weeks after start as well as after completion of the phototherapy Phototherapy is to be administered 3 times per week The study includes 5 study visits and up to 43 treatment visits that include administration of phototherapy only
A physical examination including clinical scores Psoriasis Area and Severity Index PASI Eczema Area and Severity Index EASI Physicians static global assessment PSGA and Dermatology Dynamics Vector DDV will be performed at every visit During the first physical examination the Fitzpatrick-skin type of patient will be recorded the demographics the Body Mass Index BMI diagnosis past medical history co-morbidities concomitant medication and the number of past UVAB treatments
A physical examination including clinical scores Psoriasis Area and Severity Index PASI Eczema Area and Severity Index EASI Physicians static global assessment PSGA and Dermatology Dynamics Vector DDV will be performed at every visit During the first physical examination the Fitzpatrick-skin type of patient will be recorded the demographics the Body Mass Index BMI diagnosis past medical history co-morbidities concomitant medication and the number of past UVAB treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None