Topical Psoralen Ultraviolet Light A Versus Narrow Band Ultraviolet Light B Treatment for Recalcitrant Dermatoses of the Hand

NCT01792245 | Unknown Phase 2

• 1 other identifier: H12-02854
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hand psoriasis/eczema is a common problem which is characterized by itchy, erythematous and scaly lesions often with a long lasting and relapsing course. Treatment is difficult with considerable number of patients do not or only partially respond to the current treatments. Several studies have shown the therapeutic effectiveness of the combination of topical psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand psoriasis/eczema. Topical PUVA is has several short- and long-term side effects. Narrow band ultraviolet B (NB-UVB) has emerged recently as an important treatment for a variety of photoresponsive diseases including psoriasis and eczema. For most conditions (other than hand psoriasis/eczema) NB-UVB has been shown to have similar therapeutic results to PUVA with less side effects. There are only a few studies published on the efficacy of NB-UVB for hand psoriasis/eczema. Therefore, this study is aimed at comparing the efficacy and safety of t-PUVA and NB-UVB in treating these conditions.

Conditions

Vitiligo

Keywords

narrow band UVB; PUVA; psoriasis; eczema; hand

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be based on the change in visual cutaneous symptoms as measured by the modified ASI score

  Baseline, every four weeks up to 16 weeks, and at 24 weeks

Secondary Outcomes (2)

• The overall change in physical appearance of the hand will be assessed by the global assessment

  Every four weeks up to 16 weeks, and at 24 weeks

• Adverse effects will be assessed every four weeks, including erythema, pruritus, and tanning. This will be assessed using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.

  Every four weeks up to 16 weeks

Study Arms (2)

NB-UVB

ACTIVE COMPARATOR

This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA. For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB. Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly. Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.

Device: Phototherapy

Topical PUVA

ACTIVE COMPARATOR

This single-blinded randomized bilateral left to right controlled comparison clinical trial of 24 weeks duration will compare the efficacy of NB-UVB to t-PUVA. For each patient one hand will be randomly assigned to receive t-PUVA and the other hand will receive NB-UVB. Each hand will receive treatment with either NB-UVB or topical PUVA three times weekly. Treatment will be performed until complete or almost complete clearing of psoriasis/eczema or until 50 exposures (over 16 weeks) have been reached, whichever comes first.

Device: Phototherapy

Interventions

Phototherapy DEVICE

NB-UVB; Topical PUVA

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic symmetrical severe hand psoriasis and eczema (allowing up to 15% difference in surface area between both hands). These include patients that have received topical corticosteroids previously and may or may have not responded to treatment.
• Subjects should be 18 years old or older.

You may not qualify if:

• Any serious medical illness that will restrict the patient's ability to receive light treatments. That includes skin conditions, such as skin cancer or severe blistering conditions, or any serious medical conditions affecting the sensation of the extremities (eg. diabetic neuropathy, cervical stenosis).
• Patients known to have a photosensitivity disorder
• Patients with a history of intolerance to UVB and/or UVA light therapy.
• Any subject who is on treatment or was on treatment for hand psoriasis/eczema less than two (topical) or four (systemic/phototherapy) weeks prior to enrollment in the study.
• Pregnancy or breast-feeding.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The Skin Care Center, Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E8, Canada

RECRUITING

MeSH Terms

Conditions

Vitiligo; Psoriasis; Eczema

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Harvey Lui, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey Lui, MD, FRCPC

CONTACT

harvey.lui@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

CA (1)