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

NCT ID: NCT01792245

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28

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.

Detailed Description

Hand dermatoses is a common problem which is characterized by itchy, erythematous and scaly lesions often with a long lasting and relapsing course. Patients presenting with these severe cutaneous changes are classified as having severe recalcitrant hand dermatoses. Treatment is difficult with considerable number of patients do not or only partially respond to the current treatments. Current treatment regimens mainly involve the use of high potency topical corticosteroids, which has only limited affect. Systemic treatment modalities have been utilized but have serious side effects with limited improvement of disease.

Several studies have shown the therapeutic effectiveness of the combination of topical psoralen with long wavelength ultraviolet A radiation (PUVA) in treating hand dermatoses. Topical PUVA is commonly associated with mild local sunburn reactions that often necessitate temporarily withholding treatment or decreasing the light dose. This subsequently leads to a delay in response or a prolongation of the treatment. Long term side effects include aging of the skin, hyperpigmentation, and a small increased risk of skin cancer that is more common in systemic PUVA. 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. Our hypothesis is that NB-UVB and topical PUVA will result in at least comparable improvement in hand psoriasis/eczema with less side effects associated with NB-UVB. We plan on conducting a prospective single-blind randomized clinical trial to compare the efficacy and safety of topical PUVA and NB-UVB in treating hand psoriasis/eczema.

Study Objectives

1. To compare the effect of topical PUVA and NB-UVB on visual cutaneous symptoms in patients presenting with recalcitrant hand dermatoses.

2. To compare the side effect profile of topical PUVA and NB-UVB when treating patients with recalcitrant hand dermatoses.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NB-UVB

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.

Group Type: ACTIVE_COMPARATOR

Phototherapy

Intervention Type: DEVICE

Topical PUVA

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.

Group Type: ACTIVE_COMPARATOR

Phototherapy

Intervention Type: DEVICE

Interventions

Phototherapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harvey Lui, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

The Skin Care Center, Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Harvey Lui, MD, FRCPC

Role: CONTACT

harvey.lui@ubc.ca

Facility Contacts

Harvey Lui, MD FRCPC

Role: primary

harvey.lui@ubc.ca

16048754111

Other Identifiers

H12-02854

Identifier Type: -

Identifier Source: org_study_id