Recruiting
Phase 2

Psoralen Ultraviolet A vs. Narrow Band Ultraviolet B

Sponsor:

University of British Columbia

Code:

NCT01792245

Conditions

Vitiligo

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Phototherapy

Study Details

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

Study ID

NCT01792245

Start date

Feb, 2013

Status verified date

Jun, 2015

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

Interventions

Phototherapy

Primary outcome measure

  • The primary endpoint will be based on the change in visual cutaneous symptoms as measured by the modified ASI score [ Time Frame: Baseline, every four weeks up to 16 weeks, and at 24 weeks ]

Central Contacts and Locations

Central contacts

Harvey Lui, MD, FRCPC

harvey.lui@ubc.ca

Locations

The Skin Care Center, Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E8

Contacts

Harvey Lui, MD FRCPC

16048754111harvey.lui@ubc.ca

Principal Investigator:

Sunil Kalia, MD FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Jul 2, 2015

Last verified

Jun, 2015

Keywords

  • narrow band UVB; PUVA; psoriasis; eczema; hand

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.