Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.

Early Phase 1

Terminated

• Conditions: Dermatitis; Psoriasis
• Interventions: Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapy; Procedure: Topical Psoralen plus ultraviolet A (PUVA)

• Registration Number: NCT00217009
• Lead Sponsor: Mayo Clinic

Brief Summary

Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.

Exclusion Criteria

Age <18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Narrowband Ultraviolet B (TL-01UVB) Therapy	Narrowband Ultraviolet B (TL-01UVB) Therapy	treatments - 3x weekly for 15 months
Topical Psoralen plus ultraviolet A (PUVA)	Topical Psoralen plus ultraviolet A (PUVA)	Treatments - 3x weekly for 15 months

Primary Outcome Measures

Name	Time	Method
Number of treatments required to reach clearance	Baseline to 15 months

Secondary Outcome Measures

Name	Time	Method
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)	Baseline to 15 months
Change in global score	Baseline to 15 months
Number of patients reaching clearance	Baseline to 15 months
Adverse effects	Baseline to 15 months
Number of days in remission	Baseline to 15 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States