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

Psoriasis Clinical Trial

Official title:

A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00217009
• Other study ID #: 2435-04
• Status: Terminated
• Phase: Phase 0
• First received: September 14, 2005
• Last updated: May 18, 2015
• Start date: March 2005
• Est. completion date: November 2008

Study information

• Verified date: May 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Psoriasis

Intervention

Procedure:
• Narrowband Ultraviolet B (TL-01UVB) Therapy

• Topical Psoralen plus ultraviolet A (PUVA)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatments required to reach clearance		Baseline to 15 months	No
Secondary	Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)		Baseline to 15 months	No
Secondary	Change in global score		Baseline to 15 months	No
Secondary	Number of patients reaching clearance		Baseline to 15 months	No
Secondary	Adverse effects		Baseline to 15 months	Yes
Secondary	Number of days in remission		Baseline to 15 months	Yes