Ultraviolet (UVA and UVB) Light Therapy in the Treatment of Inflammatory Skin Conditions

NCT ID: NCT00129415

Last Updated: 2015-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2011-01-31

Brief Summary

The purpose of this investigation is to study the effectiveness of longer wavelength UVA1 (340-400nm) or shorter wavelength ultraviolet B [UVB] (290-320nm) irradiation in the treatment of inflammatory skin conditions (such as: atopic dermatitis, psoriasis, mycosis fungoides, alopecia areata, stretch marks and urticaria).

This research study aims to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1. This device has not been approved by the Food and Drug Administration (FDA) for general use in this country, as of yet, but it has been used quite successfully in Europe for several years in treating such conditions as scleroderma, atopic dermatitis, urticaria pigmentosa and other skin conditions.

Instead of UVA1 therapy, patients may receive ultraviolet radiation of a specific wavelength known as UVB. UVA1 light is a longer wavelength and therefore a lower energy wavelength than UVB. UVB light is often the light associated with getting a sunburn since it has a higher level of energy. UVB light has been used successfully in the treatment of many skin conditions.

Detailed Description

The purpose of this investigation is to study the effectiveness of longer wavelength UVA1 (340-400nm) or shorter wavelength UVB (290-320nm) irradiation in the treatment of inflammatory skin conditions. Inflammatory dermatoses refer to conditions like atopic dermatitis (eczema) and psoriasis in which circulating leukocytes (T cells, neutrophils, and monocytes) infiltrate the skin. The infiltrating cells may be of malignant phenotype as in mycosis fungoides (cutaneous T cell lymphoma-CTCL). Up to 50 patients with one of these diagnoses or related conditions will participate in this study. The affected areas on the body will be treated with UVA1 or UVB for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2. The maximum UVB dose will be 4000 mJ/cm2. This UVA1 dosing schedule has been safely used in Germany for treating patients with atopic dermatitis, mycosis fungoides, granuloma annulare, scleroderma, and urticaria pigmentosa. Subjects will be evaluated clinically at baseline, weeks 1, 2, 4, and then at monthly intervals. More frequent evaluation may be required depending on the condition being studied. Paired skin biopsies may be taken from involved and uninvolved (or treated and untreated) areas before and during UV therapy.

Conditions

Atopic Dermatitis; Psoriasis; Alopecia; Mycosis Fungoides; Urticaria; Dermatoses; Stretch Marks

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVA1 Irradiation

UVA 1 Irradiation (Sellemed UVA1 light source) up to 130 J/cm2

Group Type: EXPERIMENTAL

UVA1 Irradiation

Intervention Type: PROCEDURE

The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source) for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2.

UVB Irridiation

UVB Irradiation maximum dose of 4000 mJ/cm2

Group Type: EXPERIMENTAL

UVB Irradiation

Intervention Type: PROCEDURE

The affected areas on the body will be treated with UVB light for up to 5 times per week for 16 weeks. The maximum UVB dose will be 4000 mJ/cm2.

Interventions

UVA1 Irradiation

The affected areas on the body will be treated with UVA1 (Sellemed UVA1 light source) for up to 5 times per week for 16 weeks. The UVA1 dose will be up to 130 J/cm2.

Intervention Type: PROCEDURE

UVB Irradiation

The affected areas on the body will be treated with UVB light for up to 5 times per week for 16 weeks. The maximum UVB dose will be 4000 mJ/cm2.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Ages: 10-80 years
• Clinical diagnosis of inflammatory dermatoses such as atopic dermatitis, psoriasis, mycosis fungoides, alopecia areata, and urticaria.
• No disease states or physical conditions that would impair evaluation of the test site.
• Willing and able to receive UVA1 or UVB, as directed in the protocol; make evaluation visits; and follow protocol restrictions.
• Signed, written, witnessed, informed consent form.
• Must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria

• History of photosensitivity (development of hives or bumps with exposure to light).
• UVA1 or UVB irradiation hypersensitivity in a UVA1/UVB photo-provocation test.
• Pregnant or nursing women.
• Involved in an investigational study within the previous 4 weeks.
• Presence of bacterial superinfection.
• Taken oral therapy for skin condition within the last 4 weeks
• Topical steroid therapy within the last 2 weeks
• History of excessive scar formation or keloids

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Yolanda Rosi Helfrich

Assistant Professor of Dermatology, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John J Voorhees, MD

Role: STUDY_CHAIR

University of Michigan

Locations

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Countries

United States

References

Wang F, Garza LA, Cho S, Kafi R, Hammerberg C, Quan T, Hamilton T, Mayes M, Ratanatharathorn V, Voorhees JJ, Fisher GJ, Kang S. Effect of increased pigmentation on the antifibrotic response of human skin to UV-A1 phototherapy. Arch Dermatol. 2008 Jul;144(7):851-8. doi: 10.1001/archderm.144.7.851.

Reference Type: DERIVED

PMID: 18645136 (View on PubMed)

Other Identifiers

Derm 446

Identifier Type: -

Identifier Source: org_study_id