The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study
10 Years
80 Years
Both
Atopic Dermatitis, Psoriasis, Alopecia, Mycosis Fungoides, Urticaria, Dermatoses, Stretch Marks
Trial Information
The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses: An Open Pilot Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical assessment to determine the effectiveness of light treatment for skin condition
Outcome Time Frame:
Subjects will be evaluated at weeks 1, 2, and 4, then every month until the end of the study
Safety Issue:
No
Principal Investigator
John J Voorhees, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Michigan
Authority:
United States: Institutional Review Board
Study ID:
Derm 446
NCT ID:
NCT00129415
Start Date:
August 2000
Completion Date:
January 2011
Related Keywords:
- Atopic Dermatitis
- Psoriasis
- Alopecia
- Mycosis Fungoides
- Urticaria
- Dermatoses
- Stretch Marks
- UVA1
- UVB
- atopic dermatitis
- psoriasis
- alopecia
- mycosis fungoides (CTCL)
- urticaria
- inflammatory dermatoses
- stretch marks
- Alopecia
- Alopecia Areata
- Dermatitis
- Dermatitis, Atopic
- Mycoses
- Mycosis Fungoides
- Psoriasis
- Skin Diseases
- Urticaria
- Striae Distensae
Name | Location |
|---|---|
| University of Michigan Department of Dermatology | Ann Arbor, Michigan 48109 |
