Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129415
Status:
TERMINATED
Last Update Posted:
2015-05-22
First Post:
2005-08-09
Brief Title:
Ultraviolet UVA and UVB Light Therapy in the Treatment of Inflammatory Skin Conditions
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effectiveness of UVA1 and UVB Irradiation in the Treatment of Inflammatory Dermatoses An Open Pilot Study
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Jcm2 The maximum UVB dose will be 4000 mJcm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None