Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476697
Status:
TERMINATED
Last Update Posted:
2015-07-27
First Post:
2007-05-18
Brief Title:
UVA1 Light for Scleroderma and Similar Conditions
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effectiveness of UVA1 Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix An Open Pilot Study
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inactivity
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 evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin eg keloid a thick scar from growth of fibrous tissue scleroderma deposits of fibrous tissue in the skin and acne keloidalis nuchae keloids on the back of the neck or hairline old burn scars granuloma annulare or other similar skin conditions This UVA1 dosing schedule has been used successfully in Germany for various skin diseases such as the above mentioned scleroderma
Detailed Description:
Ultraviolet rays from the sun that reach the earth surface are divided into shorter wavelength hence high energy UVB 290-320nm and longer wavelength hence low energy UVA 320-400nm The wavelengths of light that cause sunburn and are associated with skin cancer causation is the high energy UVB UVA wavelengths can be further divided into relatively shorter wavelength hence higher energy UVA2 320-340nm and longer wavelength lower energy UVA1 340-400nm Phototherapy light boxes used in our clinic for the treatment of psoriasis atopic dermatitis and pruritus as well as those used in tanning salons emit both UVB and UVA wavelengths of light The advantages of using UVA1 light source in the treatment of skin conditions are 1 lack of skin cancer and sunburn causing rays UVB and 2 as a consequence the ability to treat patients more safely and longer
Keloid scleroderma acne keloidalis nuchae and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis Treatments for these disabling conditions are inadequate at present Recently in non-controlled studies UVA1 was shown to induce improvement in patients with scleroderma granuloma annulare and urticaria pigmentosa 1-3 The mode of action of UVA1 treatment is not completely understood however local immuno-modulation appears to be important 4 UVA1 has also been shown to stimulate collagenase activity in a dose dependent manner in the dermis 56 We postulate therefore that UVA1 in appropriate doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen
Based on the result of this pilot study a formal controlled clinical investigation is planned
Keloid scleroderma acne keloidalis nuchae and burn scars are all characterized by collagenous thickening of the skin resulting in superficial and deep cutaneous sclerosis Treatments for these disabling conditions are inadequate at present Recently in non-controlled studies UVA1 was shown to induce improvement in patients with scleroderma granuloma annulare and urticaria pigmentosa 1-3 The mode of action of UVA1 treatment is not completely understood however local immuno-modulation appears to be important 4 UVA1 has also been shown to stimulate collagenase activity in a dose dependent manner in the dermis 56 We postulate therefore that UVA1 in appropriate doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen
Based on the result of this pilot study a formal controlled clinical investigation is planned
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