Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129428
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2005-08-09
Brief Title:
Ultraviolet B UVB Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix An Open Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study will evaluate the effectiveness of high dose UVB light therapy in the treatment of keloid or hypertrophic scar scleroderma acne keloidalis nuchae old burn scars granuloma annulare or related conditions
Detailed Description:
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
However UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases MMPs The investigators preliminary data show that high dose UVB 160 mJcm2 will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs They postulate therefore that in pigmented skin higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways
The purpose of this research project is to study the effectiveness of high dose UVB 290-320nm at up to 320mJcm2 irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation These disorders include but are not limited to keloid or hypertrophic scar scleroderma acne keloidalis nuchae old burn scars and granuloma annulare Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week for 16 weeks
However UVA1 is unable to penetrate pigmented skin at an effective level to activate matrix metalloproteinases MMPs The investigators preliminary data show that high dose UVB 160 mJcm2 will penetrate pigmented skin and activate the cellular pathways necessary to stimulate MMPs They postulate therefore that in pigmented skin higher than usual UVB doses can improve these fibrosing skin conditions safely through collagenase-mediated removal of excess dermal collagen via activation of MMP pathways
The purpose of this research project is to study the effectiveness of high dose UVB 290-320nm at up to 320mJcm2 irradiation for the treatment of skin conditions with altered dermal matrix in patients with increased skin pigmentation These disorders include but are not limited to keloid or hypertrophic scar scleroderma acne keloidalis nuchae old burn scars and granuloma annulare Up to fifty patients with one of these diagnoses or related conditions will receive UVB irradiation up to 5 times per week for 16 weeks
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