Keloid Clinical Trial
Official title:
The Effectiveness of UVB Irradiation in the Treatment of Skin Conditions With Altered Dermal Matrix: An Open Pilot Study
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.
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
mJ/cm2) 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 320mJ/cm2) 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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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