Raynaud Phenomenon Clinical Trial
Official title:
Localized Effects of Photobiomodulation and Exogenous Nitric Oxide on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
Background CREST is an acronym for the cardinal clinical features of the syndrome
(Calcinosis, Raynaud phenomenon, Esophageal dysmotility, Sclerodactyly, and Telangiectasia)
and part of the heterogeneous group of sclerodermas.
Calcinosis is the pathologic calcification of soft tissues. When symptomatic, they can be
tender and painful, ulcerate, and drain a white chalky substance. With time, heterotopic bone
formation may occur. Inflammatory reactions also intermittently occur at the site of
calcinosis. It has been suggested that TGF-beta3 plays a major role in the pathogenesis of
calcinosis.
A variety of medical therapies have been used to try to alleviate patient symptoms. These
include pharmacological approaches (e..g., warfarin), surgical curettage or excision, as well
as carbon dioxide laser treatments. No consistently reliable pharmacological treatment seems
to be available to prevent or eliminate calcinosis. Curettage and excision and carbon dioxide
laser of localized painful large deposits can relieve symptoms but recurrence is common. In
addition, aggressive curettage or excision can damage deeper neurovascular structures. While
calcinosis is associated with significant morbidity its treatment remains a challenge.
Photobiomodulation (PBM) has been shown to promote wound healing, suppress inflammatory
reactions and regulate collagen synthesis in a number of in vitro and in vivo studies.
Human skin contains photolabile nitric oxide (NO) derivatives which decompose after UVA
irradiation and release vasoactive NO. However, aside from blue light, barely nothing has
been reported about the effects of red and NIR wavelengths.
Method A custom-built air tight sleeve which envelopes the forearm of a subject will be used
to measure the NO emanating from the skin under photobiomodulation conditions (red & NIR) and
quantified by chemiluminescence detection.
Simultaneously, CREST patient's hands exhibiting calcinosis and/or Raynaud phenomenon will be
exposed to exogenous gaseous nitric oxide (INOMAX) to determine the vascular impact of this
approach.
This case series will assess Light Emitting Diode (LED) based PBM therapy as a treatment
alternative for cutaneous calcinosis and the effects of gaseous NO on calcinosis and/or
Raynaud phenomenon in CREST patients.
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