Clinical trial NCT03972566: Localized Effects of PBM and Exogenous NO on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
Official title: Localized Effects of Photobiomodulation and Exogenous Nitric Oxide on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CREST Syndrome
Calcinosis Cutis
Raynaud Phenomenon
Keywords: Nitric Oxide
Photobiomodulation
LLLT
Photomedicine
Lead sponsor: RoseLab Skin Optics Laboratory
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2019-06-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from CREST that have consulted in Dr. Barolet's Clinic of Dermatology

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-60 years of age
* CREST syndrome with calcinosis cutis.
* CREST syndrome without calcinosis cutis.

Exclusion Criteria:

* Diabetes mellitus
* Acute inflammation
* Arrhythmia
* Acute malignancy
* Renal failure
* Active CVD
* Photodermatosis and/or photosensitivity including skin cancer-prone disease/syndrome (XP and Bloom Syndrome)
* Porphyria and/or hypersensitivity to porphyrins
* Congenital or acquired immunodeficiency.

Primary outcomes:
measure: Chemiluminescence detection
timeFrame: 15 minutes
measure: Endothelial Measurement
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Clinique Dr Daniel Barolet
state: Quebec
Study officials:
References: