CREST SyndromeNCT03972566
Localized Effects of PBM and Exogenous NO on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
An observational study of CREST Syndrome and Calcinosis Cutis, run by RoseLab Skin Optics Laboratory at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- CREST Syndrome, Calcinosis Cutis, Raynaud Phenomenon
- What is being tested?
- INOMAX
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2019to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients suffering from CREST that have consulted in Dr. Barolet's Clinic of Dermatology
Who may be able to join
- Male or female
- 18-60 years of age
- CREST syndrome with calcinosis cutis.
- CREST syndrome without calcinosis cutis.
Who cannot join
- Diabetes mellitus
- Acute inflammation
- Arrhythmia
- Acute malignancy
- Renal failure
- Active CVD
Show all 9Show fewer
- Photodermatosis and/or photosensitivity including skin cancer-prone disease/syndrome (XP and Bloom Syndrome)
- Porphyria and/or hypersensitivity to porphyrins
- Congenital or acquired immunodeficiency.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique Dr Daniel Barolet
Laval, Quebec, H7T0G3
Daniel Barolet, MD, 450-686-4744, daniel.barolet@mcgill.ca
Augustin Barolet, B.Eng, 450-686-4744, augustin.barolet@mail.mcgill.ca
About this study
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.
Read more
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.
- Conditions
- CREST Syndrome, Calcinosis Cutis, Raynaud Phenomenon
- Being tested
- INOMAX
- Keywords
- Nitric Oxide, Photobiomodulation, LLLT, Photomedicine
- Medical subject headings
- CREST Syndrome, Calcinosis Cutis, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOMAXDrug
INOMAX + PBM
| Study group | Role | What they receive |
|---|---|---|
| CREST with Calcinosis cutis | Not described Receives: Drug: INOMAX | |
| CREST without Calcinosis cutis | Not described Receives: Drug: INOMAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemiluminescence detection
Sievers Nitric Oxide Analyzer NOA 280i detects [NO] in Ambient Air or Solution
Measured: 15 minutes
Endothelial Measurement
VENDYS II
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start20 Jun 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CREST SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RoseLab Skin Optics Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Dr Daniel Barolet, RoseLab Skin Optics Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972566
- Sponsor's protocol ID
- NO-5420
- Status last verified
- May 2019
- First submitted
- 30 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Effects of Photobiomodulation and Exogenous Nitric Oxide on CREST Patients Calcinosis Cutis & Raynaud Phenomenon
- ClinicalTrials.gov ID
- NCT03972566
- Acronym / sponsor ID
- NO-5420
- Conditions
- CREST Syndrome, Calcinosis Cutis, Raynaud Phenomenon
- Keywords
- Nitric Oxide, Photobiomodulation, LLLT, Photomedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- RoseLab Skin Optics LaboratoryUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CREST with Calcinosis cutis | – | Drug: INOMAX |
| CREST without Calcinosis cutis | – | Drug: INOMAX |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients suffering from CREST that have consulted in Dr. Barolet's Clinic of Dermatology
Key inclusion criteria (4 listed)
- Male or female
- 18-60 years of age
- CREST syndrome with calcinosis cutis.
- CREST syndrome without calcinosis cutis.
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Acute inflammation
- Arrhythmia
- Acute malignancy
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INOMAXINOMAX + PBM | Drug | CREST with Calcinosis cutis, CREST without Calcinosis cutis |
Primary outcome
Chemiluminescence detection
Time frame: 15 minutes
Sievers Nitric Oxide Analyzer NOA 280i detects [NO] in Ambient Air or Solution
Endothelial Measurement
Time frame: 5 minutes
VENDYS II
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CREST Syndrome and Calcinosis Cutis, run by RoseLab Skin Optics Laboratory at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Barolet, MD (450-686-4744, daniel.barolet@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemiluminescence detection (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.