- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02429206
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
August 19, 2015 updated by: Nordic Life Science Pipeline Inc.
Prospective, Double Blind, Randomized Phase II/III Study to Assess the Safety and Efficacy of SQIN™ on Xerosis in Adults Suffering of Mobility Impairment and/or Complete Paralysis Associated With Chronic Spinal Cord Injury.
In the general population, xerosis is often caused by external factors such as seasonal changes.
In that case, the best way to relieve dry skin is to use a standard moisturizer.
However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems.
This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Xerosis is a medical term for dry skin.
When it results in skin that is scaly and itchy, the condition is called pruritus.
This occurs when natural moisture is drawn out of the skin.
The skin needs moisture to protect itself.
The best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers.
However, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones).
SQIN with CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects.
Based upon preliminary evidence, SQIN with CanSATs technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Quebec City, Quebec, Canada, G1Y2T4
- Nordic Life Science Pipeline
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
- Chronically injured (at least 3 months post-injury)
- Paraplegic or tetraplegic
- 18-75 years of age
- Men and women
- French-speaking
Exclusion Criteria:
- Acute or subacute stage (within 1 day and 3 months post-injury)
- Had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years
- Allergic or hypersensitive to any ingredient, investigational or control product
- With psychiatric or mental disorder(s)
- Children (younger than 18 year-old) or elderly (older than 75 year-old)
- Not French-speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Positive Control
Each volunteer will be asked to self-apply a standard moisturizing cream (Glaxal Base) on one side of their body.
Application twice a day during 14 days.
|
|
Experimental: Experimental Cream
Each volunteer will be asked to self-apply the experimental product (SQIN with CanSATs technology) on the other side of their body.
Application twice a day during 14 days.
|
Each patient will be asked to self-apply both creams (experimental vs positive control) on the right and left sides of their body (sides will be randomly assigned).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin tolerance (Self-assessment of redness or itchiness problems)
Time Frame: 14 days
|
Self-assessment of redness or itchiness problems during or after the treatment
|
14 days
|
Moisturizing level (Self-assessment (5-level score)
Time Frame: 14 days
|
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
|
14 days
|
Elasticity level (Self-assessment (5-level score)
Time Frame: 14 days
|
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Pierre Guertin, Ph.D., Nordic Life Science Pipeline and Laval University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
April 17, 2015
First Submitted That Met QC Criteria
April 28, 2015
First Posted (Estimate)
April 29, 2015
Study Record Updates
Last Update Posted (Estimate)
August 20, 2015
Last Update Submitted That Met QC Criteria
August 19, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SQIN-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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