Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
Primary Purpose
Xerosis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SQIN
standard moisturizing cream (Glaxal Base)
Sponsored by

About this trial
This is an interventional treatment trial for Xerosis
Eligibility Criteria
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
Sites / Locations
- Nordic Life Science Pipeline
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Positive Control
Experimental Cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Skin tolerance (Self-assessment of redness or itchiness problems)
Self-assessment of redness or itchiness problems during or after the treatment
Moisturizing level (Self-assessment (5-level score)
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
Elasticity level (Self-assessment (5-level score)
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02429206
First Posted
April 17, 2015
Last Updated
August 19, 2015
Sponsor
Nordic Life Science Pipeline Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02429206
Brief Title
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Life Science Pipeline Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positive Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Cream
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SQIN
Other Intervention Name(s)
SQIN on one side - control cream on other side
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
standard moisturizing cream (Glaxal Base)
Primary Outcome Measure Information:
Title
Skin tolerance (Self-assessment of redness or itchiness problems)
Description
Self-assessment of redness or itchiness problems during or after the treatment
Time Frame
14 days
Title
Moisturizing level (Self-assessment (5-level score)
Description
Self-assessment (5-level score) of dry skin conditions before, during and after the treatment
Time Frame
14 days
Title
Elasticity level (Self-assessment (5-level score)
Description
Self-assessment (5-level score) of the elasticity level of the skin before, during and after the treatment
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Guertin, Ph.D.
Organizational Affiliation
Nordic Life Science Pipeline and Laval University
Official's Role
Study Director
Facility Information:
Facility Name
Nordic Life Science Pipeline
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1Y2T4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
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