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Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis

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ClinicalTrials.gov Identifier: NCT02429206
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Nordic Life Science Pipeline Inc.

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.

Condition or disease Intervention/treatment Phase
Xerosis Other: SQIN Other: standard moisturizing cream (Glaxal Base) Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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.
Other: standard moisturizing cream (Glaxal Base)
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.
Other: SQIN
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 Name: SQIN on one side - control cream on other side




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429206


Locations
Canada, Quebec
Nordic Life Science Pipeline
Quebec City, Quebec, Canada, G1Y2T4
Sponsors and Collaborators
Nordic Life Science Pipeline Inc.
Investigators
Study Director: Pierre Guertin, Ph.D. Nordic Life Science Pipeline and Laval University

Responsible Party: Nordic Life Science Pipeline Inc.
ClinicalTrials.gov Identifier: NCT02429206     History of Changes
Other Study ID Numbers: SQIN-01
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms