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

Xerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429206
• Other study ID #: SQIN-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 17, 2015
• Last updated: August 19, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Nordic Life Science Pipeline Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Xerosis

Intervention

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).
• standard moisturizing cream (Glaxal Base)

Locations

Country	Name	City	State
Canada	Nordic Life Science Pipeline	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Life Science Pipeline Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin tolerance (Self-assessment of redness or itchiness problems)	Self-assessment of redness or itchiness problems during or after the treatment	14 days	Yes
Primary	Moisturizing level (Self-assessment (5-level score)	Self-assessment (5-level score) of dry skin conditions before, during and after the treatment	14 days	No
Primary	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	14 days	No