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Completed

NCT Number: NCT02429206

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nordic Life Science Pipeline

Québec, Quebec, G1Y2T4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SQIN

Other

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: SQIN on one side - control cream on other side

standard moisturizing cream (Glaxal Base)

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nordic Life Science Pipeline Inc.

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Aug 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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