Clinical trial NCT02429206: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Xerosis
Lead sponsor: Nordic Life Science Pipeline Inc.
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Skin tolerance (Self-assessment of redness or itchiness problems)
timeFrame: 14 days
measure: Moisturizing level (Self-assessment (5-level score)
timeFrame: 14 days
measure: Elasticity level (Self-assessment (5-level score)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Nordic Life Science Pipeline
state: Quebec
Study officials:
affiliation: Nordic Life Science Pipeline and Laval University
name: Pierre Guertin, Ph.D.
role: STUDY_DIRECTOR
References: