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

NCT02429206 | Completed Phase 2

• 1 other identifier: SQIN-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerosis

Outcome Measures

Primary Outcomes (3)

• Skin tolerance (Self-assessment of redness or itchiness problems)

  Self-assessment of redness or itchiness problems during or after the treatment

  14 days

• Moisturizing level (Self-assessment (5-level score)

  Self-assessment (5-level score) of dry skin conditions before, during and after the treatment

  14 days

• 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

Study Arms (2)

Positive Control

ACTIVE COMPARATOR

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 Cream

EXPERIMENTAL

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

Interventions

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).

Also known as: SQIN on one side - control cream on other side

Experimental Cream

standard moisturizing cream (Glaxal Base) OTHER

Positive Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
• Chronically injured (at least 3 months post-injury)
• Paraplegic or tetraplegic
• years of age
• Men and women
• French-speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Life Science Pipeline Inc.: lead

Study Sites (1)

Nordic Life Science Pipeline

Québec, Quebec, G1Y2T4, Canada

Location

Study Officials

• Pierre Guertin, Ph.D.

  Nordic Life Science Pipeline and Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

CA (1)