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
|Condition or disease||Intervention/treatment||Phase|
|Xerosis||Other: SQIN Other: standard moisturizing cream (Glaxal Base)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
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
- 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
- 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
- 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
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
|Nordic Life Science Pipeline|
|Quebec City, Quebec, Canada, G1Y2T4|
|Study Director:||Pierre Guertin, Ph.D.||Nordic Life Science Pipeline and Laval University|