The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.
Sandoz Investigational Site
High Point, North Carolina, United States
Change from baseline in D-SQUAME
D-SQUAME is a sticky tape that is placed on the skin and the more skin that comes off on the tape, the drier the skin and less moisturization and desquamation.
Time frame: Baseline, Day 2, Day 14
Change from baseline in overall dry skin scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe in five domains.
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Dryness assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Time frame: Baseline, Day 2, Day 14
Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Time frame: Baseline, Day 2, Day 14
Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
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Time frame: Baseline, Day 2, Day 14
Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale
An evaluation of the skin by a blinded Investigator was utilized to assess the overall appearance of the skin on an ordinal scale from 0 = none to 4 = severe.
Time frame: Baseline, Day 2, Day 14
Change from baseline in Subject Self-Assessment Questionnaire
Subjects rated the skin attributes of the treated leg in nine domains on a scale from 0 - 4 .
Time frame: Baseline, Day 14