Dry Skin
Conditions
Brief summary
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.
Interventions
OTHERAmLactin® Rapid Relief
AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.
Sponsors
Sandoz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Upon enrollment, each subject received a randomization code, indicating which leg the study product had to be applied (the other leg received no study product). Each subject in this study served as her own control.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy female (confirmed by medical history) with Fitzpatrick skin types I-VI * dry, rough skin on the anterior shins (defined as Grade 3-4 on the dermatologist evaluation of the skin);
Exclusion criteria
\- Had any visible skin disease at the assessment site which, in the opinion of the Investigator, would interfere with the evaluation of the test site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in D-SQUAME | Baseline, Day 2, Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Skin Dryness assessed by Dry Skin Scale | Baseline, Day 2, Day 14 | 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. |
| Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale | Baseline, Day 2, Day 14 | 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. |
| Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale | Baseline, Day 2, Day 14 | 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. |
| Change from baseline in overall dry skin scale | Baseline, Day 2, Day 14 | 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. |
| Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale | Baseline, Day 2, Day 14 | 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. |
| Change from baseline in Subject Self-Assessment Questionnaire | Baseline, Day 14 | Subjects rated the skin attributes of the treated leg in nine domains on a scale from 0 - 4 . |
| Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale | Baseline, Day 2, Day 14 | 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. |
Countries
United States
Outcome results
None listed