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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment | Experimental | AmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg |
|
| Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief | Experimental | AmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AmLactin® Rapid Relief | Other | AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 2, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 2, Day 14 |
| Change from baseline in Skin Dryness assessed by Dry Skin Scale |
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Inclusion Criteria:
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
Only female participants were being studied
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoz Investigational Site | High Point | North Carolina | 27262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33178384 | Derived | Draelos ZD, Hall S, Munsick C. A 14-day Controlled Study Assessing Qualitative Improvement with 15% Lactic Acid and Ceramides in Skin Moisturization and Desquamation. J Clin Aesthet Dermatol. 2020 Aug;13(8):E54-E58. Epub 2020 Aug 1. |
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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.
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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. |
| 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. | 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. | 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. | 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. | 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 . | Baseline, Day 14 |