This Was a Clinical Study Investigating the Moisturization and Desquamation Effect of AmLactin® Rapid Relief Restoring Lotion + Ceramides on Dry Skin in Healthy Female Volunteers. AmLactin® Rapid Relief is an Over-the-counter Cosmetic

Study Overview
=================
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.

Official Title
-----------------
A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and Desquamation of AmLactin® Rapid Relief Treatment in Healthy Female Subjects

Conditions
-----------------
Dry Skin

Intervention / Treatment
-----------------
* Other: AmLactin® Rapid Relief


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment<br>AmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg | Other: AmLactin® Rapid Relief<br>* AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.<br>|
| Experimental: Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief<br>AmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg | Other: AmLactin® Rapid Relief<br>* AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |