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

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

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 Overview

• Status: Completed
• Conditions: Dry Skin
• Intervention / Treatment: Other: AmLactin® Rapid Relief

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Sandoz Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Sandoz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0123-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No