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

Not Applicable

Completed

• Conditions: Dry Skin
• Interventions: Other: AmLactin® Rapid Relief

• Registration Number: NCT04085809
• Lead Sponsor: Sandoz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief	AmLactin® Rapid Relief	AmLactin® Rapid Relief, BID application for 14 days on right leg and no treatment on left leg
Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment	AmLactin® Rapid Relief	AmLactin® Rapid Relief, BID application for 14 days on left leg and no treatment on right leg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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.

Trial Locations

Locations (1)

Sandoz Investigational Site; 🇺🇸 High Point, North Carolina, United States