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

Dry Skin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085809
• Other study ID #: 0123-02-01
• Status: Completed
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: April 8, 2019

Study information

• Verified date: May 2023
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Skin

Intervention

Other:
• AmLactin® Rapid Relief
AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.

Locations

Country	Name	City	State
United States	Sandoz Investigational Site	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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