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

NCT04085809 | Completed

• 1 other identifier: 0123-02-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in overall dry skin scale

  Baseline, Day 2, Day 14

• Change from baseline in Skin Dryness assessed by Dry Skin Scale

  Baseline, Day 2, Day 14

• Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale

  Baseline, Day 2, Day 14

• Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale

  Baseline, Day 2, Day 14

• Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale

  Baseline, Day 2, Day 14

Study Arms (2)

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

Other: AmLactin® Rapid Relief

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

Other: AmLactin® Rapid Relief

Interventions

AmLactin® Rapid Relief OTHER

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

Left Leg: AmLactin® Rapid Relief / Right Leg: No Treatment; Left Leg: No Treatment / Right Leg: AmLactin® Rapid Relief

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Only female participants were being studied
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigational Site

High Point, North Carolina, 27262, United States

Location

Related Publications (1)

• 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.

  PMID: 33178384 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: March 26, 2019
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)