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

NCT ID: NCT04085809

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-26

Study Completion Date

2019-04-08

Brief Summary

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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

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Conditions

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Dry Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

AmLactin® Rapid Relief

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

AmLactin® Rapid Relief

Intervention Type OTHER

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

Interventions

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AmLactin® Rapid Relief

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sandoz Investigational Site

High Point, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33178384 (View on PubMed)

Other Identifiers

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0123-02-01

Identifier Type: -

Identifier Source: org_study_id

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