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OpenTrials
Completed

NCT Number: NCT04085809

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

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.

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Key information

Conditions

Dry Skin

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sandoz Investigational Site

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AmLactin® Rapid Relief

Other

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

Primary outcomes

  1. Change from baseline in D-SQUAME

    Time frame: 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 outcomes

  1. Change from baseline in overall dry skin scale

    Time frame: 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.

  2. Change from baseline in Skin Dryness assessed by Dry Skin Scale

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale

    Time frame: 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.

  7. Change from baseline in Subject Self-Assessment Questionnaire

    Time frame: Baseline, Day 14

    Subjects rated the skin attributes of the treated leg in nine domains on a scale from 0 - 4 .

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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