Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers

Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers: A Double-blind, Randomized, Controlled Trial

This study aims to evaluate the improvement of CeraVe moisturising lotion on the cuticle moisture of dry skin and barrier repair function.

Study Overview

• Status: Unknown
• Conditions: CeraVe Moisturising Lotion
• Intervention / Treatment: Drug: Ceramides

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University First Hospital
    • Contact: Yan Wu; Phone Number: +86-13910978643; Email: amy60436@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Those who volunteer to participate in the trial, sign the informed consent, be able to cooperate with follow-up observation, and conduct the trial according to the guidance of the doctor.
• Dry skin subjects with symmetrical distribution of forearm flexion diagnosed by a doctor.
• Those who are 30-80 years old, male or female.
• Those with good compliance who can not use other external drugs during the entire observation period.

Exclusion Criteria:

• Those who do not sign the informed consent.
• Those with the history of allergies to test product and control product ingredients.
• Those who received or are receiving medical or physical therapy for any skin or systemic disease recently (≤3 months)
• Those who have a large amount of exudation in the acute phase or who are infected at the test site.
• Female subjects who are preparing for pregnancy, pregnancy, lactation, or within six months after delivery.
• Those who participate in clinical trials of other moisturizing products or emollients.
• Those who are taking other oral medicines that affect the skin condition.
• Those who the investigator considers unsuitable for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CeraVe Moisturising Lotion	Drug: Ceramides; On the 0th day, it is determined that one of the leg extensions of the participant is the test side using CeraVe Moisturising Lotion and the opposite side is the control side using Half Mu ceramide body milk by the random table. Participants are required to use the product in the morning and evening according to the "Product Use Procedures", during which other moisturizing products or emollients are prohibited. And the follow-up tests are conducted at the prescribed time. At each visit, empty packaging of products used during this period must be collected; if they are not used up as required, the remaining products must be collected.
Active Comparator: Half Mu ceramide body milk	Drug: Ceramides; On the 0th day, it is determined that one of the leg extensions of the participant is the test side using CeraVe Moisturising Lotion and the opposite side is the control side using Half Mu ceramide body milk by the random table. Participants are required to use the product in the morning and evening according to the "Product Use Procedures", during which other moisturizing products or emollients are prohibited. And the follow-up tests are conducted at the prescribed time. At each visit, empty packaging of products used during this period must be collected; if they are not used up as required, the remaining products must be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-assessment from patients	The patients fill out questionnaires and score erythema, desquamation, dryness, itching, and cleft palate on both sides of the calves (0 = none, 1 = light, 2 = medium, 3 = severe).	17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The loss of transdermal water	The percutaneous water loss value of the test site is measured continuously in an open chamber with Tewameter (TM300, Courage and Khazaka, Germany), and the measurement is performed 3 times continuously. The average value is taken after the value is stable.	0 day, 1 day, 7 days, 14 days, 17 days
Cuticle moisture	The water content in the stratum corneum of the test site is measured 5 times with Corneometer (CM825, Course and Khazaka, Germany) and the average value is taken.	0 day, 1 day, 7 days, 14 days, 17 days

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: November 29, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: V2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No