Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers

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

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

Conditions
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CeraVe Moisturising Lotion

Intervention / Treatment
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* Drug: Ceramides


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CeraVe Moisturising Lotion<br> | Drug: Ceramides<br>* 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.<br>|
| Active Comparator: Half Mu ceramide body milk<br> | Drug: Ceramides<br>* 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.<br>|

What is the study measuring?
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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 |