Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers

NCT04185025 | Unknown

• 1 other identifier: v2.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CeraVe Moisturising Lotion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The loss of transdermal water

  0 day, 1 day, 7 days, 14 days, 17 days

• Cuticle moisture

  0 day, 1 day, 7 days, 14 days, 17 days

Study Arms (2)

CeraVe Moisturising Lotion

EXPERIMENTAL

Drug: Ceramides

Half Mu ceramide body milk

ACTIVE COMPARATOR

Drug: Ceramides

Interventions

Ceramides DRUG

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.

CeraVe Moisturising Lotion; Half Mu ceramide body milk

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Ceramides

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Neutral Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 4, 2019
• Study Start: September 20, 2019
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: December 4, 2019

Record last verified: 2019-11

Locations

CN (1)