Efficacy of CeraVe® Moisturizing Cream on Skin Pruritus in Elderly Patients

NCT ID: NCT05779150

Last Updated: 2023-03-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-26

Study Completion Date

2024-02-03

Brief Summary

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The goal of this clinical trial is to evaluate the CeraVe® moisturizing cream's efficiency on the improvement of skin barrier in patients with chronic elderly pruritus. The main questions it aims to answer are:

type of study: clinical trial participant population:in patients with chronic elderly pruritus \[question 1\] Evaluate the CeraVe® moisturizing cream's efficiency on the improvement of skin barrier in patients with chronic elderly pruritus, including improvements of redness, dryness/squamation, itching, burning, tingling, tightness and other factors.

\[question 2\] Evaluate the tolerance of CeraVe® Moisturising Cream. \[question 3\] Evaluate the product experience of patients who were utilizing CeraVe® Moisturising Cream.

This trial utilizing simple randomization, the left and right calves of paticipants were randomly divided into test side(applicating CeraVe® Moisturising Cream ) and control side (applicating Standard Cream)according to random number representation. Grouping results were double-blinded.

Detailed Description

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Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

self-controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Case group

Routine treatment together with once applicating CeraVe® Moisturising Cream after daily bath.

Group Type EXPERIMENTAL

CeraVe® Moisturising Cream

Intervention Type OTHER

CeraVe® Moisturising Cream contains 3 kinds of skin-native ceramides, which can protect the skin against external stimuli, strengthen the damaged skin barrier, fill the intercellular lipids to deeply trap water, relieve dry skin, and increase skin hydration.

Control Group

Routine treatment together with once applicating Standard Cream after daily bath.

Group Type PLACEBO_COMPARATOR

Standard Cream

Intervention Type OTHER

placebo cream

Interventions

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CeraVe® Moisturising Cream

CeraVe® Moisturising Cream contains 3 kinds of skin-native ceramides, which can protect the skin against external stimuli, strengthen the damaged skin barrier, fill the intercellular lipids to deeply trap water, relieve dry skin, and increase skin hydration.

Intervention Type OTHER

Standard Cream

placebo cream

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients age≥60 years old(male or female).
* Clinician evaluates dry pruritus or patient complains of pruritus, which lasts for more than 1 month.
* Patients informed consent to the purpose and content of the research, willing to cooperate with follow-up observation. Have good communication and understanding skills.
* Patients are willing to share photos for medical research purpose.

Exclusion Criteria

* Patients with bacterial and/or viral infections in the acute phase of skin inflammation
* The affected area is complicated by other skin diseases that may affect the efficacy evaluation
* Those who are allergic to the ingredients of this product or with allergic constitution
* Patients who have severe heart, brain, lung, or liver damage.
* Those who have received systemic or local antiallergic drug treatment within 2 weeks before enrollment of this study.
* Those who attending other clinical drug trials within 4 weeks before enrollment of this study.
* Patients with a history of alcohol or drug abuse.
* Patients who are unwilling to sign the informed consent form, and those who are unwilling to cooperate.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Hu, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kuai Zheng, Dr

Role: CONTACT

+86 13621945767

Facility Contacts

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Zheng Kuai, Dr

Role: primary

+86 13621945767

Other Identifiers

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B2023-004

Identifier Type: -

Identifier Source: org_study_id

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