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

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.

Study Overview

• Status: Recruiting
• Conditions: Pruritus
• Intervention / Treatment: Other: CeraVe® Moisturising Cream; Other: Standard Cream

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kuai Zheng, Dr; Phone Number: +86 13621945767; Email: kuai.zheng@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital,Fudan University
      • Contact: Zheng Kuai, Dr; Phone Number: +86 13621945767; Email: kuai.zheng@zs-hospital.sh.cn
      • Principal Investigator: Yu Hu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; Routine treatment together with once applicating CeraVe® Moisturising Cream after daily bath.	Other: 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.
Placebo Comparator: Control Group; Routine treatment together with once applicating Standard Cream after daily bath.	Other: Standard Cream; placebo cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline effective rate of treatment at 14 days after treatment	According to Nimodipine calculation: Treatment Index = (Self-assessment parameters after treatment - Self-assessment parameters before treatment)/Self-assessment parameters before treatment*100%; Definition:Cure: No symptoms, Treatment index > 95% Significant Recovery: symptoms are significantly relieved, 70% <Treatment index≤95% Improved: Symptoms improved, 30%≤Treatment index≤70% No effect: No change in symptoms, Treatment index <30%; Effective rate of treatment = (Cure + Significant recovery)/total*100%	baseline and 14 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical tolerability score	The clinical tolerability score mainly evaluates the objective parameters and subjective parameters. Objective parameters include rash, edema, redness, dryness/desquamation, desquamation, and other superficial signs, and each individual item is scored on a scale of 0 to 3 (level 0 is none, level 1 is slight, level 2 is obvious, level 3 is serious ); Subjective parameters include burning, tingling, itching, tightness, tingling, and other Follow upnctional manifestations, and each individual item is scored on a scale of 0 to 3 (level 0 is none, level 1 is slight, level 2 is obvious, level 3 level is serious); The clinical tolerability score is the average of objective parameters and subjective parameters, which is calculated by the sum of 6 objective parameters and 6 subjective parameters divided by 12.	1 day, 3 days, 7 days, and 14 days after treatment
product experience score	the evaluation includes: improvement in overall skin appearance, product's texture, convenience of product, applicating texture, product's envelopment, product's absorption, product's rub feeling on skin, product's gentleness on skin, product's comfort on skin, product's greasy feeling, product's suitable for skin, product's overall delight, those 12 aspects will be express on 1-5 score scale(1: Completely Disagree; 2:Somewhat disagree;3:neither agree nor disagree;4:somewhat agree;5:completely Agree). The product experience score is the average of those 12 aspects, calculate by the sum of 12 aspects rating divided by 12.	after 14 days of treatment

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Yu Hu, Dr, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): February 3, 2024

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: B2023-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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