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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CeraVe® Moisturising Cream

Standard Cream

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan Hospital,Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Case group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05779150

First Posted

March 4, 2023

Last Updated

March 19, 2023

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05779150

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 26, 2023 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

February 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pruritus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

self-controlled clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Case group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

CeraVe® Moisturising Cream

Intervention Description

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

Intervention Name(s)

Standard Cream

Intervention Description

placebo cream

Primary Outcome Measure Information:

Title

change from baseline effective rate of treatment at 14 days after treatment

Description

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%

Time Frame

baseline and 14 days after treatment

Secondary Outcome Measure Information:

Title

clinical tolerability score

Description

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.

Time Frame

1 day, 3 days, 7 days, and 14 days after treatment

Title

product experience score

Description

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.

Time Frame

after 14 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kuai Zheng, Dr

Phone

+86 13621945767

Email

kuai.zheng@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu Hu, Dr

Organizational Affiliation

Shanghai Zhongshan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital,Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zheng Kuai, Dr

Phone

+86 13621945767

Email

kuai.zheng@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Yu Hu, Dr

12. IPD Sharing Statement

Plan to Share IPD

No

Pruritus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial