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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779150
• Other study ID #: B2023-004
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2023
• Est. completion date: February 3, 2024

Study information

• Verified date: March 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Kuai Zheng, Dr
• Phone: +86 13621945767
• Email: kuai.zheng[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 3, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus

Intervention

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.
• Standard Cream
placebo cream

Locations

Country	Name	City	State
China	Zhongshan Hospital,Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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% Effective rate of treatment = (Cure + Significant recovery)/total*100%	baseline and 14 days after treatment
Secondary	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
Secondary	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