Clinical trial NCT05779150: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pruritus
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: self-controlled clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: change from baseline effective rate of treatment at 14 days after treatment
timeFrame: baseline and 14 days after treatment
Secondary outcomes:
measure: clinical tolerability score
timeFrame: 1 day, 3 days, 7 days, and 14 days after treatment
measure: product experience score
timeFrame: after 14 days of treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yu Hu, Dr
role: PRINCIPAL_INVESTIGATOR
References: