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

NCT05779150 | Unknown DMC

• 1 other identifier: B2023-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

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

  1. According to Nimodipine calculation: Treatment Index = (Self-assessment parameters after treatment - Self-assessment parameters before treatment)/Self-assessment parameters before treatment\*100% 2. 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% 3. Effective rate of treatment = (Cure + Significant recovery)/total\*100%

  baseline and 14 days after treatment

Secondary Outcomes (2)

• clinical tolerability score

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

• product experience score

  after 14 days of treatment

Study Arms (2)

Case group

EXPERIMENTAL

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

Other: CeraVe® Moisturising Cream

Control Group

PLACEBO COMPARATOR

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

Other: Standard Cream

Interventions

CeraVe® Moisturising Cream 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.

Case group

Standard Cream OTHER

placebo cream

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu Hu, Dr

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuai Zheng, Dr

CONTACT

+86 13621945767; kuai.zheng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: self-controlled clinical trial

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 22, 2023
• Study Start: February 26, 2023
• Primary Completion: June 30, 2023
• Study Completion: February 3, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)