PruritusNCT05779150
Efficacy of CeraVe® Moisturizing Cream on Skin Pruritus in Elderly Patients
A study testing CeraVe® Moisturising Cream and Standard Cream in people with Pruritus, run by Shanghai Zhongshan Hospital at 1 site in China.
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]… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pruritus
- What is being tested?
- CeraVe® Moisturising Cream and Standard Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2023to 3 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032
Zheng Kuai, Dr, +86 13621945767, kuai.zheng@zs-hospital.sh.cn
Yu Hu, Dr
About this study
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.
Read more
[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
- Being tested
- CeraVe® Moisturising Cream, Standard Cream
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe® Moisturising CreamOther
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 CreamOther
placebo cream
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Routine treatment together with once applicating CeraVe® Moisturising Cream after daily bath. Receives: Other: CeraVe® Moisturising Cream |
| Control Group | Placebo comparator | Routine treatment together with once applicating Standard Cream after daily bath. Receives: Other: Standard Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: baseline and 14 days after treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: after 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start26 Feb 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion3 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- self-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Hu, Dr, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779150
- Sponsor's protocol ID
- B2023-004
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CeraVe® Moisturizing Cream on Skin Pruritus in Elderly Patients
- ClinicalTrials.gov ID
- NCT05779150
- Acronym / sponsor ID
- B2023-004
- Conditions
- Pruritus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 26 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 3 Feb 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- self-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Other: CeraVe® Moisturising CreamRoutine treatment together with once applicating CeraVe® Moisturising Cream after daily bath. |
| Control Group | Placebo comparator | Other: Standard CreamRoutine treatment together with once applicating Standard Cream after daily bath. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraVe® Moisturising CreamCeraVe® 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. | Other | Case group |
| Standard Creamplacebo cream | Other | Control Group |
Primary outcome
change from baseline effective rate of treatment at 14 days after treatment
Time frame: baseline and 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%
2 secondary outcomes
clinical tolerability score
Time frame: 1 day, 3 days, 7 days, and 14 days after treatment
product experience score
Time frame: after 14 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Hu, Dr principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraVe® Moisturising Cream and Standard Cream in people with Pruritus, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuai Zheng, Dr (+86 13621945767, kuai.zheng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline effective rate of treatment at 14 days after treatment (time frame: baseline and 14 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.