CeraVe Moisturising LotionNCT04185025
Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers
A study testing Ceramides in people with CeraVe Moisturising Lotion, run by Peking University First Hospital at 1 site in China.
Trial summary
This study aims to evaluate the improvement of CeraVe moisturising lotion on the cuticle moisture of dry skin and barrier repair function. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- CeraVe Moisturising Lotion
- What is being tested?
- Ceramides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2019to Jan 2020
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who volunteer to participate in the trial, sign the informed consent, be able to cooperate with follow-up observation, and conduct the trial according to the guidance of the doctor.
- Dry skin subjects with symmetrical distribution of forearm flexion diagnosed by a doctor.
- Those who are 30-80 years old, male or female.
- Those with good compliance who can not use other external drugs during the entire observation period.
Who cannot join
- Those who do not sign the informed consent.
- Those with the history of allergies to test product and control product ingredients.
- Those who received or are receiving medical or physical therapy for any skin or systemic disease recently (≤3 months)
- Those who have a large amount of exudation in the acute phase or who are infected at the test site.
- Female subjects who are preparing for pregnancy, pregnancy, lactation, or within six months after delivery.
- Those who participate in clinical trials of other moisturizing products or emollients.
- Those who are taking other oral medicines that affect the skin condition.
- Those who the investigator considers unsuitable for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Yan Wu, +86-13910978643, amy60436@163.com
About this study
Official title: Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers: A Double-blind, Randomized, Controlled Trial
This study aims to evaluate the improvement of CeraVe moisturising lotion on the cuticle moisture of dry skin and barrier repair function.
- Conditions
- CeraVe Moisturising Lotion
- Being tested
- Ceramides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeramidesDrug
On the 0th day, it is determined that one of the leg extensions of the participant is the test side using CeraVe Moisturising Lotion and the opposite side is the control side using Half Mu ceramide body milk by the random table. Participants are required to use the product in the morning and evening according to the "Product Use Procedures", during which other moisturizing products or emollients are prohibited. And the follow-up tests are conducted at the prescribed time. At each visit, empty packaging of products used during this period must be collected; if they are not used up as required, the remaining products must be collected.
| Study group | Role | What they receive |
|---|---|---|
| CeraVe Moisturising Lotion | Experimental | Not described Receives: Drug: Ceramides |
| Half Mu ceramide body milk | Active comparator | Not described Receives: Drug: Ceramides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessment from patients
The patients fill out questionnaires and score erythema, desquamation, dryness, itching, and cleft palate on both sides of the calves (0 = none, 1 = light, 2 = medium, 3 = severe).
Measured: 17 days
Secondary outcomes (2)
The loss of transdermal water
The percutaneous water loss value of the test site is measured continuously in an open chamber with Tewameter (TM300, Courage and Khazaka, Germany), and the measurement is performed 3 times continuously. The average value is taken after the value is stable.
Measured: 0 day, 1 day, 7 days, 14 days, 17 days
Cuticle moisture
The water content in the stratum corneum of the test site is measured 5 times with Corneometer (CM825, Course and Khazaka, Germany) and the average value is taken.
Measured: 0 day, 1 day, 7 days, 14 days, 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start20 Sep 2019
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CeraVe Moisturising LotionStudies of the same condition, open and under way.
- More trials run by Peking University First 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Wu, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185025
- Sponsor's protocol ID
- v2.0
- Status last verified
- Nov 2019
- First submitted
- 29 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Skin Barrier Repair Function of Two Ceramide Containing Moisturizers: A Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04185025
- Acronym / sponsor ID
- v2.0
- Conditions
- CeraVe Moisturising Lotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 4 Dec 2019 (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.
This study aims to evaluate the improvement of CeraVe moisturising lotion on the cuticle moisture of dry skin and barrier repair function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CeraVe Moisturising Lotion | Experimental | Drug: Ceramides |
| Half Mu ceramide body milk | Active comparator | Drug: Ceramides |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who volunteer to participate in the trial, sign the informed consent, be able to cooperate with follow-up observation, and conduct the trial according to the guidance of the doctor.
- Dry skin subjects with symmetrical distribution of forearm flexion diagnosed by a doctor.
- Those who are 30-80 years old, male or female.
- Those with good compliance who can not use other external drugs during the entire observation period.
Key exclusion criteria (8 listed)
- Those who do not sign the informed consent.
- Those with the history of allergies to test product and control product ingredients.
- Those who received or are receiving medical or physical therapy for any skin or systemic disease recently (≤3 months)
- Those who have a large amount of exudation in the acute phase or who are infected at the test site.
- Female subjects who are preparing for pregnancy, pregnancy, lactation, or within six months after delivery.
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 |
|---|---|---|
| CeramidesOn the 0th day, it is determined that one of the leg extensions of the participant is the test side using CeraVe Moisturising Lotion and the opposite side is the control side using Half Mu ceramide body milk by the random table. Participants are required to use the product in the morning and evening according to the "Product Use Procedures", during which other moisturizing products or emollients are prohibited. And the follow-up tests are conducted at the prescribed time. At each visit, empty packaging of products used during this period must be collected; if they are not used up as required, the remaining products must be collected. | Drug | CeraVe Moisturising Lotion, Half Mu ceramide body milk |
Primary outcome
Self-assessment from patients
Time frame: 17 days
The patients fill out questionnaires and score erythema, desquamation, dryness, itching, and cleft palate on both sides of the calves (0 = none, 1 = light, 2 = medium, 3 = severe).
2 secondary outcomes
The loss of transdermal water
Time frame: 0 day, 1 day, 7 days, 14 days, 17 days
Cuticle moisture
Time frame: 0 day, 1 day, 7 days, 14 days, 17 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceramides in people with CeraVe Moisturising Lotion, run by Peking University First 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 4 Dec 2019. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessment from patients (time frame: 17 days). 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 4 Dec 2019.