Skin HealthNCT05861622
Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
A study testing Moisturizer in people with Skin Health, run by Thu Brulé at 1 site in United States.
Trial summary
Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture, skin is unlikely to have the properties most commonly associated with healthy skin. Recent research has recently highlighted that rambutan extract, niacinamide, and glycoin can all help promote skin moisture and health. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 30 Jan 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 30-80.
- Frequently experience dry skin.
- Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication or over-the-counter products (e.g., Adapalene/Differin)
- Must be in good health with no unstable, uncontrolled health conditions.
- Must follow a stable, consistent dietary regimen.
- May experience hyperpigmentation and dark spots.
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- Must be willing to maintain the following daily skincare routine: Daily cleansing, test product, and sunscreen that is at least SPF 30
- Must discontinue retinoids four weeks before the study start date and not use retinoids during the trial.
- Must be willing to communicate in English.
- Must be willing to use the test product as directed (twice daily)
- Must be willing to come to the Citruslabs office in Santa Monica, California at the beginning and end of the study.
Who cannot join
- Females who are pregnant or breastfeeding
- Currently participating in another research study.
- Currently using oral retinoids.
- Individuals with self-reported very oily skin.
- Individuals with cystic acne or otherwise very acne-prone skin.
- Anyone using oral acne treatments (e.g., accutane).
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- Anyone prone to experiencing strong bouts of hormonal acne.
- Anyone using prescription medication relevant to the skin.
- Undergoing any cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
- Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (e.g., retinoids)
- Anyone with learning and/or cognitive difficulties that prevent him/her from reading and understanding questionnaires and surveys (e.g., dementia)
- Severe chronic conditions, including oncological conditions or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture, skin is unlikely to have the properties most commonly associated with healthy skin. Recent research has recently highlighted that rambutan extract, niacinamide, and glycoin can all help promote skin moisture and health. To help people experience better skin health, Thu Brulé has developed a serum designed to be used twice daily. Specifically, the test product in this trial was designed to help moisturize the skin and help lock in that moisture. The purpose of this trial is to examine the efficacy of the test product across an eight-week hybrid trial. The outcomes of interest include participants' perceptions of skin health and photographs/images taken of the skin.
- Conditions
- Skin Health
- Being tested
- Moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoisturizerOther
The test product is a novel moisturizer, that contains active ingredients, including rambutan extract, niacinamide, and glycoin.
| Study group | Role | What they receive |
|---|---|---|
| Novel moisturizer | Experimental | Subjects will apply the test product twice daily, both in the morning and the evening. Receives: Other: Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived changes in skin health
Survey based assessment of participants perceived skin health. Data was collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 6 representing the most beneficial response (i.e, "not noticeable" response to the question, "how would you rate the severity of your wrinkles") and 1 representing the least favorable/worse outcome ("severe").
Measured: Week 8
Changes in skin health via VISIA® imaging
VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and Week 8. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software. The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be Wrinkles, Spots, Pores, Texture, Redness and UV Damage. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes. Mean participant's scores for each parameter will be calculated at Baseline and Week 8 and compared for statistical significance.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start13 Oct 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin HealthStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thu Brulé
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861622
- Sponsor's protocol ID
- 20257
- Status last verified
- May 2023
- First submitted
- 3 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
- ClinicalTrials.gov ID
- NCT05861622
- Acronym / sponsor ID
- 20257
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Thu BruléIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 17 May 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.
Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture, skin is unlikely to have the properties most commonly associated with healthy skin. Recent research has recently highlighted that rambutan extract, niacinamide, and glycoin can all help promote skin moisture and health. To help people experience better skin health, Thu Brulé has developed a serum designed to be used twice daily. Specifically, the test product in this trial was designed to help moisturize the skin and help lock in that moisture. The purpose of this trial is to examine the efficacy of the test product across an eight-week hybrid trial. The outcomes of interest include participants' perceptions of skin health and photographs/images taken of the skin.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel moisturizer | Experimental | Other: MoisturizerSubjects will apply the test product twice daily, both in the morning and the evening. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female between the ages of 30-80.
- Frequently experience dry skin.
- Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication or over-the-counter products (e.g., Adapalene/Differin)
- Must be in good health with no unstable, uncontrolled health conditions.
- Must follow a stable, consistent dietary regimen.
Key exclusion criteria (12 listed)
- Females who are pregnant or breastfeeding
- Currently participating in another research study.
- Currently using oral retinoids.
- Individuals with self-reported very oily skin.
- Individuals with cystic acne or otherwise very acne-prone skin.
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 |
|---|---|---|
| MoisturizerThe test product is a novel moisturizer, that contains active ingredients, including rambutan extract, niacinamide, and glycoin. | Other | Novel moisturizer |
Primary outcome
Perceived changes in skin health
Time frame: Week 8
Survey based assessment of participants perceived skin health. Data was collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 6 representing the most beneficial response (i.e, "not noticeable" response to the question, "how would you rate the severity of your wrinkles") and 1 representing the least favorable/worse outcome ("severe").
Changes in skin health via VISIA® imaging
Time frame: Baseline to Week 8
VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and Week 8. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software. The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be Wrinkles, Spots, Pores, Texture, Redness and UV Damage. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes. Mean participant's scores for each parameter will be calculated at Baseline and Week 8 and compared for statistical significance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturizer in people with Skin Health, run by Thu Brulé at 1 site in United States.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 17 May 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived changes in skin health (time frame: Week 8). The study lists 2 primary outcomes in all. 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 17 May 2023.