Skin HealthNCT06148766
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
A study testing Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom in people with Skin Health, run by Manuka Health at 1 site in United States.
Trial summary
This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Health
- What is being tested?
- Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to 30 Apr 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 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female.
- 40-55 years of age.
- Must be in good general health.
- Must have concerns with overall skin health and appearance, including:
- Fine lines and wrinkles The appearance of dark spots
- Must be using the same cleanser and toner for at least one month prior to starting the study.
Show all 10Show fewer
- Must be willing to keep using the same cleanser and toner for the duration of the study.
- Must not be using oral or topical retinoids.
- In the last three months, has not introduced any new medications or supplements that target skin health.
- Must be willing to comply with the protocol.
Who cannot join
- Anyone with an allergy to bees or bee products.
- Females who are pregnant or breastfeeding.
- Unwilling to follow the protocol.
- Unwilling to maintain use of the same cleaner and toner for the duration of the study.
- Currently participating in another study.
- Use of oral or topical retinoids.
Show all 11Show fewer
- Individuals with cystic acne or otherwise self-reported very acne-prone skin.
- Use of a prescription medication relevant to the skin.
- Anyone undergoing cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
- Anyone sensitive or allergic to any ingredients found in the products.
- Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8.
Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.
- Conditions
- Skin Health
- Being tested
- Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee VenomOther
Face cream containing manuka honey, royal bee jelly, and bee venom.
| Study group | Role | What they receive |
|---|---|---|
| Eternal Renewal Regenerating Face Cream | Experimental | Participants will be required to apply the test product in the morning and before bedtime at night.
After thoroughly cleansing and toning the face, the participants will take a pea-sized amount of face cream and apply it to the face, massaging over the entire face with small circular movements until the cream has fully absorbed. Receives: Other: Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in signs of skin health over time assessed via Optic Elite Skin Analysis. [Timeframe: Baseline to Week 8]
The Optic Elite skin analysis system clinically measures the surface and subsurface layers of skin using digital imaging technology
Measured: 8 weeks
Secondary outcomes (8)
Changes in self-perceived appearance of fine lines and wrinkles. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin clarity. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin hydration. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin texture. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin hyperpigmentation. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin irritation. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin brightness. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Changes in self-perceived skin tone evenness. [Timeframe: Baseline to Week 8]
Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start9 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuka Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148766
- Sponsor's protocol ID
- 20378
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
- ClinicalTrials.gov ID
- NCT06148766
- Acronym / sponsor ID
- 20378
- Conditions
- Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Manuka HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Nov 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.
This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8.
Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eternal Renewal Regenerating Face Cream | Experimental | Other: Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee VenomParticipants will be required to apply the test product in the morning and before bedtime at night. After thoroughly cleansing and toning the face, the participants will take a pea-sized amount of face cream and apply it to the face, massaging over the entire face with small circular movements until the cream has fully absorbed. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female.
- 40-55 years of age.
- Must be in good general health.
- Must have concerns with overall skin health and appearance, including:
- Fine lines and wrinkles The appearance of dark spots
Key exclusion criteria (11 listed)
- Anyone with an allergy to bees or bee products.
- Females who are pregnant or breastfeeding.
- Unwilling to follow the protocol.
- Unwilling to maintain use of the same cleaner and toner for the duration of the study.
- Currently participating in another 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 |
|---|---|---|
| Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee VenomFace cream containing manuka honey, royal bee jelly, and bee venom. | Other | Eternal Renewal Regenerating Face Cream |
Primary outcome
Changes in signs of skin health over time assessed via Optic Elite Skin Analysis. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
The Optic Elite skin analysis system clinically measures the surface and subsurface layers of skin using digital imaging technology
8 secondary outcomes
Changes in self-perceived appearance of fine lines and wrinkles. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin clarity. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin hydration. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin texture. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin hyperpigmentation. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin irritation. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin brightness. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
Changes in self-perceived skin tone evenness. [Timeframe: Baseline to Week 8]
Time frame: 8 weeks
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Skin Health
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Enrolling by invitationPhase 2
Deployment and Evaluation of Humanoid Robotics in Coalition-Aligned Clinical Care Settings
Mobility Impairment, Clinical Workflow Optimization
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
RecruitingObservational study
A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials
Cancer
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 Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom in people with Skin Health, run by Manuka Health 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 10 inclusion and 11 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 20 Nov 2024. 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?
Changes in signs of skin health over time assessed via Optic Elite Skin Analysis. [Timeframe: Baseline to Week 8] (time frame: 8 weeks). 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 20 Nov 2024.