Clinical trial NCT06148766: An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
Official title: An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Lead sponsor: Manuka Health
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Changes in signs of skin health over time assessed via Optic Elite Skin Analysis. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in self-perceived appearance of fine lines and wrinkles. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin clarity. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin hydration. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin texture. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin hyperpigmentation. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin irritation. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin brightness. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
measure: Changes in self-perceived skin tone evenness. [Timeframe: Baseline to Week 8]
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: