An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Serum on Skin Health and Signs of Aging

Skin Health Clinical Trial

Official title:

An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Serum on Skin Health and Signs of Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06148753
• Other study ID #: 20377
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: March 2024
• Source: Manuka Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Serum 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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, toner, and moisturizer for at least one month prior to starting the study.

• Must be willing to keep using the same cleanser, toner, and moisturizer 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, toner, and moisturizer 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.

Related Conditions & MeSH terms

• Skin Health

Intervention

Other:
• Manuka Health Eternal Renewal Regenerating Face Serum with Royal Jelly and Bee Venom
Face serum containing manuka honey, royal bee jelly, and bee venom.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Manuka Health	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks