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

Sponsor
Manuka Health (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06148766
Collaborator
Citruslabs (Industry)
40
1
1
2.7
14.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Manuka Health Eternal Renewal Regenerating Face Cream with Royal Jelly and Bee Venom
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Investigation of the Effects of a Royal Jelly and Bee Venom-Derived Skin Cream on Skin Health and Signs of Aging
Actual Study Start Date :
Nov 9, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eternal Renewal Regenerating Face Cream

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.

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

Outcome Measures

Primary Outcome Measures

  1. Changes in signs of skin health over time assessed via Optic Elite Skin Analysis. [Timeframe: Baseline to Week 8] [8 weeks]

    The Optic Elite skin analysis system clinically measures the surface and subsurface layers of skin using digital imaging technology

Secondary Outcome Measures

  1. Changes in self-perceived appearance of fine lines and wrinkles. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  2. Changes in self-perceived skin clarity. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  3. Changes in self-perceived skin hydration. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  4. Changes in self-perceived skin texture. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  5. Changes in self-perceived skin hyperpigmentation. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  6. Changes in self-perceived skin irritation. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

  7. Changes in self-perceived skin brightness. [Timeframe: Baseline to Week 8] [8 weeks]

    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. Changes in self-perceived skin tone evenness. [Timeframe: Baseline to Week 8] [8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Citruslabs Santa Monica California United States 90404

Sponsors and Collaborators

  • Manuka Health
  • Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Manuka Health
ClinicalTrials.gov Identifier:
NCT06148766
Other Study ID Numbers:
  • 20378
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2023