An Investigation of the Effects of a Skin Serum Containing Propolis on Skin Health and Appearance

This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Pro Vitality Daily Restorative Face Serum with Propolis & Vitamin C 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 Overview

• Status: Recruiting
• Conditions: Skin Health
• Intervention / Treatment: Other: Manuka Health Pro Vitality Daily Restorative Face Serum with Propolis & Vitamin C

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Citruslabs
      • Contact: Patrick Renner, MSc; Phone Number: 424-245-0284; Email: hello@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female between 30-42 years of age.
• Must be in good general health.
• Must have concerns with overall skin health and appearance, including:

Spots or blemishes Uneven skin tone Dull-looking skin

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pro Vitality Daily Restorative Face Serum; Participants will be required to apply the test product in the morning and before sleeping at night. After thoroughly cleansing and toning the face, the participants will apply 2-3 drops onto clean dry fingers and massage over the entire face until fully absorbed. The product should be followed with the participants' preferred moisturizer.	Other: Manuka Health Pro Vitality Daily Restorative Face Serum with Propolis & Vitamin C; Skin serum containing propolis, vitamin C, and manuka honey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Participants will receive a score that can be compared between time points.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Changes in self-perceived skin pigmentation. [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
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

Collaborators and Investigators

• Sponsor: Manuka Health
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Propolis
• Other Study ID Numbers: 20376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No