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An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes

Primary Purpose

Acne, Eczema, Skin Aging

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemptress Oil
Sponsored by
Hemptress
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acne

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: To be eligible to participate in the Acne and Eczema group in this study, an individual must meet all of the following criteria: Male or Female between 21-55 years of age. Must be in good general health. Must experience regular acne, pimples, eczema, or blemishes. Must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. We prefer less daily cleansing vs. more. If males go in the shower and rinse, that is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) - Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions. Must not be using retinoids. Must be willing to comply with the protocol. To be eligible to participate in the Anti-Aging group in this study, an individual must meet all of the following criteria: Male or Female between 40-65 years of age Must be in good general health. Must experience early-stage wrinkles not treated by topical or oral prescription drugs/medication or over-the-counter products May experience hyperpigmentation and dark spots. Must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing their face in the morning or the evening is sufficient. We prefer less daily cleansing vs. more. If males just go in the shower and rinse, that is fine. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection. (3) - Must NOT use any moisturizer besides our oil. Must be willing to use the test product in the morning and the evening. Must not be using retinoids. Must be willing to comply with the protocol. Is willing to come to the Citruslabs office for pictures of their skin to be taken at baseline and at the end of the study. Exclusion Criteria: An individual who meets the following criteria will be excluded from participation in this study in the Acne and Eczema Group: Females who are pregnant or breastfeeding Unwilling to follow the protocol. Unwilling to discontinue using all moisturizers except for the test product during the trial. Currently participating in another study. Usage of an oral acne treatment 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 learning or cognitive difficulties that would prevent them from reading and understanding questionnaires and surveys. Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes. Anyone who uses sunscreen that is mineral-based can participate if the brand is pre-approved. An individual who meets the following criteria will be excluded from participation in this study in the Anti-Aging Group: Females who are pregnant or breastfeeding Unwilling to follow the protocol. Unwilling to discontinue using all moisturizers except for the test product during the trial. Currently participating in another study. Usage of products that include chemical exfoliating ingredients such as glycolic acid, lactic acid, or salicylic acid. Use of oral or topical retinoids Individuals with cystic acne or otherwise very acne-prone skin. Individuals experiencing strong bouts of hormonal acne. 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 learning or cognitive difficulties that would prevent them from reading and understanding questionnaires and surveys. Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes. Anyone who uses sunscreen that is mineral-based can participate if the brand is pre-approved.

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acne and Eczema group

Anti-Aging group

Arm Description

Participants who experience regular acne, pimples, eczema, or blemishes. Must use the test products as prescribed. In addition, must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions.

Participants who experience early-stage wrinkles not treated by topical or oral prescription drugs/medication or over-the-counter products. Must use the test products as prescribed. In addition, must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions.

Outcomes

Primary Outcome Measures

Changes in Skin Health [Time Frame: Baseline to Week 12]
Survey-based assessment of participant-perceived changes in skin health. Assessed using 0-5 point Likert scale, with 0 representing the most beneficial outcome (no symptoms) and 5 representing the worst outcome (severe symptoms).

Secondary Outcome Measures

Change in VISIA® Skin Analysis Score [Time Frame: Baseline to Week 12]
VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and Week 8. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software. The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be Wrinkles, Spots, Pores, Texture, Redness and UV Damage. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes. Mean participant's scores for each parameter will be calculated at Baseline and Week 8 and compared for statistical significance.

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Hemptress
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05873933
Brief Title
An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes
Official Title
An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hemptress
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
For the skin to function optimally, it needs to be nourished and supplied with the necessary compounds to support health. However, many individuals are deficient in those compounds, leading to negative skin outcomes. Most products on the market today only supply one or two compounds that can benefit skin health. Hemptress has developed a multi-function oil designed to help with outcomes related to acne, aging, and eczema, among others. This twelve-week trial will examine the effectiveness of Hemptress' test product. This study will be a two-group trial with 45 participants per group. One group will focus on understanding the test product's effects on skin aging symptoms. The other group will focus on understanding the test product's effects on acne and eczema. The trial will be hybrid, and the participants will follow the use instructions provided by the research team.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Eczema, Skin Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either one of two groups and their outcomes will be compared separately.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acne and Eczema group
Arm Type
Experimental
Arm Description
Participants who experience regular acne, pimples, eczema, or blemishes. Must use the test products as prescribed. In addition, must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions.
Arm Title
Anti-Aging group
Arm Type
Experimental
Arm Description
Participants who experience early-stage wrinkles not treated by topical or oral prescription drugs/medication or over-the-counter products. Must use the test products as prescribed. In addition, must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions.
Intervention Type
Other
Intervention Name(s)
Hemptress Oil
Other Intervention Name(s)
Hemptress Multifunction Oil
Intervention Description
Full ingredient list of the test product: Rubus occidentalis (Black raspberry) seed oil*, Carica papaya (Papaya) seed oil*, Bixa orellana (Annatto) seed oil*, Orbignya oleifera (Babassu) seed oil*, Borago officinalis (Bourrache) seed oil*, Daucus carota (Carrot) seed oil*, Hibiscus sabdariffa (Hibiscus) seed oil*, Aronia melanocarpa (Chokeberry) seed oil*, Vaccinium macrocarpon (Cranberry) seed oil*, Moringa oleifera (Moringa) seed oil**, Persea americana (Avocado) oil*, Ribes nigrum (Black currant) seed oil*, Copaifera officinalis (Copaiba) resin*, Canabis sativa (Hemp) seed oil*, Moringa peregrina seed oil extract & Caprylic/Capric Triglyceride** (Moringa peregrina extract), Ascorbyl tetraisopalmitate (Vitamin C), Proprietary full-spectrum blend of Cannabis sativa (Hemp) extract, Silica (Algica), Ergocalciferol (Vitamin D2), Menaquinone (Vitamin K2), Tocopherol (Vitamin E)* Organic Ingredient* Wild Crafted/Regenerative**
Primary Outcome Measure Information:
Title
Changes in Skin Health [Time Frame: Baseline to Week 12]
Description
Survey-based assessment of participant-perceived changes in skin health. Assessed using 0-5 point Likert scale, with 0 representing the most beneficial outcome (no symptoms) and 5 representing the worst outcome (severe symptoms).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in VISIA® Skin Analysis Score [Time Frame: Baseline to Week 12]
Description
VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and Week 8. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software. The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be Wrinkles, Spots, Pores, Texture, Redness and UV Damage. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes. Mean participant's scores for each parameter will be calculated at Baseline and Week 8 and compared for statistical significance.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible to participate in the Acne and Eczema group in this study, an individual must meet all of the following criteria: Male or Female between 21-55 years of age. Must be in good general health. Must experience regular acne, pimples, eczema, or blemishes. Must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing of their face in the morning or the evening is sufficient. We prefer less daily cleansing vs. more. If males go in the shower and rinse, that is sufficient. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection (3) - Must NOT use any moisturizer besides our oil. Must use the test product in the morning and the evening daily. Must not be using retinoids and must not start using retinoids during the study. Must NOT use oral anti-acne medications/prescriptions. Must not be using retinoids. Must be willing to comply with the protocol. To be eligible to participate in the Anti-Aging group in this study, an individual must meet all of the following criteria: Male or Female between 40-65 years of age Must be in good general health. Must experience early-stage wrinkles not treated by topical or oral prescription drugs/medication or over-the-counter products May experience hyperpigmentation and dark spots. Must be willing to maintain the following skincare routine during the study: (1)Daily cleansing or rinsing their face in the morning or the evening is sufficient. We prefer less daily cleansing vs. more. If males just go in the shower and rinse, that is fine. (2) The option to wear sunscreen if the sunscreen brand is pre-approved - a person who does not wear sunscreen is more desirable. The test product does contain some sun protection. (3) - Must NOT use any moisturizer besides our oil. Must be willing to use the test product in the morning and the evening. Must not be using retinoids. Must be willing to comply with the protocol. Is willing to come to the Citruslabs office for pictures of their skin to be taken at baseline and at the end of the study. Exclusion Criteria: An individual who meets the following criteria will be excluded from participation in this study in the Acne and Eczema Group: Females who are pregnant or breastfeeding Unwilling to follow the protocol. Unwilling to discontinue using all moisturizers except for the test product during the trial. Currently participating in another study. Usage of an oral acne treatment 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 learning or cognitive difficulties that would prevent them from reading and understanding questionnaires and surveys. Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes. Anyone who uses sunscreen that is mineral-based can participate if the brand is pre-approved. An individual who meets the following criteria will be excluded from participation in this study in the Anti-Aging Group: Females who are pregnant or breastfeeding Unwilling to follow the protocol. Unwilling to discontinue using all moisturizers except for the test product during the trial. Currently participating in another study. Usage of products that include chemical exfoliating ingredients such as glycolic acid, lactic acid, or salicylic acid. Use of oral or topical retinoids Individuals with cystic acne or otherwise very acne-prone skin. Individuals experiencing strong bouts of hormonal acne. 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 learning or cognitive difficulties that would prevent them from reading and understanding questionnaires and surveys. Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes. Anyone who uses sunscreen that is mineral-based can participate if the brand is pre-approved.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
09404
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Renner
Phone
424-245-0285
Email
hello@citruslabs.com

12. IPD Sharing Statement

Learn more about this trial

An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes

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