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

NCT05873933 | Withdrawn

• 1 other identifier: 20262
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne; Eczema; Skin Aging

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Secondary Outcomes (1)

• Change in VISIA® Skin Analysis Score [Time Frame: Baseline to Week 12]

  12 weeks

Study Arms (2)

Acne and Eczema group

EXPERIMENTAL

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.

Other: Hemptress Oil

Anti-Aging group

EXPERIMENTAL

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.

Other: Hemptress Oil

Interventions

Hemptress Oil OTHER

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\*\*

Also known as: Hemptress Multifunction Oil

Acne and Eczema group; Anti-Aging group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hemptress: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 09404, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Eczema

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Dermatitis; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either one of two groups and their outcomes will be compared separately.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

US (1)