Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decided to run a different type of research
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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** |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
To be eligible to participate in the Anti-Aging group in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets the following criteria will be excluded from participation in this study in the Acne and Eczema Group:
An individual who meets the following criteria will be excluded from participation in this study in the Anti-Aging Group:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 09404 | United States |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Participants will be assigned to either one of two groups and their outcomes will be compared separately.
Not provided
Not provided
Not provided
Not provided
|
|
| 12 weeks |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |