AcneNCT05873933
An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes
A study testing Hemptress Oil in people with Acne and Eczema, run by Hemptress at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Eczema, Skin Aging
- What is being tested?
- Hemptress Oil
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Hemptress Oil
- Medical subject headings
- Acne Vulgaris, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemptress OilOther
Also called Hemptress Multifunction Oil
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**
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hemptress Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Why it stopped: Sponsor decided to run a different type of research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either one of two groups and their outcomes will be compared separately.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemptress
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873933
- Sponsor's protocol ID
- 20262
- Status last verified
- Oct 2024
- First submitted
- 16 May 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of a Multi-Function Skincare Product to Improve Aging, Eczema, and Acne Outcomes
- ClinicalTrials.gov ID
- NCT05873933
- Acronym / sponsor ID
- 20262
- Conditions
- Acne, Eczema, Skin Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to run a different type of research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HemptressIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to either one of two groups and their outcomes will be compared separately.
| Arm | Type | Receives |
|---|---|---|
| Acne and Eczema group | Experimental | Other: Hemptress OilParticipants 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 | Other: Hemptress OilParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemptress OilAlso: Hemptress Multifunction OilFull 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** | Other | Acne and Eczema group, Anti-Aging group |
Primary outcome
Changes in Skin Health [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
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).
1 secondary outcome
Change in VISIA® Skin Analysis Score [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemptress Oil in people with Acne and Eczema, run by Hemptress at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Skin Health [Time Frame: Baseline to Week 12] (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.