RhytidesNCT05041465
The Cosmetic Effect of Mineral Clay Masks
A study testing Clay mask in people with Rhytides, run by University of California, Davis at 1 site in United States.
Trial summary
The aim of this study is to evaluate the cosmetic effects of commercially available mineral clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhytides
- What is being tested?
- Clay mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Mar 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18-50
- Individuals in good general health
- Individuals free of any autoimmune or systemic disorder, which would interfere with the analysis.
Who cannot join
- Individuals who have been on any topical prescribed medications for the past 2 weeks
- Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
- Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the forehead, nose and the cheeks
- Female volunteers who are pregnant or planning to become pregnant over the course of the study. The risk to pregnant women is minimal but the facial appearance can be confounded by the altered hormones associated with pregnancy, as is well documented in chloasma which is dyspigmentation that arises in pregnancy. Women who become pregnant during the duration of the study will become ineligible but there are no birth control requirements.
- Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
- Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
Show all 9Show fewer
- Individuals who are currently using or during the past 14 days have used a retinoid such as tretinoin, adapalene, or retinol containing agents or a hydroquinone containing agent
- Individuals who have used mineral clay masks on their face within the last 14 days
- Individuals with a known history of hypersensitivity to any ingredients to the agent that is being assessed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95816
About this study
The aim of this study is to evaluate the cosmetic effects of commercially available mineral clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture will be assessed.
A second aim of the study is to assess the safety and tolerability of mineral clay masks by assessing redness and participant feedback.
- Conditions
- Rhytides
- Being tested
- Clay mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clay maskOther
Clay mask powders- French green, Rhassul and bentonite
| Study group | Role | What they receive |
|---|---|---|
| French Green Clay Mask | Experimental | Not described Receives: Other: Clay mask |
| Rhassoul Clay Mask | Experimental | Not described Receives: Other: Clay mask |
| Bentonite Clay Mask | Experimental | Not described Receives: Other: Clay mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks
Computer and photography based facial image analysis
Measured: 4 weeks
Secondary outcomes (1)
% of Participants with Skin redness intensity improvement at 4 weeks
Computer and photography based facial image analysis
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jan 2019
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041465
- Sponsor's protocol ID
- 1296789
- Status last verified
- Sep 2021
- First submitted
- 5 Mar 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cosmetic Effect of Mineral Clay Masks
- ClinicalTrials.gov ID
- NCT05041465
- Acronym / sponsor ID
- 1296789
- Conditions
- Rhytides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 13 Sep 2021 (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.
The aim of this study is to evaluate the cosmetic effects of commercially available mineral clay masks over a 4-week period. Changes in skin pigmentation, shine, wrinkles, and texture will be assessed.
A second aim of the study is to assess the safety and tolerability of mineral clay masks by assessing redness and participant feedback.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| French Green Clay Mask | Experimental | Other: Clay mask |
| Rhassoul Clay Mask | Experimental | Other: Clay mask |
| Bentonite Clay Mask | Experimental | Other: Clay mask |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals aged 18-50
- Individuals in good general health
- Individuals free of any autoimmune or systemic disorder, which would interfere with the analysis.
Key exclusion criteria (9 listed)
- Individuals who have been on any topical prescribed medications for the past 2 weeks
- Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
- Individuals with active (flaring) disease or chronic skin allergies (atopic dermatitis/eczema) or those who have recently undergone treatment for skin cancer (within the last 12 months) in the area of testing on the forehead, nose and the cheeks
- Female volunteers who are pregnant or planning to become pregnant over the course of the study. The risk to pregnant women is minimal but the facial appearance can be confounded by the altered hormones associated with pregnancy, as is well documented in chloasma which is dyspigmentation that arises in pregnancy. Women who become pregnant during the duration of the study will become ineligible but there are no birth control requirements.
- Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days
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 |
|---|---|---|
| Clay maskClay mask powders- French green, Rhassul and bentonite | Other | Bentonite Clay Mask, French Green Clay Mask, Rhassoul Clay Mask |
Primary outcome
Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks
Time frame: 4 weeks
Computer and photography based facial image analysis
1 secondary outcome
% of Participants with Skin redness intensity improvement at 4 weeks
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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 Clay mask in people with Rhytides, run by University of California, Davis 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Count of Participants with Decrease in Skin pigmentation intensity at 4 Weeks (time frame: 4 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 13 Sep 2021.