Skin AgingNCT06125912
A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging
A study testing Dime Beauty TBT Cream in people with Skin Aging, run by Dime Beauty Co. at 1 site in United States.
Trial summary
This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Dime Beauty TBT Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 15 Feb 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females aged 18-65. Have one or more of the following: visible fine lines and wrinkles, dry skin, reduced skin elasticity, or generally unhealthy skin.
- Must be willing to use two different skincare products, one on each side of their face for the duration of the trial.
- Have a smartphone or camera to take before-and-after selfies.
Who cannot join
- Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
- Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
- Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
- Anyone who cannot/ will not commit to the study protocol. Anyone with a history of substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use both the test product and the positive control product (0.1% Retinol Clinical Trial Lotion). Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60. Photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.
- Conditions
- Skin Aging
- Being tested
- Dime Beauty TBT Cream, Positive Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dime Beauty TBT CreamOther
Test product contains: Water, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Dimethicone, Caprylic/Capric Tiglyceride, Cetearyl Alcohol, Dimethicone Crosspolymer, Glycerin, Glyceryl Stearate, Pentylene Glycol, 1,2-Hexanediol, Isododecane, Linoleic Acid, Caprylic/Capric/Succinic Triglyceride, Octadecene, Olea Europaea (Olive) Oil Unsaponifiables, Orobanche Rapum Extract, Phospholipids, Phytosterols, Polyglyceryl-6 Behenate, Polyglyceryl-6 Stearate, Propanediol, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric/Myristic/Stearic Triglyceride, Stearyl Dimethicone, Hydroxyacetophenone, Bakuchiol, Cetyl Ricinoleate, Tetrasodium Glutamate Diacetate, Tocopherol, Xanthan Gum.
Positive ControlOther
Also called 0.1% Retinol Clinical Trial Lotion
Water, Glycerin, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Pentylene Glycol, 1,2-Hexanediol, Cetearyl, Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydroxyacetophenone, Sodium Ascorbate, Tocopherol, Carbomer, Xanthan Gum, Retinol, PEG-40 Hydrogenated Castor Oil.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | All participants will use both the test product and the active control. Participants will use the creams in the evening, applying the TBT Cream to the right side of the face, and the positive control on the left side of the face. Receives: Other: Dime Beauty TBT Cream; Other: Positive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Measured: 60 days
Change in participants' perception of the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Change in skin elasticity. [Baseline to Day 60]
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Changes in signs of skin aging. [Baseline to Day 60]
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Measured: 60 days
Changes in participants' perception of signs of skin aging. [Baseline to Day 60]
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Changes in participants' perception of facial skin hydration. [Baseline to Day 60]
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Measured: 60 days
Changes in facial skin hydration. [Baseline to Day 60]
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Measured: 60 days
Secondary outcomes (2)
Comparison of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist. The left side of the face and the right side of the face will be compared.
Measured: 60 days
Comparison of participants perception of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe"). The left side of the face and the right side of the face will be compared.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start25 Sep 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dime Beauty Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125912
- Sponsor's protocol ID
- 20361
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging
- ClinicalTrials.gov ID
- NCT06125912
- Acronym / sponsor ID
- 20361
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dime Beauty Co.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 9 Nov 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.
This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use both the test product and the positive control product (0.1% Retinol Clinical Trial Lotion). Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60. Photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Other: Dime Beauty TBT Cream, Other: Positive ControlAll participants will use both the test product and the active control. Participants will use the creams in the evening, applying the TBT Cream to the right side of the face, and the positive control on the left side of the face. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females aged 18-65. Have one or more of the following: visible fine lines and wrinkles, dry skin, reduced skin elasticity, or generally unhealthy skin.
- Must be willing to use two different skincare products, one on each side of their face for the duration of the trial.
- Have a smartphone or camera to take before-and-after selfies.
Key exclusion criteria (4 listed)
- Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.
- Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.
- Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.
- Anyone who cannot/ will not commit to the study protocol. Anyone with a history of substance abuse.
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 |
|---|---|---|
| Dime Beauty TBT CreamTest product contains: Water, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Dimethicone, Caprylic/Capric Tiglyceride, Cetearyl Alcohol, Dimethicone Crosspolymer, Glycerin, Glyceryl Stearate, Pentylene Glycol, 1,2-Hexanediol, Isododecane, Linoleic Acid, Caprylic/Capric/Succinic Triglyceride, Octadecene, Olea Europaea (Olive) Oil Unsaponifiables, Orobanche Rapum Extract, Phospholipids, Phytosterols, Polyglyceryl-6 Behenate, Polyglyceryl-6 Stearate, Propanediol, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric/Myristic/Stearic Triglyceride, Stearyl Dimethicone, Hydroxyacetophenone, Bakuchiol, Cetyl Ricinoleate, Tetrasodium Glutamate Diacetate, Tocopherol, Xanthan Gum. | Other | Test Arm |
| Positive ControlAlso: 0.1% Retinol Clinical Trial LotionWater, Glycerin, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Pentylene Glycol, 1,2-Hexanediol, Cetearyl, Alcohol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Hydroxyacetophenone, Sodium Ascorbate, Tocopherol, Carbomer, Xanthan Gum, Retinol, PEG-40 Hydrogenated Castor Oil. | Other | Test Arm |
Primary outcome
Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
Time frame: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Change in participants' perception of the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
Time frame: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Change in skin elasticity. [Baseline to Day 60]
Time frame: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in signs of skin aging. [Baseline to Day 60]
Time frame: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
Changes in participants' perception of signs of skin aging. [Baseline to Day 60]
Time frame: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in participants' perception of facial skin hydration. [Baseline to Day 60]
Time frame: 60 days
Measured via participant-reported questionnaires. Questionnaires will be designed using a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in facial skin hydration. [Baseline to Day 60]
Time frame: 60 days
Photos of the participants' face before and after the intervention will be evaluated for a change in this parameter by a board-certified dermatologist.
2 secondary outcomes
Comparison of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
Time frame: 60 days
Comparison of participants perception of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
Time frame: 60 days
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 22 Feb 2024.
- 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 Dime Beauty TBT Cream in people with Skin Aging, run by Dime Beauty Co. 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 4 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 22 Feb 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 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?
Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60] (time frame: 60 days). The study lists 7 primary outcomes in all. 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 22 Feb 2024.