WrinkleNCT05779280
Prospective Study of Topical Vitamin C (THDA) Versus Topical Vitamin C (THDA) With Acetyl Zingerone
A study testing THDA + Acetyl Zingerone Topical Product and THDA in people with Wrinkle and Skin Pigmentation, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Skin Pigmentation
- What is being tested?
- THDA + Acetyl Zingerone Topical Product and THDA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2023to 20 Dec 2023
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 30 years old and 65 years old.
Who cannot join
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
- Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research
Sacramento, California, 95815
About this study
Official title: Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Acetyl Zingerone With Teterahexyldecyl Ascorbate (THDA) Versus THDA Alone
The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone.
Read the detailed description
In this study, we examine the effects of adding acetyl zingerone to vitamin-C derived ester THDA on its effects on the signs of photoaging (redness, uneven skin tone, and the appearance of fine lines) and compare it to the effects of applying THDA alone.
Acetyl zingerone is derived from ginger and has anti-oxidant properties
In this study, participants will be randomized to either receiving a THDA + acetyl zingerone product or a THDA only product.
This means that you will have an equal chance of receiving either product. You and the research team will not know which product you have been randomized to received because the products will be labelled with a code. The research team will only know which product contained THDA + acetyl zingerone and which product contained only THDA at the end of the study.
- Conditions
- Wrinkle, Skin Pigmentation
- Being tested
- THDA + Acetyl Zingerone Topical Product, THDA
- Keywords
- Vitamin C, Acetyl Zingerone
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THDA + Acetyl Zingerone Topical ProductOther
A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily
THDAOther
A skin care product with THDA (VitaSynol® C) used twice daily
| Study group | Role | What they receive |
|---|---|---|
| THDA + Acetyl Zingerone | Experimental | Product will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed. Receives: Other: THDA + Acetyl Zingerone Topical Product |
| THDA only | Active comparator | Product will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed. Receives: Other: THDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial fine lines and wrinkles
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Facial skin pigment evenness
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Secondary outcomes (10)
Facial fine lines and wrinkles
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Facial skin pigment evenness
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Skin redness
Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)
Measured: 4 weeks
Skin redness
Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)
Measured: 8 weeks
Change in skin pigmentation in the undereye area
hange in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment
Measured: 4 weeks
Change in skin pigmentation in the undereye area
hange in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment
Measured: 8 weeks
Self-perception of skin parameters
Survey based self-assessment of facial features such as fine lines and wrinkles, skin smoothness, skin firmness
Measured: 4 weeks
Self-perception of skin parameters
Survey based self-assessment of facial features such as fine lines and wrinkles, skin smoothness, skin firmness
Measured: 8 weeks
Tolerability of product
Questionnaire based self-assessment about the tolerability of the topical skin product
Measured: 4 weeks
Tolerability of product
Questionnaire based self-assessment about the tolerability of the topical skin product
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start6 Apr 2023
- Primary completion17 Jul 2023
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779280
- Sponsor's protocol ID
- TOP_AZ_THDA
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Acetyl Zingerone With Teterahexyldecyl Ascorbate (THDA) Versus THDA Alone
- ClinicalTrials.gov ID
- NCT05779280
- Acronym / sponsor ID
- TOP_AZ_THDA
- Conditions
- Wrinkle, Skin Pigmentation
- Keywords
- Vitamin C, Acetyl Zingerone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Sytheon Ltd.
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 22 Mar 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.
The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone.
Detailed description
In this study, we examine the effects of adding acetyl zingerone to vitamin-C derived ester THDA on its effects on the signs of photoaging (redness, uneven skin tone, and the appearance of fine lines) and compare it to the effects of applying THDA alone.
Acetyl zingerone is derived from ginger and has anti-oxidant properties
In this study, participants will be randomized to either receiving a THDA + acetyl zingerone product or a THDA only product.
This means that you will have an equal chance of receiving either product. You and the research team will not know which product you have been randomized to received because the products will be labelled with a code. The research team will only know which product contained THDA + acetyl zingerone and which product contained only THDA at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THDA + Acetyl Zingerone | Experimental | Other: THDA + Acetyl Zingerone Topical ProductProduct will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed. |
| THDA only | Active comparator | Other: THDAProduct will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women between the ages of 30 years old and 65 years old.
Key exclusion criteria (7 listed)
- Individuals who are pregnant or breastfeeding.
- Prisoners.
- Adults unable to consent.
- Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
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 |
|---|---|---|
| THDA + Acetyl Zingerone Topical ProductA skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily | Other | THDA + Acetyl Zingerone |
| THDAA skin care product with THDA (VitaSynol® C) used twice daily | Other | THDA only |
Primary outcome
Facial fine lines and wrinkles
Time frame: 8 weeks
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Facial skin pigment evenness
Time frame: 8 weeks
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
10 secondary outcomes
Facial fine lines and wrinkles
Time frame: 4 weeks
Facial skin pigment evenness
Time frame: 4 weeks
Skin redness
Time frame: 4 weeks
Skin redness
Time frame: 8 weeks
Change in skin pigmentation in the undereye area
Time frame: 4 weeks
Change in skin pigmentation in the undereye area
Time frame: 8 weeks
Self-perception of skin parameters
Time frame: 4 weeks
Self-perception of skin parameters
Time frame: 8 weeks
Tolerability of product
Time frame: 4 weeks
Tolerability of product
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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 THDA + Acetyl Zingerone Topical Product and THDA in people with Wrinkle and Skin Pigmentation, run by Integrative Skin Science and Research 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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?
Results are not available in the source record.
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?
Facial fine lines and wrinkles (time frame: 8 weeks). The study lists 2 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 25 Jul 2023.