Wrinkle AppearanceNCT03530787
Cosmetic Effects of Topical Acetyl Zingerone
A study testing Acetyl Zingerone Topical Cream and Topical cream in people with Wrinkle Appearance and Skin Pigment, run by University of California, Davis at 1 site in United States.
Trial summary
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle Appearance, Skin Pigment, Erythema
- What is being tested?
- Acetyl Zingerone Topical Cream and Topical cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 12 Oct 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 30-60
- Healthy subjects
Who cannot join
- Those that have had topical antibiotics within the past 4 weeks
- Those that have had oral antibiotics within past 4 weeks
- Those who have used systemic isotretinoin in the last 6 months
- Those with a known allergy to members of the ginger family
- Current smokers OR 20 pack-year history of smoking OR Have smoked within the past 3 years
- Pregnant women
Show all 10Show fewer
- Prisoners
- Those who have had any change to their hormonal birth control regimen in the last 4 weeks.
- Those with visible signs in the area of application of or on active treatment for cystic acne, eczema, seborrheic dermatitis, papulopustular rosacea at investigator discretion
- Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries at investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
Read the detailed description
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aim to study Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
Both curcumin and Zingerone are from the Zingiberacea family of plants (also known as the ginger family). Both have been widely studied and noted to have antibacterial effects and promote skin health effects. Curcumin has been studied widely in recent years due to various microbial effects. AZ is a derivative that is similar to both Zingerone and curcumin and has been noted to have many different activities including anti-inflammatory, antimicrobial, and antioxidant functions. However, there are no studies looking at how it modulates the skin cosmetically or the superficial microbiome.
The aim of this study was to compare the cosmetic effects of AZ to a vehicle over an 8-week period.
- Conditions
- Wrinkle Appearance, Skin Pigment, Erythema, Side Effect, Microbiome, Lipidome
- Being tested
- Acetyl Zingerone Topical Cream, Topical cream
- Keywords
- Ginger, Curcumin, Zingerone
- Medical subject headings
- Pigmentation Disorders, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Zingerone Topical CreamOther
Also called Synoxyl AZ (Brand Name)
Topical cream with an active acetyl zingerone component.
Topical creamOther
Topical cream without an active acetyl zingerone component and just the carrier cream.
| Study group | Role | What they receive |
|---|---|---|
| Acetyl Zingerone Group | Active comparator | This group was given the topical with the active acetyl zingerone agent. Receives: Other: Acetyl Zingerone Topical Cream |
| Control Group | Placebo comparator | This group was given the topical without the active acetyl zingerone agent and just the carrier lotion. Receives: Other: Topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wrinkle appearance
Change in image based analysis of wrinkle severity from baseline
Measured: 8 weeks
Change in appearance of skin pigmentation
Change in appearance of image based skin pigmentation from baseline
Measured: 8 weeks
Secondary outcomes (6)
Change in skin redness (erythema)
Change in image based skin redness (erythema) and clinical assessment of redness from baseline
Measured: 4 weeks and 8 weeks
Change in appearance of skin pigmentation
Change in appearance of image based skin pigmentation from baseline
Measured: 4 weeks
Change in wrinkle appearance
Change in image based analysis of wrinkle severity from baseline
Measured: 4 weeks
Appearance of side effects such as scaling or irritation
Appearance of side effects such as scaling or irritation from baseline
Measured: 4 weeks and 8 weeks
Change in superficial microbiome diversity
Change in superficial microbiome diversity from baseline
Measured: 4 weeks and 8 weeks
Change in superficial lipidome diversity
Change in superficial lipidome diversity from basline
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start11 Dec 2017
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wrinkle AppearanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to two groups: AZ Group (n= 17) Control Group (n=17)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530787
- Sponsor's protocol ID
- 1161176
- Status last verified
- Jan 2019
- First submitted
- 8 May 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Semwal RB, Semwal DK, Combrinck S, Viljoen AM. Gingerols and shogaols: Important nutraceutical principles from ginger. Phytochemistry. 2015 Sep;117:554-568. doi: 10.1016/j.phytochem.2015.07.012. Epub 2015 Jul 27.
PubMed 26228533Vaughn AR, Haas KN, Burney W, Andersen E, Clark AK, Crawford R, Sivamani RK. Potential Role of Curcumin Against Biofilm-Producing Organisms on the Skin: A Review. Phytother Res. 2017 Dec;31(12):1807-1816. doi: 10.1002/ptr.5912. Epub 2017 Sep 7.
PubMed 28884496Vaughn AR, Branum A, Sivamani RK. Effects of Turmeric (Curcuma longa) on Skin Health: A Systematic Review of the Clinical Evidence. Phytother Res. 2016 Aug;30(8):1243-64. doi: 10.1002/ptr.5640. Epub 2016 May 23.
PubMed 27213821Ahmad B, Rehman MU, Amin I, Arif A, Rasool S, Bhat SA, Afzal I, Hussain I, Bilal S, Mir Mu. A Review on Pharmacological Properties of Zingerone (4-(4-Hydroxy-3-methoxyphenyl)-2-butanone). ScientificWorldJournal. 2015;2015:816364. doi: 10.1155/2015/816364. Epub 2015 May 27.
PubMed 26106644
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
- ClinicalTrials.gov ID
- NCT03530787
- Acronym / sponsor ID
- 1161176
- Conditions
- Wrinkle Appearance, Skin Pigment, Erythema, Side Effect, Microbiome, Lipidome
- Keywords
- Ginger, Curcumin, Zingerone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 21 May 2018 (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.
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
Detailed description
Cosmeceuticals are an emerging market within dermatology and the growth of natural products and derivatives of natural products has accelerated in use within the field. Here the investigators aim to study Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
Both curcumin and Zingerone are from the Zingiberacea family of plants (also known as the ginger family). Both have been widely studied and noted to have antibacterial effects and promote skin health effects. Curcumin has been studied widely in recent years due to various microbial effects. AZ is a derivative that is similar to both Zingerone and curcumin and has been noted to have many different activities including anti-inflammatory, antimicrobial, and antioxidant functions. However, there are no studies looking at how it modulates the skin cosmetically or the superficial microbiome.
The aim of this study was to compare the cosmetic effects of AZ to a vehicle over an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to two groups: AZ Group (n= 17) Control Group (n=17)
| Arm | Type | Receives |
|---|---|---|
| Acetyl Zingerone Group | Active comparator | Other: Acetyl Zingerone Topical CreamThis group was given the topical with the active acetyl zingerone agent. |
| Control Group | Placebo comparator | Other: Topical creamThis group was given the topical without the active acetyl zingerone agent and just the carrier lotion. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals aged 30-60
- Healthy subjects
Key exclusion criteria (10 listed)
- Those that have had topical antibiotics within the past 4 weeks
- Those that have had oral antibiotics within past 4 weeks
- Those who have used systemic isotretinoin in the last 6 months
- Those with a known allergy to members of the ginger family
- Current smokers OR 20 pack-year history of smoking OR Have smoked within the past 3 years
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 |
|---|---|---|
| Acetyl Zingerone Topical CreamAlso: Synoxyl AZ (Brand Name)Topical cream with an active acetyl zingerone component. | Other | Acetyl Zingerone Group |
| Topical creamTopical cream without an active acetyl zingerone component and just the carrier cream. | Other | Control Group |
Primary outcome
Change in wrinkle appearance
Time frame: 8 weeks
Change in image based analysis of wrinkle severity from baseline
Change in appearance of skin pigmentation
Time frame: 8 weeks
Change in appearance of image based skin pigmentation from baseline
6 secondary outcomes
Change in skin redness (erythema)
Time frame: 4 weeks and 8 weeks
Change in appearance of skin pigmentation
Time frame: 4 weeks
Change in wrinkle appearance
Time frame: 4 weeks
Appearance of side effects such as scaling or irritation
Time frame: 4 weeks and 8 weeks
Change in superficial microbiome diversity
Time frame: 4 weeks and 8 weeks
Change in superficial lipidome diversity
Time frame: 4 weeks and 8 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 4 Jan 2019.
- Background: PubMed 26228533Semwal RB, Semwal DK, Combrinck S, Viljoen AM. Gingerols and shogaols: Important nutraceutical principles from ginger. Phytochemistry. 2015 Sep;117:554-568. doi: 10.1016/j.phytochem.2015.07.012. Epub 2015 Jul 27.
- Background: PubMed 28884496Vaughn AR, Haas KN, Burney W, Andersen E, Clark AK, Crawford R, Sivamani RK. Potential Role of Curcumin Against Biofilm-Producing Organisms on the Skin: A Review. Phytother Res. 2017 Dec;31(12):1807-1816. doi: 10.1002/ptr.5912. Epub 2017 Sep 7.
- Background: PubMed 27213821Vaughn AR, Branum A, Sivamani RK. Effects of Turmeric (Curcuma longa) on Skin Health: A Systematic Review of the Clinical Evidence. Phytother Res. 2016 Aug;30(8):1243-64. doi: 10.1002/ptr.5640. Epub 2016 May 23.
- Background: PubMed 26106644Ahmad B, Rehman MU, Amin I, Arif A, Rasool S, Bhat SA, Afzal I, Hussain I, Bilal S, Mir Mu. A Review on Pharmacological Properties of Zingerone (4-(4-Hydroxy-3-methoxyphenyl)-2-butanone). ScientificWorldJournal. 2015;2015:816364. doi: 10.1155/2015/816364. Epub 2015 May 27.
- Individual participant dataSharing planned: No
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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.
Raja Sivamani, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl Zingerone Topical Cream and Topical cream in people with Wrinkle Appearance and Skin Pigment, 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 2 inclusion and 10 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 4 Jan 2019. 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. Some participants in this study may receive a placebo. 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 wrinkle appearance (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?
On the ClinicalTrials.gov record for NCT03530787, which also lists 4 linked publications.
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 4 Jan 2019.