Cosmetic Effects of Topical Acetyl Zingerone

NCT ID: NCT03530787

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2018-10-12

Brief Summary

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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

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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

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Wrinkle Appearance Skin Pigment Erythema Side Effect Microbiome Lipidome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to two groups:

AZ Group (n= 17) Control Group (n=17)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind

Study Groups

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Acetyl Zingerone Group

This group was given the topical with the active acetyl zingerone agent.

Group Type ACTIVE_COMPARATOR

Acetyl Zingerone Topical Cream

Intervention Type OTHER

Topical cream with an active acetyl zingerone component.

Control Group

This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.

Group Type PLACEBO_COMPARATOR

Topical cream

Intervention Type OTHER

Topical cream without an active acetyl zingerone component and just the carrier cream.

Interventions

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Acetyl Zingerone Topical Cream

Topical cream with an active acetyl zingerone component.

Intervention Type OTHER

Topical cream

Topical cream without an active acetyl zingerone component and just the carrier cream.

Intervention Type OTHER

Other Intervention Names

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Synoxyl AZ (Brand Name)

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 30-60
* Healthy subjects

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raja Sivamani, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California-Davis, Department of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26228533 (View on PubMed)

Vaughn 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.

Reference Type BACKGROUND
PMID: 28884496 (View on PubMed)

Vaughn 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.

Reference Type BACKGROUND
PMID: 27213821 (View on PubMed)

Ahmad 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.

Reference Type BACKGROUND
PMID: 26106644 (View on PubMed)

Other Identifiers

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1161176

Identifier Type: -

Identifier Source: org_study_id

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