Cosmetic Effects of Topical Acetyl Zingerone

January 2, 2019 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of California-Davis, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetyl Zingerone Group
This group was given the topical with the active acetyl zingerone agent.
Other: Acetyl Zingerone Topical Cream
Topical cream with an active acetyl zingerone component.
Other Names:
  • Synoxyl AZ (Brand Name)
Placebo Comparator: Control Group
This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.
Other: Topical cream
Topical cream without an active acetyl zingerone component and just the carrier cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in wrinkle appearance
Time Frame: 8 weeks
Change in image based analysis of wrinkle severity from baseline
8 weeks
Change in appearance of skin pigmentation
Time Frame: 8 weeks
Change in appearance of image based skin pigmentation from baseline
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin redness (erythema)
Time Frame: 4 weeks and 8 weeks
Change in image based skin redness (erythema) and clinical assessment of redness from baseline
4 weeks and 8 weeks
Change in appearance of skin pigmentation
Time Frame: 4 weeks
Change in appearance of image based skin pigmentation from baseline
4 weeks
Change in wrinkle appearance
Time Frame: 4 weeks
Change in image based analysis of wrinkle severity from baseline
4 weeks
Appearance of side effects such as scaling or irritation
Time Frame: 4 weeks and 8 weeks
Appearance of side effects such as scaling or irritation from baseline
4 weeks and 8 weeks
Change in superficial microbiome diversity
Time Frame: 4 weeks and 8 weeks
Change in superficial microbiome diversity from baseline
4 weeks and 8 weeks
Change in superficial lipidome diversity
Time Frame: 4 weeks and 8 weeks
Change in superficial lipidome diversity from basline
4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Raja Sivamani, MD, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2017

Primary Completion (Actual)

October 12, 2018

Study Completion (Actual)

October 12, 2018

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1161176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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