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Cosmetic Effects of Topical Acetyl Zingerone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530787
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief 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 compound designed based on Zingerone and curcumin.

Condition or disease Intervention/treatment Phase
Wrinkle Appearance Skin Pigment Erythema Side Effect Microbiome Lipidome Other: Acetyl Zingerone Topical Cream Other: Topical cream Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subjects will be randomized to two groups:

AZ Group (n= 17) Control Group (n=17)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
Actual Study Start Date : December 11, 2017
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in wrinkle appearance [ Time Frame: 8 weeks ]
    Change in image based analysis of wrinkle severity from baseline

  2. Change in appearance of skin pigmentation [ Time Frame: 8 weeks ]
    Change in appearance of image based skin pigmentation from baseline


Secondary Outcome Measures :
  1. 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

  2. Change in appearance of skin pigmentation [ Time Frame: 4 weeks ]
    Change in appearance of image based skin pigmentation from baseline

  3. Change in wrinkle appearance [ Time Frame: 4 weeks ]
    Change in image based analysis of wrinkle severity from baseline

  4. 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

  5. Change in superficial microbiome diversity [ Time Frame: 4 weeks and 8 weeks ]
    Change in superficial microbiome diversity from baseline

  6. Change in superficial lipidome diversity [ Time Frame: 4 weeks and 8 weeks ]
    Change in superficial lipidome diversity from basline


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530787


Locations
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United States, California
University of California-Davis, Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja Sivamani, MD University of California, Davis
More Information
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Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03530787    
Other Study ID Numbers: 1161176
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Ginger
Curcumin
Zingerone
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations