Cosmetic Effects of Topical Acetyl Zingerone

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT03530787
Collaborator
(none)
31
1
2
10
3.1

Study Details

Study Description

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
  • Other: Acetyl Zingerone Topical Cream
  • Other: Topical cream
N/A

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

Study Type:
Interventional
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)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 :
Dec 11, 2017
Actual Primary Completion Date :
Oct 12, 2018
Actual Study Completion Date :
Oct 12, 2018

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in wrinkle appearance [8 weeks]

      Change in image based analysis of wrinkle severity from baseline

    2. Change in appearance of skin pigmentation [8 weeks]

      Change in appearance of image based skin pigmentation from baseline

    Secondary Outcome Measures

    1. Change in skin redness (erythema) [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 [4 weeks]

      Change in appearance of image based skin pigmentation from baseline

    3. Change in wrinkle appearance [4 weeks]

      Change in image based analysis of wrinkle severity from baseline

    4. Appearance of side effects such as scaling or irritation [4 weeks and 8 weeks]

      Appearance of side effects such as scaling or irritation from baseline

    5. Change in superficial microbiome diversity [4 weeks and 8 weeks]

      Change in superficial microbiome diversity from baseline

    6. Change in superficial lipidome diversity [4 weeks and 8 weeks]

      Change in superficial lipidome diversity from basline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of California-Davis, Department of Dermatology Sacramento California United States 95816

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT03530787
    Other Study ID Numbers:
    • 1161176
    First Posted:
    May 21, 2018
    Last Update Posted:
    Jan 4, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2019