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NCT Number: NCT03530787

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.

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Key information

Conditions

Wrinkle Appearance Erythema Lipidome Microbiome Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Side Effect Signs and Symptoms Skin Diseases Skin Manifestations Skin Pigment Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetyl Zingerone Topical Cream

Other

Topical cream with an active acetyl zingerone component.

Other names: Synoxyl AZ (Brand Name)

Topical cream

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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