Cosmetic Effects of Topical Acetyl Zingerone

Not Applicable

Completed

• Conditions: Microbiome; Skin Pigment; Erythema; Side Effect; Lipidome; Wrinkle Appearance
• Interventions: Other: Acetyl Zingerone Topical Cream; Other: Topical cream

• Registration Number: NCT03530787
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study Start: 2017-12-11
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2018-10-12
• Study Completion: 2018-10-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetyl Zingerone Group	Acetyl Zingerone Topical Cream	This group was given the topical with the active acetyl zingerone agent.
Control Group	Topical cream	This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.

Primary Outcome Measures

Name	Time	Method
Change in appearance of skin pigmentation	8 weeks	Change in appearance of image based skin pigmentation from baseline
Change in wrinkle appearance	8 weeks	Change in image based analysis of wrinkle severity from baseline

Secondary Outcome Measures

Name	Time	Method
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
Change in skin redness (erythema)	4 weeks and 8 weeks	Change in image based skin redness (erythema) and clinical assessment of redness from baseline
Change in wrinkle appearance	4 weeks	Change in image based analysis of wrinkle severity from baseline
Change in superficial lipidome diversity	4 weeks and 8 weeks	Change in superficial lipidome diversity from basline
Change in appearance of skin pigmentation	4 weeks	Change in appearance of image based skin pigmentation from baseline
Change in superficial microbiome diversity	4 weeks and 8 weeks	Change in superficial microbiome diversity from baseline

Trial Locations

Locations (1)

University of California-Davis, Department of Dermatology; 🇺🇸 Sacramento, California, United States