Cosmetic Effects of Topical Acetyl Zingerone

Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530787
• Other study ID #: 1161176
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: October 12, 2018

Study information

• Verified date: January 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Lipidome
• Microbiome
• Pigmentation Disorders
• Side Effect
• Skin Pigment
• Wrinkle Appearance

Intervention

Other:
• Acetyl Zingerone Topical Cream
Topical cream with an active acetyl zingerone component.
• Topical cream
Topical cream without an active acetyl zingerone component and just the carrier cream.

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ahmad B, Rehman MU, Amin I, Arif A, Rasool S, Bhat SA, Afzal I, Hussain I, Bilal S, Mir Mu. A Review on Pharmacological Properties of Zingerone (4-(4-Hydroxy-3-methoxyphenyl)-2-butanone). ScientificWorldJournal. 2015;2015:816364. doi: 10.1155/2015/816364. Epub 2015 May 27. Review. — View Citation

Semwal RB, Semwal DK, Combrinck S, Viljoen AM. Gingerols and shogaols: Important nutraceutical principles from ginger. Phytochemistry. 2015 Sep;117:554-68. doi: 10.1016/j.phytochem.2015.07.012. Epub 2015 Jul 27. Review. — View Citation

Vaughn AR, Branum A, Sivamani RK. Effects of Turmeric (Curcuma longa) on Skin Health: A Systematic Review of the Clinical Evidence. Phytother Res. 2016 Aug;30(8):1243-64. doi: 10.1002/ptr.5640. Epub 2016 May 23. Review. — View Citation

Vaughn AR, Haas KN, Burney W, Andersen E, Clark AK, Crawford R, Sivamani RK. Potential Role of Curcumin Against Biofilm-Producing Organisms on the Skin: A Review. Phytother Res. 2017 Dec;31(12):1807-1816. doi: 10.1002/ptr.5912. Epub 2017 Sep 7. Review. — View Citation

Outcome

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