Clinical trial NCT03530787: Cosmetic Effects of Topical Acetyl Zingerone
Official title: Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle Appearance
Skin Pigment
Erythema
Side Effect
Microbiome
Lipidome
Keywords: Ginger
Curcumin
Zingerone
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to two groups:

AZ Group (n= 17) Control Group (n=17)
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in wrinkle appearance
timeFrame: 8 weeks
measure: Change in appearance of skin pigmentation
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in skin redness (erythema)
timeFrame: 4 weeks and 8 weeks
measure: Change in appearance of skin pigmentation
timeFrame: 4 weeks
measure: Change in wrinkle appearance
timeFrame: 4 weeks
measure: Appearance of side effects such as scaling or irritation
timeFrame: 4 weeks and 8 weeks
measure: Change in superficial microbiome diversity
timeFrame: 4 weeks and 8 weeks
measure: Change in superficial lipidome diversity
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semwal RB, Semwal DK, Combrinck S, Viljoen AM. Gingerols and shogaols: Important nutraceutical principles from ginger. Phytochemistry. 2015 Sep;117:554-568. doi: 10.1016/j.phytochem.2015.07.012. Epub 2015 Jul 27.
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.
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.
citation: 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.