Cosmetic Effects of Topical Acetyl Zingerone

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wrinkle Appearance, Skin Pigment, Erythema, Side Effect, Microbiome, Lipidome

Intervention / Treatment
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* Other: Acetyl Zingerone Topical Cream
* Other: Topical cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to two groups: AZ Group (n= 17) Control Group (n=17)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetyl Zingerone Group<br>This group was given the topical with the active acetyl zingerone agent. | Other: Acetyl Zingerone Topical Cream<br>* Topical cream with an active acetyl zingerone component.<br>* Other names: Synoxyl AZ (Brand Name);|
| Placebo Comparator: Control Group<br>This group was given the topical without the active acetyl zingerone agent and just the carrier lotion. | Other: Topical cream<br>* Topical cream without an active acetyl zingerone component and just the carrier cream.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in wrinkle appearance | Change in image based analysis of wrinkle severity from baseline | 8 weeks | 
| Change in appearance of skin pigmentation | Change in appearance of image based skin pigmentation from baseline | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in skin redness (erythema) | Change in image based skin redness (erythema) and clinical assessment of redness from baseline | 4 weeks and 8 weeks | 
| Change in appearance of skin pigmentation | Change in appearance of image based skin pigmentation from baseline | 4 weeks | 
| Change in wrinkle appearance | Change in image based analysis of wrinkle severity from baseline | 4 weeks | 
| 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 | 
| Change in superficial microbiome diversity | Change in superficial microbiome diversity from baseline | 4 weeks and 8 weeks | 
| Change in superficial lipidome diversity | Change in superficial lipidome diversity from basline | 4 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginger, Curcumin, Zingerone