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Cosmetic Effects of Topical Acetyl Zingerone

Primary Purpose

Wrinkle Appearance, Skin Pigment, Erythema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetyl Zingerone Topical Cream
Topical cream
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrinkle Appearance focused on measuring Ginger, Curcumin, Zingerone

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California-Davis, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetyl Zingerone Group

Control Group

Arm Description

This group was given the topical with the active acetyl zingerone agent.

This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.

Outcomes

Primary Outcome Measures

Change in wrinkle appearance
Change in image based analysis of wrinkle severity from baseline
Change in appearance of skin pigmentation
Change in appearance of image based skin pigmentation from baseline

Secondary Outcome Measures

Change in skin redness (erythema)
Change in image based skin redness (erythema) and clinical assessment of redness from baseline
Change in appearance of skin pigmentation
Change in appearance of image based skin pigmentation from baseline
Change in wrinkle appearance
Change in image based analysis of wrinkle severity from baseline
Appearance of side effects such as scaling or irritation
Appearance of side effects such as scaling or irritation from baseline
Change in superficial microbiome diversity
Change in superficial microbiome diversity from baseline
Change in superficial lipidome diversity
Change in superficial lipidome diversity from basline

Full Information

First Posted
May 8, 2018
Last Updated
January 2, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03530787
Brief Title
Cosmetic Effects of Topical Acetyl Zingerone
Official Title
Randomized Double-Blind Study of the Cosmetic Effects of Topical Acetyl Zingerone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
October 12, 2018 (Actual)
Study Completion Date
October 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkle Appearance, Skin Pigment, Erythema, Side Effect, Microbiome, Lipidome
Keywords
Ginger, Curcumin, Zingerone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to two groups: AZ Group (n= 17) Control Group (n=17)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetyl Zingerone Group
Arm Type
Active Comparator
Arm Description
This group was given the topical with the active acetyl zingerone agent.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
This group was given the topical without the active acetyl zingerone agent and just the carrier lotion.
Intervention Type
Other
Intervention Name(s)
Acetyl Zingerone Topical Cream
Other Intervention Name(s)
Synoxyl AZ (Brand Name)
Intervention Description
Topical cream with an active acetyl zingerone component.
Intervention Type
Other
Intervention Name(s)
Topical cream
Intervention Description
Topical cream without an active acetyl zingerone component and just the carrier cream.
Primary Outcome Measure Information:
Title
Change in wrinkle appearance
Description
Change in image based analysis of wrinkle severity from baseline
Time Frame
8 weeks
Title
Change in appearance of skin pigmentation
Description
Change in appearance of image based skin pigmentation from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in skin redness (erythema)
Description
Change in image based skin redness (erythema) and clinical assessment of redness from baseline
Time Frame
4 weeks and 8 weeks
Title
Change in appearance of skin pigmentation
Description
Change in appearance of image based skin pigmentation from baseline
Time Frame
4 weeks
Title
Change in wrinkle appearance
Description
Change in image based analysis of wrinkle severity from baseline
Time Frame
4 weeks
Title
Appearance of side effects such as scaling or irritation
Description
Appearance of side effects such as scaling or irritation from baseline
Time Frame
4 weeks and 8 weeks
Title
Change in superficial microbiome diversity
Description
Change in superficial microbiome diversity from baseline
Time Frame
4 weeks and 8 weeks
Title
Change in superficial lipidome diversity
Description
Change in superficial lipidome diversity from basline
Time Frame
4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Davis, Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26228533
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.
Results Reference
background
PubMed Identifier
28884496
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.
Results Reference
background
PubMed Identifier
27213821
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.
Results Reference
background
PubMed Identifier
26106644
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.
Results Reference
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Cosmetic Effects of Topical Acetyl Zingerone

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