Cosmetic Effects of Topical Acetyl Zingerone

NCT03530787 | Completed

• 1 other identifier: 1161176
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrinkle Appearance; Skin Pigment; Erythema; Side Effect; Microbiome; Lipidome

Keywords

Ginger; Curcumin; Zingerone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in skin redness (erythema)

  4 weeks and 8 weeks

• Change in appearance of skin pigmentation

  4 weeks

• Change in wrinkle appearance

  4 weeks

• Appearance of side effects such as scaling or irritation

  4 weeks and 8 weeks

• Change in superficial microbiome diversity

  4 weeks and 8 weeks

Study Arms (2)

Acetyl Zingerone Group

ACTIVE COMPARATOR

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

Other: Acetyl Zingerone Topical Cream

Control Group

PLACEBO COMPARATOR

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

Other: Topical cream

Interventions

Acetyl Zingerone Topical Cream OTHER

Topical cream with an active acetyl zingerone component.

Also known as: Synoxyl AZ (Brand Name)

Acetyl Zingerone Group

Topical cream OTHER

Topical cream without an active acetyl zingerone component and just the carrier cream.

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 30-60
• Healthy subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (4)

• 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.

  PMID: 26228533 BACKGROUND

• 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.

  PMID: 28884496 BACKGROUND

• 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.

  PMID: 27213821 BACKGROUND

• 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.

  PMID: 26106644 BACKGROUND

MeSH Terms

Conditions

Pigmentation Disorders; Erythema

Interventions

Floderm topical cream

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Raja Sivamani, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to two groups: AZ Group (n= 17) Control Group (n=17)

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: December 11, 2017
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)