Prospective Study of Topical Vitamin C (THDA) Versus Topical Vitamin C (THDA) With Acetyl Zingerone

Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Acetyl Zingerone With Teterahexyldecyl Ascorbate (THDA) Versus THDA Alone

The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkle; Skin Pigmentation
• Intervention / Treatment: Other: THDA + Acetyl Zingerone Topical Product; Other: THDA

Detailed Description

In this study, we examine the effects of adding acetyl zingerone to vitamin-C derived ester THDA on its effects on the signs of photoaging (redness, uneven skin tone, and the appearance of fine lines) and compare it to the effects of applying THDA alone.

Acetyl zingerone is derived from ginger and has anti-oxidant properties

In this study, participants will be randomized to either receiving a THDA + acetyl zingerone product or a THDA only product.

This means that you will have an equal chance of receiving either product. You and the research team will not know which product you have been randomized to received because the products will be labelled with a code. The research team will only know which product contained THDA + acetyl zingerone and which product contained only THDA at the end of the study.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women between the ages of 30 years old and 65 years old.

Exclusion Criteria:

• Individuals who are pregnant or breastfeeding.
• Prisoners.
• Adults unable to consent.
• Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
• Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
• Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
• Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THDA + Acetyl Zingerone; Product will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed.	Other: THDA + Acetyl Zingerone Topical Product; A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily
Active Comparator: THDA only; Product will be used twice daily- once in the morning and once in the evening for 8 weeks. Each application will consist of 1-2 pumps (size of quarter) onto the face and neck, until fully absorbed.	Other: THDA; A skin care product with THDA (VitaSynol® C) used twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial fine lines and wrinkles	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Facial skin pigment evenness	Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial fine lines and wrinkles	Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Skin redness	Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Skin redness	Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)	8 weeks
Facial skin pigment evenness	Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)	4 weeks
Tolerability of product	Questionnaire based self-assessment about the tolerability of the topical skin product	4 weeks
Tolerability of product	Questionnaire based self-assessment about the tolerability of the topical skin product	8 weeks
Change in skin pigmentation in the undereye area	hange in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment	4 weeks
Change in skin pigmentation in the undereye area	hange in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment	8 weeks
Self-perception of skin parameters	Survey based self-assessment of facial features such as fine lines and wrinkles, skin smoothness, skin firmness	4 weeks
Self-perception of skin parameters	Survey based self-assessment of facial features such as fine lines and wrinkles, skin smoothness, skin firmness	8 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Sytheon Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin C; Acetyl Zingerone
• Other Study ID Numbers: TOP_AZ_THDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No