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

NCT ID: NCT05779280

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-06

Study Completion Date

2023-12-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wrinkle Skin Pigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

THDA + Acetyl Zingerone Topical Product

Intervention Type OTHER

A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily

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.

Group Type ACTIVE_COMPARATOR

THDA

Intervention Type OTHER

A skin care product with THDA (VitaSynol® C) used twice daily

Interventions

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THDA + Acetyl Zingerone Topical Product

A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily

Intervention Type OTHER

THDA

A skin care product with THDA (VitaSynol® C) used twice daily

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sytheon Ltd.

INDUSTRY

Sponsor Role collaborator

Integrative Skin Science and Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Integrative Skin Science and Research

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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TOP_AZ_THDA

Identifier Type: -

Identifier Source: org_study_id

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