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

Study Overview
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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.

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

Conditions
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Wrinkle, Skin Pigmentation

Intervention / Treatment
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* Other: THDA + Acetyl Zingerone Topical Product
* Other: THDA


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THDA + Acetyl Zingerone<br>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<br>* A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily<br>|
| Active Comparator: THDA only<br>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<br>* A skin care product with THDA (VitaSynol® C) used twice daily<br>|

What is the study measuring?
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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 | 
| Facial skin pigment evenness | Change in the appearance of facial skin pigment intensity 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, Acetyl Zingerone