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

Not Applicable

Active, not recruiting

• Conditions: Wrinkle; Skin Pigmentation
• Interventions: Other: THDA + Acetyl Zingerone Topical Product; Other: THDA

• Registration Number: NCT05779280
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Study Start: 2023-04-06
• Status Verified: 2023-07
• Primary Completion: 2023-07-17
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
THDA + Acetyl Zingerone	THDA + Acetyl Zingerone Topical Product	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.
THDA only	THDA	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States