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

Integrative Skin Science and Research

Status: Active, not recruiting

Conditions: Skin Pigmentation; Wrinkle

Treatments: Other: THDA; Other: THDA + Acetyl Zingerone Topical Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT05779280

TOP_AZ_THDA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups

THDA + Acetyl Zingerone

Experimental group

Description:

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.

Treatment:

Other: THDA + Acetyl Zingerone Topical Product

THDA only

Active Comparator group

Description:

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.

Treatment:

Other: THDA