Clinical trial NCT05779280: Prospective Study of Topical Vitamin C (THDA) Versus Topical Vitamin C (THDA) With Acetyl Zingerone
Official title: Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Acetyl Zingerone With Teterahexyldecyl Ascorbate (THDA) Versus THDA Alone
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wrinkle
Skin Pigmentation
Keywords: Vitamin C
Acetyl Zingerone
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Sytheon Ltd.
First posted: 2023-03-22
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial fine lines and wrinkles
timeFrame: 8 weeks
measure: Facial skin pigment evenness
timeFrame: 8 weeks
Secondary outcomes:
measure: Facial fine lines and wrinkles
timeFrame: 4 weeks
measure: Facial skin pigment evenness
timeFrame: 4 weeks
measure: Skin redness
timeFrame: 4 weeks
measure: Skin redness
timeFrame: 8 weeks
measure: Change in skin pigmentation in the undereye area
timeFrame: 4 weeks
measure: Change in skin pigmentation in the undereye area
timeFrame: 8 weeks
measure: Self-perception of skin parameters
timeFrame: 4 weeks
measure: Self-perception of skin parameters
timeFrame: 8 weeks
measure: Tolerability of product
timeFrame: 4 weeks
measure: Tolerability of product
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: