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

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05779280
• Other study ID #: TOP_AZ_THDA
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: July 2023
• Source: Integrative Skin Science and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 20, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Pigmentation
• Wrinkle

Intervention

Other:
• THDA + Acetyl Zingerone Topical Product
A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily
• THDA
A skin care product with THDA (VitaSynol® C) used twice daily

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Sytheon Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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