NCT05779280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

April 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

March 9, 2023

Last Update Submit

July 24, 2023

Conditions

WrinkleSkin Pigmentation

Keywords

Vitamin CAcetyl Zingerone

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Facial fine lines and wrinkles

    4 weeks

  • Facial skin pigment evenness

    4 weeks

  • Skin redness

    4 weeks

  • Skin redness

    8 weeks

  • Change in skin pigmentation in the undereye area

    4 weeks

  • +5 more secondary outcomes

Study Arms (2)

THDA + Acetyl Zingerone

EXPERIMENTAL

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

THDA only

ACTIVE COMPARATOR

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

Interventions

THDA + Acetyl Zingerone Topical ProductOTHER

A skin care product with Acetyl Zingerone (Synoxyl® AZ) and THDA (VitaSynol® C) used twice daily

THDA + Acetyl Zingerone
THDAOTHER

A skin care product with THDA (VitaSynol® C) used twice daily

THDA only

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between the ages of 30 years old and 65 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

April 6, 2023

Primary Completion

July 17, 2023

Study Completion

December 20, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)