NCT05698485

Brief Summary

The purpose of this study is to analyze various cosmetic endpoints, subjective assessments, and skin parameters such as hydration, transepidermal water loss, fine lines, and wrinkles with the use of a 3-part skin care regimen.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

January 6, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

January 6, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Appearance of facial wrinkles

    Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)

    8 weeks

Secondary Outcomes (19)

  • Skin hydration

    1 week

  • Skin hydration

    4 weeks

  • Skin hydration

    8 weeks

  • Transepidermal water loss

    1 week

  • Transepidermal water loss

    4 weeks

  • +14 more secondary outcomes

Study Arms (1)

3 Step Skin Care Regimen

EXPERIMENTAL

3 different skin care products will be applied to the face

Other: Cleansing BalmOther: Facial SerumOther: Moisturizer

Interventions

DermResults Cleansing Balm w/ Avocado Oil twice daily

3 Step Skin Care Regimen

DermResults Advanced Serum w/ Hyaluronic Acid twice daily

3 Step Skin Care Regimen

DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily

3 Step Skin Care Regimen

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between the ages of 35 years old and 65 years old.
  • Must have facial fine lines and wrinkles.

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 1 months prior to joining the study.
  • Subjects using any topical retinoid, 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 cosmetic treatments in the past 6 months and who are unwilling to withhold facial cosmetic treatments during the study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, tightening 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 26, 2023

Study Start

February 1, 2023

Primary Completion

May 24, 2023

Study Completion

December 16, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations