The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes

July 24, 2023 updated by: Integrative Skin Science and Research
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 Step Skin Care Regimen
3 different skin care products will be applied to the face
Other: Cleansing Balm
DermResults Cleansing Balm w/ Avocado Oil twice daily
Other: Facial Serum
DermResults Advanced Serum w/ Hyaluronic Acid twice daily
Other: Moisturizer
DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Appearance of facial wrinkles
Time Frame: 8 weeks
Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin hydration
Time Frame: 1 week
Change in skin hydration by SkinMoistureMeterSC measurement
1 week
Skin hydration
Time Frame: 4 weeks
Change in skin hydration by SkinMoistureMeterSC measurement
4 weeks
Skin hydration
Time Frame: 8 weeks
Change in skin hydration by SkinMoistureMeterSC measurement
8 weeks
Skin texture/roughness
Time Frame: 1 week
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
1 week
Skin texture/roughness
Time Frame: 4 weeks
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
4 weeks
Skin texture/roughness
Time Frame: 8 weeks
Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System
8 weeks
Self-perception of skin parameters
Time Frame: 1 week
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
1 week
Self-perception of skin parameters
Time Frame: 4 weeks
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
4 weeks
Self-perception of skin parameters
Time Frame: 8 weeks
Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness
8 weeks
Tolerability of products
Time Frame: 1 week
Questionnaire based self-assessment about the tolerability of the topical skin products
1 week
Tolerability of products
Time Frame: 4 weeks
Questionnaire based self-assessment about the tolerability of the topical skin products
4 weeks
Tolerability of products
Time Frame: 8 weeks
Questionnaire based self-assessment about the tolerability of the topical skin products
8 weeks
Transepidermal water loss
Time Frame: 1 week
Change in transepidermal water loss measurement by Vapometer
1 week
Transepidermal water loss
Time Frame: 4 weeks
Change in transepidermal water loss measurement by Vapometer
4 weeks
Transepidermal water loss
Time Frame: 8 weeks
Change in transepidermal water loss measurement by Vapometer
8 weeks
Skin volume
Time Frame: 1 week
Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)
1 week
Skin volume
Time Frame: 4 weeks
Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)
4 weeks
Skin volume
Time Frame: 8 weeks
Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)
8 weeks
Appearance of facial wrinkles
Time Frame: 4 weeks
Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integrative Skin Science and Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Arbonne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARB_SKIN3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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