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

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: Active, not recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Other: Cleansing Balm; Other: Facial Serum; Other: Moisturizer

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Appearance of facial wrinkles	Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin hydration	Change in skin hydration by SkinMoistureMeterSC measurement	1 week
Skin hydration	Change in skin hydration by SkinMoistureMeterSC measurement	4 weeks
Skin hydration	Change in skin hydration by SkinMoistureMeterSC measurement	8 weeks
Skin texture/roughness	Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System	1 week
Skin texture/roughness	Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System	4 weeks
Skin texture/roughness	Change in the appearance of photographic analysis of texture/roughness with BTBP 3D Camera System	8 weeks
Self-perception of skin parameters	Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness	1 week
Self-perception of skin parameters	Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness	4 weeks
Self-perception of skin parameters	Survey based self-assessment of facial fine lines and wrinkles, skin smoothness, skin firmness	8 weeks
Tolerability of products	Questionnaire based self-assessment about the tolerability of the topical skin products	1 week
Tolerability of products	Questionnaire based self-assessment about the tolerability of the topical skin products	4 weeks
Tolerability of products	Questionnaire based self-assessment about the tolerability of the topical skin products	8 weeks
Transepidermal water loss	Change in transepidermal water loss measurement by Vapometer	1 week
Transepidermal water loss	Change in transepidermal water loss measurement by Vapometer	4 weeks
Transepidermal water loss	Change in transepidermal water loss measurement by Vapometer	8 weeks
Skin volume	Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)	1 week
Skin volume	Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)	4 weeks
Skin volume	Change in skin volume/plumpness by photographic image analysis (BTBP 3D Camera System)	8 weeks
Appearance of facial wrinkles	Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)	4 weeks

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Arbonne

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 24, 2023
• Study Completion (Estimated): December 16, 2023

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID 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