The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties

This study is to analyze the effects of a 5-step skin care regimen on various skin parameters such as pigmentation, and firmness and elasticity of the skin around the eyes. The 5 facial products in the regimen are a cleansing balm, a toner, a serum, a moisturizer. and an eye cream.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Other: Cleansing Balm; Other: Toning Essence; Other: Facial Serum; Other: Moisturizer; Other: Eye Cream

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

Contacts and Locations

• Study Contact: Name: Jessica Maloh, ND; Phone Number: 9167502463; Email: jessica@integrativeskinresearch.com
• Study Contact Backup: Name: Raja Sivamani, MD MS AP

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
      • Contact: Raja Sivamani, M.D.; Phone Number: 916-524-1216; Email: research@integrativeskinresearch.com
      • Principal Investigator: Raja Sivamani, M.D.
      • Sub-Investigator: Waqas Burney, M.D.

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 fine lines and wrinkles around the eyes.

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, hydroquinone, kojic acid, 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 facial 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: 5 Step Skin Care Regimen; The subject uses 5 facial products in the regimen; a cleansing balm, a toner, a serum, a moisturizer and an eye cream.

Other: Cleansing Balm; DermResults Cleansing Balm w/ Avocado Oil twice daily; Other: Toning Essence; DermResults Advanced Toning Essence w/ Mineral Booster twice daily; Other: Facial Serum; DermResults Advanced Serum w/ Hyaluronic Acid twice daily; Other: Moisturizer; DermResults Advanced Moisturizer w/ Hyaluronic Acid twice daily; Other: Eye Cream; DermResults Advanced Eye Cream 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
Change in skin pigmentation in the undereye area	Change in skin pigmentation in the undereye area by Skin colorimetric analysis of pigment	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
Transepidermal water loss	Change in transepidermal water loss measurement with Vapometer	1 week
Transepidermal water loss	Change in transepidermal water loss measurement with Vapometer	4 weeks
Transepidermal water loss	Change in transepidermal water loss measurement with Vapometer	8 weeks
Skin volume	Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System	1 week
Skin volume	Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System	4 weeks
Skin volume	Change in skin volume/plumpness by photographic image analysis with BTBP 3D Camera System	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
Appearance of facial wrinkles	4 weeks	Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): May 16, 2023
• Study Completion (Estimated): December 16, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 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_SKIN5

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