The Effects of a 5-Step Skin Regimen on Pigmentation and... | NCT05688527

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

NCT05688527

Sponsor

Integrative Skin Science and Research

Status

Unknown status

Last Update Posted

Jul 25, 2023Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Wrinkle

Interventions

Cleansing Balm
Toning Essence
Facial Serum
Moisturizer
Eye Cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2023Actual

Primary Completion Date

May 16, 2023Actual

Completion Date

Dec 16, 2023Estimated

First Submitted Date

Jan 5, 2023

First Submission Date that Met QC Criteria

Jan 15, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 25, 2023Actual

Name	Class
Arbonne	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
5 Step Skin Care Regimen	Experimental	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 Other: Toning Essence Other: Facial Serum Other: Moisturizer Other: Eye Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cleansing Balm	Other	DermResults Cleansing Balm w/ Avocado Oil twice daily	5 Step Skin Care Regimen

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Skin hydration	Change in skin hydration by SkinMoistureMeterSC measurement	1 week
Skin hydration	Change in skin hydration by SkinMoistureMeterSC measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Integrative Skin Science and Research		Sacramento	California	95815	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided