Clinical trial NCT05688527: The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties
Official title: The Effects of a 5-Step Skin Regimen on Pigmentation and Appearance Related Biophysical Properties
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wrinkle
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Arbonne
First posted: 2023-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Appearance of facial wrinkles
timeFrame: 8 weeks
measure: Change in skin pigmentation in the undereye area
timeFrame: 8 weeks
Secondary outcomes:
measure: Skin hydration
timeFrame: 1 week
measure: Skin hydration
timeFrame: 4 weeks
measure: Skin hydration
timeFrame: 8 weeks
measure: Transepidermal water loss
timeFrame: 1 week
measure: Transepidermal water loss
timeFrame: 4 weeks
measure: Transepidermal water loss
timeFrame: 8 weeks
measure: Skin volume
timeFrame: 1 week
measure: Skin volume
timeFrame: 4 weeks
measure: Skin volume
timeFrame: 8 weeks
measure: Skin texture/roughness
timeFrame: 1 week
measure: Skin texture/roughness
timeFrame: 4 weeks
measure: Skin texture/roughness
timeFrame: 8 weeks
measure: Self-perception of skin parameters
timeFrame: 1 week
measure: Self-perception of skin parameters
timeFrame: 4 weeks
measure: Self-perception of skin parameters
timeFrame: 8 weeks
measure: Tolerability of products
timeFrame: 1 week
measure: Tolerability of products
timeFrame: 4 weeks
measure: Tolerability of products
timeFrame: 8 weeks
measure: Appearance of facial wrinkles
timeFrame: Change in wrinkle severity measured by photographic analysis (BTBP 3D Camera System)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: