Clinical trial NCT05698485: The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes
Official title: The Effects of a 3-Part Skin Care Regimen on Facial Wrinkles and Biophysical Attributes
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: 2023-01-26
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Appearance of facial wrinkles
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: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
References: