Clinical trial NCT05778760: Prospective Study of Topical Adapinoid Versus Topical Retinol
Official title: Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Keywords: anti-aging
skin care
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Actera (Sponsor)
First posted: 2023-03-21
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.

Detailed description: We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate.

In this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.

Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 35 years old and 65 years old

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, acetyl zingerone, vitamin C, 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 of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid 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: Facial fine lines and wrinkles
timeFrame: 12 weeks
Secondary outcomes:
measure: Facial fine lines and wrinkles
timeFrame: 4 weeks
measure: Facial fine lines and wrinkles
timeFrame: 8 weeks
measure: Skin redness
timeFrame: 4 weeks
measure: Skin redness
timeFrame: 8 weeks
measure: Skin redness
timeFrame: 12 weeks
measure: Facial skin pigment evenness
timeFrame: 4 weeks
measure: Facial skin pigment evenness
timeFrame: 8 weeks
measure: Facial skin pigment evenness
timeFrame: 12 weeks
measure: Self-perception of skin health and appearance
timeFrame: 4 weeks
measure: Self-perception of skin health and appearance
timeFrame: 8 weeks
measure: Self-perception of skin health and appearance
timeFrame: 12 weeks
measure: Tolerability of product
timeFrame: 4 weeks
measure: Tolerability of product
timeFrame: 8 weeks
measure: Tolerability of product
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References: