Clinical trial NCT04545970: A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fine Lines
Wrinkles
Photoaging
Keywords: anti-aging
serum
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: Ablon Skin Institute Research Center
First posted: 2020-09-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Detailed description: This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.

Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.

A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
* Women with Fitzpatrick Skin Type I-VI
* Subjects must have mild to moderate global face wrinkles and fine lines
* Subjects may have mild to moderate photo-aging secondary to physiologic aging
* Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria:

* Female subjects who are pregnant, breast feeding, or planning a pregnancy.
* Subjects with severe overall photo damage as determined by the Investigator.
* Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
* Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
* Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
* Subjects who spend excessive time out in the sun.
* Subjects who are unwilling or unable to comply with the requirements of the protocol.

Primary outcomes:
measure: Clinical Efficacy Graded by Griffiths' Scale
timeFrame: 12 weeks
measure: Objective Tolerability: scores
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjective Tolerability: scores
timeFrame: 12 weeks
measure: Self Assessment Questions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute Research Center
state: California
Study officials:
affiliation: Ablon Skin Institute Research Center
name: Glynis Ablon, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: