A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines

Revision Skincare

Status: Completed

Conditions: Wrinkles; Fine Lines; Photoaging

Treatments: Combination Product: Sunscreen; Combination Product: Facial cleanser; Combination Product: Facial moisturizer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04545970

ASIRC-RS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Anti-aging Serum

Active Comparator group

Description:

Dosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks.

Treatment:

Combination Product: Facial cleanser

Combination Product: Sunscreen

Combination Product: Facial moisturizer

Placebo Serum

Placebo Comparator group

Description:

Dosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening. Study Duration: 12 weeks.

Treatment:

Combination Product: Facial cleanser

Combination Product: Sunscreen

Combination Product: Facial moisturizer