A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum

Revision Skincare

Status: Completed

Conditions: Fine Lines; Photoaging; Wrinkle

Treatments: Other: Cleansing Lotion; Other: Facial Moisturizer; Other: Sunscreen; Other: Anti-aging Serum

Study type: Interventional

Funder types: Industry

Identifiers

NCT05271136

C20-D146

Details and patient eligibility

About

This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer. A total of 26 female subjects, aged 34-60, completed study participation.

Full description

This double-blind, randomized, controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer (Cell 2). Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a dull appearance on the global face.

Efficacy and tolerability were assessed through clinical grading at baseline, day 3, and day 7. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and overall photodamage on the global face were performed 15 minutes post product application. Self-assessment questionnaires, Glossymeter measurements, and VISIA photography were completed at baseline, day 3, and day 7.

A total of 26 subjects completed study participation, which included 12 subjects in Cell 1, and 14 subjects in Cell 2.

Enrollment: 26 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female, 30 to 60 years of age
• Fitzpatrick skin type I -IV
• Moderate overall photodamage of the skin
• Moderate lack of firmness (visual) of the skin
• Moderate dull appearance of the skin
• Subjects must be willing to withhold all facial treatments during the course of the study and have not undergone a treatment within the last 6 months
• Subject must be willing to provide verbal understanding and written informed consent

Exclusion criteria

• Diagnosed with known allergies to facial skincare products
• Nursing, pregnant, or planning to become during the duration of the study
• History of skin cancer within the past 5 years
• Having used oral isotretinoin within the last 12 months
• Having used prescription-strength skin-lightening products within the last 3 months
• Having used any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within the last 4 weeks
• Having a health condition and/or pre-existing or dermatologic disorder that, in the Investigator's opinion, may interfere with the outcome of the study
• Having observable sunburn, suntan, scars, excessive facial hair, or other dermal conditions on the face that, in the Investigator's opinion, may influence test results
• Having a history of immunosuppression/immune deficiency disorders, or currently using oral or systemic immunosuppressive medications and biologics, and/or undergoing radiation or chemotherapy
• Using or having regularly used systemic or topical corticosteroids within the past 4 weeks
• Having started a long-term medication within the last 2 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Cell 1: Anti-aging Serum

Active Comparator group

Description:

Dosage form: Anti-aging Serum Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum. Study Duration: 7 days

Treatment:

Other: Sunscreen

Other: Anti-aging Serum

Other: Sunscreen

Other: Cleansing Lotion

Cell 2: Anti-aging Serum and Facial Moisturizer

Active Comparator group

Description:

Dosage form: Anti-aging Serum and Facial Moisturizer Frequency of Dosage: two times daily. Subjects are asked to apply 2 pumps of the Anti-aging Serum, and then 2 pumps of the Facial Moisturizer to the global face. Study Duration: 7 days

Treatment:

Other: Facial Moisturizer

Other: Sunscreen

Other: Anti-aging Serum

Other: Sunscreen

Other: Cleansing Lotion