Clinical trial NCT05271136: A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
Official title: A Double-blind, Randomized, Controlled Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fine Lines
Wrinkle
Photoaging
Keywords: anti-aging
serum
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: Stephens & Associates, Inc.
First posted: 2022-03-08
Enrollment: 26
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled, single-center
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Grading of Efficacy Parameters
timeFrame: 7 days
measure: Tolerability Evaluations
timeFrame: 7 days
Secondary outcomes:
measure: Irritation Evaluation
timeFrame: 7 days
measure: Self-assessment Questionnaire
timeFrame: 7 days
measure: Bioinstrumentation Measurements
timeFrame: 7 days
measure: VISIA-CR Photography
timeFrame: 7 days
Other outcomes:
Locations:
city: Richardson
country: United States
facility: SGS Stephens, Inc.
state: Texas
Study officials:
affiliation: SGS Stephens, Inc
name: Tanja Emmerich, PhD
role: PRINCIPAL_INVESTIGATOR
References: