Clinical trial NCT05514782: A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
Official title: Double-Blinded, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Tolerability of a Daily Serum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photoaging
Wrinkle
Keywords: anti-aging
daily serum
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: KGL, Inc.
First posted: 2022-08-24
Enrollment: 67
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-blinded, placebo-controlled, single-center
Primary purpose: OTHER

Brief summary: This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum to improve moderate overall photodamage and skin fatigue after 12-weeks of twice-daily used when compared to a placebo-serum (vehicle control). A total of 62 subjects, 34-60 years of age completed study participation.

Detailed description: This double-blind, randomized, placebo-controlled, single-center clinical trial was conducted to assess the efficacy and tolerance of an anti-aging daily serum (Cell 1) to improve moderate overall photodamage and skin fatigue of aging skin after 12-weeks days of twice-daily use when compared to the efficacy of a combination of a placebo-control (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, week 4, week 8, and week 12. 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 at baseline and post-baseline by a clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at baseline and week 12 were performed by two board certified dermatologists.

Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects, a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies collected from the lateral, pre-auricular at baseline and week 12.

A total of 62 subjects completed study participation (31 in Cell 1 and 31 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: Change In Clinical Efficacy Parameter Radiance Versus Baseline
timeFrame: 12 weeks
measure: Change in Active Cell versus Placebo Control in Clinical Efficacy at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Lack of Significant Increase in Objective Investigator Tolerability Parameters at week 4, 8, 12 compared to Baseline
timeFrame: 12 weeks
measure: Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
timeFrame: 12 weeks
Other outcomes:
measure: Change In Facial parameters in a self-assessment questionnaire versus Baseline and % Agreement
timeFrame: 12 weeks
measure: Bioinstrumentation -Quantitative and Qualitative Data
timeFrame: 12 weeks
measure: Bioinstrumentation - Quantitative and Qualitative Data
timeFrame: 12 weeks
Locations:
city: West Chester
country: United States
facility: KGL Skin Study Center
state: Pennsylvania
Study officials:
References: