Clinical trial NCT04911374: An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream
Official title: An Open-Label Clinical Study to Evaluate the Efficacy and Tolerability of a Multi-Ingredient Anti-aging Face Moisturizer and Eye Cream Targeting Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Photoaging
Fine Lines
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 45
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.
Primary purpose: TREATMENT

Brief summary: This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.

Detailed description: This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.

Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.

A total of 42 subjects completed the study.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 35 and 65 years
* Women with Fitzpatrick skin type I-VI
* Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
* 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:

* Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
* Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
* Subjects that are unwilling to comply with the protocol
* Female subjects who are pregnant, breast feeding, or planning a pregnancy.
* 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.

Primary outcomes:
measure: Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline
timeFrame: 12 weeks
measure: Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline
timeFrame: 12 weeks
measure: Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline
timeFrame: 12 weeks
measure: Stable skin pH during 12 week study
timeFrame: 12 weeks
measure: Improvement in Epidermal Thickness after 12 weeks versus baseline
timeFrame: 12 weeks
Other outcomes:
measure: Self-Assessment Questionnaire
timeFrame: 12 weeks
Locations:
city: Richardson
country: United States
facility: Stephens and Associates
state: Texas
Study officials:
References: