An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream
- Conditions
- PhotoagingWrinkleFine Lines
- Interventions
- Other: Gentle Cleansing Lotion, Revision SkincareOther: Aveeno Face Milk SPF 40+
- Registration Number
- NCT04911374
- Lead Sponsor
- Revision Skincare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anti-Aging Face Moisturizer and Eye Cream Gentle Cleansing Lotion, Revision Skincare Dual Regimen: 1. Multi-ingredient anti-aging face moisturizer 2. Multi-ingredient anti-aging eye cream Anti-Aging Face Moisturizer and Eye Cream Aveeno Face Milk SPF 40+ Dual Regimen: 1. Multi-ingredient anti-aging face moisturizer 2. Multi-ingredient anti-aging eye cream
- Primary Outcome Measures
Name Time Method Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline 12 weeks The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A change in scores at week 4, week 8 and week 12 in comparison to baseline indicates an improvement for the indicated parameter.
The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition): 0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate;7 to 9 = severe (worst possible condition). The lower the score equates to the best possible outcome.Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline 12 weeks The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome.
Example for Erythema: Erythema 0 = None No erythema of the treatment area
1. = Mild Slight, but definite redness of the treatment area
2. = Moderate Definite redness of the treatment area
3. = Severe Marked redness of the treatment area
- Secondary Outcome Measures
Name Time Method Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline 12 weeks • Tewameter Measurements at baseline and weeks 4, 8, and 12. A change in Tewameter values reflects an improvement in the barrier properties of the skin; an absence of a change in treated skin indicates mildness of the applied treatment.
Stable skin pH during 12 week study 12 weeks •pH Measurements at baseline and weeks 4, 8, and 12. A stable pH measurement reflects that the test product does not affect the overall cutaneous pH value.
Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline 12 weeks The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A change in scores or lack of significant change at week 4, week 8 and week 12 in comparison to Baseline indicates tolerability/safety of the test material. Four point scale with a lower score indicating a better outcome.
Example Burning. 0 = None No burning of the treatment area
1. = Mild Slight burning sensation of the treatment area; not really bothersome
2. = Moderate Definite warm, burning of the treatment area that is somewhat bothersome.
3. = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleepImprovement in Epidermal Thickness after 12 weeks versus baseline 12 weeks •OCT Imaging Procedures at baseline and week 12, with image analysis performed at the end of the study using images from baseline and week 12. A change in epidermal thickness indicates improvement.
Trial Locations
- Locations (1)
Stephens and Associates
🇺🇸Richardson, Texas, United States