Wrinkle Clinical Trial
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
Verified date | September 2021 |
Source | Revision Skincare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | February 3, 2021 |
Est. primary completion date | December 22, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Stephens and Associates | Richardson | Texas |
Lead Sponsor | Collaborator |
---|---|
Revision Skincare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-Assessment Questionnaire | The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A change in response values at week 4, week 8 and week 12 indicates an improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement/ question being asked. | 12 weeks | |
Primary | Improvement of Clinical Efficacy Parameters at 4, 8, and 12 weeks versus Baseline | 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. |
12 weeks | |
Primary | Lack of Significant Increase in Objective Tolerability Parameters at week 4, 8, 12 compared to Baseline | 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 = Mild Slight, but definite redness of the treatment area = Moderate Definite redness of the treatment area = Severe Marked redness of the treatment area |
12 weeks | |
Secondary | Lack of Significant Increase in Subjective Tolerability Parameters at week 4, 8, 12 compared to Baseline | 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 = Mild Slight burning sensation of the treatment area; not really bothersome = Moderate Definite warm, burning of the treatment area that is somewhat bothersome. = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep |
12 weeks | |
Secondary | Decrease in transepidermal water loss at weeks 4, 8, and 12 versus baseline | • 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. | 12 weeks | |
Secondary | Stable skin pH during 12 week study | •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. | 12 weeks | |
Secondary | Improvement in Epidermal Thickness after 12 weeks versus baseline | •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. | 12 weeks |
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