I am being asked to volunteer for this study because I am a healthy female between the ages of 35 to 55 who possess moderate uneven skin tone, age spots, pores, lines & wrinkles, redness, sagginess, and dullness.
Only after carefully reading this consent form, signing it, and if I agree to participate, will the following happen:
First, a general screening to see if I am eligible:
To make sure I am in good physical health, and to make sure my skin type is suitable for this study my facial skin will be examined. This will be performed before the start of the study.
To be eligible for this study, I will have to:
- Be between 35 to 55 years of age.
- Be of Fitzpatrick …show more content…
Each visit session will last 90-120 minutes.
On the first study visit, I will report to the test site with clean skin free of any make-up, products, or lotion.
I will complete a sign in sheet, screener, consent document and be instructed by study staff.
Subsequently, I will acclimate in a temperature controlled area for approximately 20 minutes.
At the baseline visit, I will have my facial skin examined by the study staff.
After completion of the examination, I will have photography taken, before having instrumental measurements.
I will then apply the study product as directed and after approximately 10 minutes, photography and other measurements will be taken.
At Visit 2 (Overnight) and Visit 3, I will have my facial skin examined by study staff.
After the completion of the examination, I will have photography taken, before having instrumental measurements taken.
Risks/Discomforts
The study product has been extensively tested in the past, thus significant side effects are unlikely to occur. The most common side effects may include (but are not limited to): burning, itching, stinging, tingling, etc.
If you should develop an adverse effect, then you will be discontinued from the study and treated (if …show more content…
The Sponsor and other Agencies are entitled to review the data, but the subjects’ identities are not revealed (initials will be used). Anonymity will be maintained in any public reports or publications.
Consent Process and Documentation
The individual responsible for the conduct of this study is Dr. John Ademola. Before the commencement of this study, signed, written consent will be obtained from you by a delegated study staff member.
Benefits, Compensation, Questions
There are no direct benefits for participating in this study. The results of the study will enable the investigators to determine the performance of the test product. Compensation for full participation in this study (compliance with the study protocol, use of the product, visiting the study clinic at Baseline, Overnight, and Visit 3 and recording the time you use the product on a diary) will be $150. This study has been explained to me by Dr. Ademola or a by a study staff member. If I have further questions, I can call the study staff members at
415-239-8006 or Dr. Ademola 415-845-4638.
Consent
I have been given a copy of this consent form and photo release.
I have read the information about this study; I consent to participate in this