STUDY TITLE: Evaluation of the Sun Protection Factor (SPF) of Sunscreen Containing Formulas According to the FDA Final Rule

 PROTOCOL: FDA 

INTRODUCTION
Before agreeing to participate in this research study, it is important that you read and understand the following explanation of the study and procedures.  This statement describes the purpose, procedures, benefits, risks, discomforts and precautions of the study.  It also describes the alternative procedures that are available to you and your right to withdraw from the study at any time.  No guarantees or assurances can be made as to the results of the study.

The investigator is being paid by the sponsor (the company paying for this study) to conduct this research study.

You must be honest with the investigator about your health history or you may harm yourself by participating in this study.

BACKGROUND
You have been invited to participate in a research study designed to measure sunscreen protection against the ultraviolet radiation (UV) in sunlight.

You must be at least 18 and less than 70 years old, in good general health, and willing to follow study guidelines including medication restrictions and avoidance of sun and tanning lamp exposure both three months before and during the study.  Your skin photo-type and skin color tone must meet the study requirements.  You will be required to show identification before enrollment.  Due to equipment limitations, your weight can not exceed 300 lbs.  You cannot participate in this study if any of the following are true:

• You have visited a tanning parlor or used a tanning lamp or a tanning bed within the past three months
• You have had significant sun exposure in the last 2 months
• You have a history of phototoxic, photoallergic or abnormal responses to UV radiation (sunlight or tanning lamps).
• You have a sensitivity or allergy to cosmetic products, toiletries, sunscreens and/or topical drugs
• You have significant past or current medical history of systemic illness that may increase your risk of study participation or that may affect the results of the study, including but not limited to: history of cancer, lupus and uncontrolled diabetes, thyroid conditions, or hypertension
• You have any previous or present skin condition such severe acne (pimples), psoriasis, eczema, skin cancer, abnormal moles or any other condition that might increase the risk of your participation in this study.
• You have recently used any medicine that may make you more sensitive to sunlight, or allergy medicines, pain relief medicines or medicines for skin conditions. (This will be explained to you by the investigator or study technician and you will be shown a list of these medicines.)
• You have participated in SPF testing or any other clinical research study in the past 2 months.
• You have allergy or sensitivity to latex
• You are pregnant or planning on becoming pregnant while enrolled in the study or if you are currently nursing a child.

A list of prohibited medications will be provided to you.

NUMBER OF SUBJECTS
Up to 20 subjects may be required to complete these procedures for each test product.

DURATION OF STUDY AND PROCEDURES
The study will require three visits to the study site.  You must avoid exposure to the sun and tanning lamps for the duration of the study. You must also avoid taking the types of medicines listed above.  Also, during your study visits you will need to wear clothing that allows easy access to your mid-back between the beltline and shoulder blades (for example, a loose tee shirt).  Up to six test areas, approximately 2 inches by 5 inches in size, will be drawn on your back using a surgical marker.  Ink from this marker is meant to stay on the skin for several days and may stain your clothing or other fabrics that may come in contact with the marked areas.  During testing procedures your back, between the belt-line and shoulder blades must remain exposed.  Private changing areas will be available but testing procedures may be performed in the presence of site personnel and other test subjects.

Day 1

• You will be asked to read and sign this consent form and a brief medical history questionnaire to determine if you qualify for this study.
• You will be in a seated position for all procedures in this study.
• Your mid-back between the belt-line and shoulder blades will be examined for uneven skin tones or blemishes.
• The color of your skin will be measured at 3 locations on your back, using a colorimeter, which is a small hand-held device that lightly touches your skin.
• Your back will be examined using a small hand-held lamp called a woods lamp that does not touch your skin. The measurements will take a few seconds. If your skin photo-type or color tone measured as described do not meet the study requirements you will not be enrolled in the study. 
• If you qualify, a set of five UV doses of different amounts will be given on marked areas on your back that are about the size of a dime. This set of doses will take about 1 to 2 minutes.
• UV doses will be given using a solar simulator, which is about the size of a small television set, and contains a xenon arc lamp, filtered to produce light that resembles the ultraviolet portion of sunlight, but is about 30 times as intense.
• Time for Day 1 procedures will be approximately 30 minutes.

Day 2

• Between 16 and 24 hours after Day 1 procedures, you will return for an evaluation of your skin responses to the first set of UV doses.
• Mild sunburns are expected on some of the areas that received UV doses.
• You will be asked a few questions about any side effects that you may have experienced and asked to list any medications you are taking.
• Up to three test sunscreens and a standard sunscreen, with a known SPF, will be applied in the rectangles. The sunscreens will be applied to each test area of your skin by the technician, by spotting the material across the test area and gently spreading using a latex finger covering until a uniform film is applied to the entire area.  In some cases, the technician may use a bare finger if a test sunscreen requires this type of application.  The sunscreens will be allowed to dry for 15 minutes. 
• You will then be given a series of UV doses on each of the test areas. A typical series of UV doses will include 5 UV doses, about the size of a dime, given in each rectangle.  Times for these doses are typically 11 minutes to 25 minutes.  A series of UV doses will also be given on unprotected skin similar to those given during the Day 1 procedures. 
• The total time for this visit will be approximately 3 hours.

Day 3

• After 16-24 hours you will return for another evaluation of the sites on your back and you will again be asked a few questions about any side effects that you may have experienced and asked to list any medications you are taking.
• The total time for this visit will be approximately 15 minutes.

PHOTOGRAPHS
We may obtain photographs of treated sites on your back at some visits.  You will not be identifiable in any of the photographs and the photographs will be used only for scientific purposes, and possibly for research publications.  These photographs will be obtained using a digital camera and only the test area will be included.  You will be given the opportunity to view your photographs.

POSSIBLE SIDE EFFECTS AND RISKS
If you do not understand what any of these side effects mean, please ask the investigator or study staff to explain these terms to you. 

Because the study products are investigational, all of the side effects may not be known.  There may be rare and unknown side effects. Some of these may be life threatening.

You must tell the investigator or study staff about all side effects that you have. If you are not honest about your side effects, you may harm yourself by staying in this study.

A total of up to 30 UV exposures will be given to the test areas on your mid-back.  Five UV doses will be given on Day 1 on unprotected skin in one test area.  On Day 2, up to twenty UV doses will be given in sunscreen protected areas (five on each of the test product protected areas and five on the standard sunscreen protected area) and five UV doses will be given in an adjacent, unprotected area.

Possible side effects include:

• Sunburn
• Mild discomfort
• Itching
• Swelling
• Dryness
• Peeling
• Papules
• Ulceration or irritation around tested areas
• Heat spreading to other sites may also occur
• Tanning may occur at exposure sites and may persist for several months

Photographs of these conditions are available on request.

UNFORESEEN RISKS
The UV exposures used in this test are equivalent to approximately 1 day of summer sun exposure.  Long term exposures to sunlight and artificial ultraviolet (UV) radiation have been shown to cause premature aging of the skin, skin cancer and reactions to certain anti-inflammatory drugs and antibiotics.  Long term risks of the UV exposures used in this study are unknown.  There may be rare and unknown side effects. Some of these may be life threatening. 

Risks to the fetus (unborn child) are unknown.  If you are pregnant or planning on becoming pregnant you must not participate.  The study may involve currently unforeseeable risks to breastfed babies. If you are breastfeeding a child, you should not participate in the study.

IN CASE OF STUDY RELATED INJURY
In the unlikely event that medical treatment is required as a result of this study, it will be provided by the study sponsor at no cost to you.  No other compensation is offered in the event of a research-related injury.  You will not lose any of your legal rights as a research subject by signing this consent form.

ALTERNATIVE TO PARTICIPATING IN THE STUDY
This research study is for research purposes only.  The only alternative is not to participate in this study.

NEW FINDINGS
Any new important information which is discovered during the study and which may influence your willingness to continue participation in the study will be made available to you.

BENEFITS
You will receive no direct benefit from this study.  The knowledge gained from this study will contribute to the development of more effective sunscreens.

COMPENSATION FOR PARTICIPATION
You will receive a payment of $75.00 for completing the study.  If you do not complete the study, you will be paid the following for each visit you complete: Day 1: $10.00, Day 2: $45.00, Day 3: $20.00.  Payments are made by check upon completion of the study.

CONFIDENTIALITY
Your medical records are confidential except as required by law.  The study staff, the study sponsor or designee, IRB and other regulatory agencies including the Food and Drug Administration (FDA) may review records of your study participation.  However, confidentiality of any information you provide will be maintained to the maximum extent possible.

The data from this study may be submitted to a government website designed to provide information about clinical trials.  If submitted, a description of this clinical trial may be available on www.ClinicalTrials.gov, as required by U.S. Law.  This web site will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this website at any time.

The Institutional Review Board (IRB), and accrediting agencies may inspect and copy your records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If the study results are presented at meetings or printed in publications, your name will not be used.

You have the right to see your study records and you may withdraw your permission to collect and share your personal information pertaining to this study at any time.  Personal information collected before you withdrew your permission may continue to be shared as part of this study.  If you withdraw your permission allowing the collection and sharing of your personal information you will no longer be able to participate in this study.  You may withdraw your permission to collect and share personal information by sending a written request to:

CONTACT INFORMATION
If you have questions, concerns, or complaints about this study or to report a study related injury, contact the study investigator or study staff.

If you are unable to reach anyone above and you require immediate (life threatening) medical attention, please go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact the IRB.  IRB policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting.

If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office.

IRB has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IRB has approved your being in the study.  You must consider the information in this consent form for yourself and decide if you want to be in this study.

VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is entirely voluntary.  You may decide not to participate or you may withdraw from the study at any time without any effect on your future medical care.  Your refusal to participate or your withdrawal from the study will cause no penalty or loss of benefits to which you are entitled.  If you choose to withdraw from the study, you will be asked to state your reason for withdrawal and to have any procedures or examinations that the investigator feels are in your best interest.

Your participation in this study may be ended without your consent by the investigator, the sponsor, IRB, or the FDA at any time for the following reasons: if the study appears to be medically harmful to you, if you fail to follow directions for participating in the study, if we discover that you do not meet study requirements, if the study is stopped or for other administrative reasons.

AGREEMENT TO BE IN THE STUDY
This consent form contains important information to help you decide if you want to be in the study.  If you have any questions that are not answered in this consent form, ask one of the study staff.

Please answer YES or NO to the following questions:

1. Is this document in a language you understand?                        
2. Do you understand the information in this consent form?                     
3. Have you been given enough time to ask questions and talk about the study?
4. Have all of your questions been answered to your satisfaction?
5. Do you think you received enough information about the study?
6. Do you volunteer to be in this study of your own free will and without being pressured by the investigator or study staff? 
7. Do you know that you can leave the study at any time without giving a reason and without affecting your health care?
8. Do you know that your health records from this study may be reviewed by the sponsor company and by government authorities?        
9. Do you know that you cannot be in another study while you are in this study? 

IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, YOU SHOULD NOT SIGN THIS CONSENT FORM.

I HAVE CAREFULLY READ AND UNDERSTAND THIS INFORMED CONSENT

CONSENT
A signed and dated copy of this consent form will be given to me.  The test has been explained to my satisfaction and I agree to participate as described.  I have been given the opportunity to discuss all aspects of this study and to ask questions.  I am at least 18 years old, in good health, and freely give my informed consent to serve a subject in this study. 

I understand that the product I am testing is proprietary and highly confidential.  I agree that I will not disclose or describe this product to anyone who is not an employee of.  I also agree that if, as part of the testing procedure, I am required to take the product out of the building for use, I will not give it or show it to any friend, family member or acquaintance.  I will not use the product, or any information I received about the product, for any purpose other than my participation in the current testing process.

SIGNATURE: ________________________________________
DATE: __________

Name:______________________________________________

Address: ____________________________________________

City/State/Zip: _______________________________________

Home Telephone: _____________________________________

Cellular Telephone: ____________________________________

SIGNATURE OF PERSON CONDUCTING CONSENT DISCUSSION: _________________________________________________
DATE: ___________