SPF Subject Questionnaire
- Are you currently pregnant or nursing? Yes*____ No ____
- Participants must be between 18 – 70 years old. Are you within this age range? Yes ____ No*____
- After a winter season of no sun exposure, how would your skin react to the first 30 to 45 minutes of sun exposure? Check one type only.
I |
Always burns easily; never tans (sensitive). |
|
II |
Always burns easily; tans minimally (sensitive). |
|
III |
Burns moderately; tans gradually (light brown) (normal). |
|
IV* |
Burns minimally; always tans well (moderate brown) (normal). |
|
V* |
Rarely burns; tans profusely (dark brown) (insensitive). |
|
VI* |
Never burns; deeply pigmented (insensitive). |
- Have you used a sunlamp or tanning parlor within the last 3 months?
Yes*____ No ____
- Have you participated in a clinical study within the last month?
Yes*____ No ____
- Are you in good general health? Yes ____ No*____
If no, explain ___________________________________________________
- Are you taking medications regularly? Yes ____ No ____
If yes, list medications (Include Dosage and Indication) ____________________________________________________
____________________________________________________
- List all medications taken within the last week (Including Dosage and Indication):
____________________________________________________
____________________________________________________
- Are you using any compounds on (see Protocol-15) the Prohibited Photosensitizing Compound list? Read the subject the categories /compounds on the list. Yes*____ No ____
- Do you have an abnormal response to UV radiation? Yes*____ No ____
- Do you have a sensitivity to sunscreens? Yes*____ No ____
- Do you have a sensitivity to topical products? Yes*____ No ____
- Do you have a history of psoriasis, atopic dermatitis, skin cancer, dysplastic nevi or other skin pathology? Yes*____ No ____
- Do you have scars? Yes*____ No ____
- Do you have active dermal lesions? Yes*____ No ____
- Do you have uneven skin tone? Yes*____ No ____
- Do you have Nevi, Blemishes, or Moles? Yes*____ No ____
These will be acceptable if, in a physician’s judgment, they will neither compromise the study nor jeopardize the subject’s safety.
- Do you have a history of any other condition which might interfere with the test or increase the risk of participation? Yes*____ No ____
If yes, explain ___________________________________________________
- Do you have transportation? We are located in Eagan, MN. Yes*____ No ____
- What days and times would you be available?
Monday Tuesday Wednesday Thursday Friday …
- Due to equipment limitations, subjects whose weight exceeds 300 lbs. may not participate in SPF tests. Are you over 300 lbs.?
Yes*____ No ____
Study Exclusion*
Findings: Eligible _______ Not Eligible: _______
Record reason for subject disqualification if applicable:
__________________________________________________
Technician Date