Evaluating the sunburn protection of umbrella shade compared to sunscreen at the beach
- Conditions
- SunburnSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN19177299
- Lead Sponsor
- Johnson & Johnson Consumer & Personal Products Worldwide
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1. Aged 18 years and over
2. Fitzpatrick Skin Type I, II, or III
3. Must be able to read and follow study instructions in English
4. Generally in good health as determined by the investigator or designee, based on
collected medical history.
5. Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days after study completion. Females must have used such birth control for at least 3 months prior to Visit 1
6. Willing and able to follow the study instructions
7. Evidence of personally read, signed, and dated Photograph Release and Informed Consent Form (including HIPAA disclosure) indicating that the subject has been informed of and understands all pertinent aspects of the trial and is willing to participate
1. Known allergies or sensitivities to topical products or ingredients in the study products
2. A history of abnormal responses to sunlight (e.g. phototoxic or photoallergic response)
3. Presence of sunburn (i.e. clinical score greater than 0), suntan, scars, tattoos, active dermal lesions, dysplastic nevi, uneven skin tone, damaged/broken skin, or excessive body hair* on the areas of skin to be evaluated
4. On the morning of or during study visits: has applied a topical product (including sunscreen, moisturizers, makeup, etc.) to the areas of skin to be evaluated (other than provided sunscreen, if applicable)
5. Taking/using systemic or topical medication that is known to alter responses to UV radiation
6. Has a concurrent illness, a medical history of a disease/condition, or a preexisting/dormant dermatologic condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could interfere with the outcome of the study or increase health risk to the subject, as determined by the investigator or designee
7. Female subject who (to the best of her knowledge) is pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion
8. Individuals viewed by the investigator or designee as not being able to complete the study
9. Individuals who are currently participating in another clinical study or who have participated in any other clinical study in the past 4 weeks at any testing facility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical evaluation of sunburn is completed by a randomization-blinded clinician on a numerical rating scale approximately 24 hours after sun exposure
- Secondary Outcome Measures
Name Time Method Amount/weight of sunscreen product used is recording using weighing scales at baseline and following the end of sun exposure (sunscreen group only)