Sunburn Skin and Connective Tissue Diseases Sunburn
Conditions
Interventions
At baseline, seven exposed skin areas (face, upper chest, back of the neck, both arms and legs) are examined. To qualify, participants are required to have no evidence of sunburn. Eligible participant
1 - possible sunburn-not clearly defined
2 - defined redness clearly UV caused
3 - severe sunburn-pronounced redness
4 - edema and/or blisters). Photos are obtained for the sites >=grade 2.
Sponsors
Johnson & Johnson Consumer & Personal Products Worldwide
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation of sunburn is completed by a randomization-blinded clinician on a numerical rating scale approximately 24 hours after sun exposure | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount/weight of sunscreen product used is recording using weighing scales at baseline and following the end of sun exposure (sunscreen group only) | — |
Countries
United States of America
Contacts
Public ContactAaron Farberg
Outcome results
None listed