Test the Outdoor Usage for Sunscreen Products in Female Adults

Study Overview
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Brief Summary
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To assess the safety of a sunscreen product when used outdoor.

Official Title
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Supervised Outdoor -Use Test for Sunscreen Products in Female Adults

Conditions
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Sunscreening Agents

Intervention / Treatment
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* Drug: BAY987518
* Drug: Sunscreen Lotion (U77-030 Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin. Subjects must have Fitzpatrick Skin Types I, II, III, or IV. Subjects must agree to restrict their sun exposure activities for at least five days. Subjects must be willing and physically able to spend approximately 3 continous hours in the sun. Exclusion Criteria: Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history. Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn. Subjects must not have significantly tanned skin. Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987518<br>Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. | Drug: BAY987518<br>* Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. Formulation: V27-104<br>|
| Active Comparator: Sunscreen control<br>Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. | Drug: Sunscreen Lotion (U77-030 Control)<br>* Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 |  | After approximately three hours direct sun-exposure |