Test the Outdoor Usage for Sunscreen Products in Female Adults

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: Sunscreen Lotion (U77-030 Control); Drug: BAY987518

Study type: Interventional

Funder types: Industry

Identifiers

NCT02779270

18318

Details and patient eligibility

About

To assess the safety of a sunscreen product when used outdoor.

Enrollment: 105 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

BAY987518

Experimental group

Description:

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.

Treatment:

Drug: BAY987518

Sunscreen control

Active Comparator group

Description:

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.

Treatment:

Drug: Sunscreen Lotion (U77-030 Control)