Supervised Outdoor-Use Test For Sunscreen Products in Adults

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: BAY987517; Drug: Sunscreen Lotion (Y65-110)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02877511

18803

Details and patient eligibility

About

To assess the safety of a sunscreen product under supervised outdoor-use conditions

Enrollment: 102 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject must be healthy, males or females between 18 to 65 years of age with no medical conditions of the skin.
• Subjects must have Fitzpatrick Skin Type I, II, III or IV.
• Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion criteria

• Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
• Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
• Subjects must not have significantly tanned skin.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Arm 1

Experimental group

Description:

2/3 of subjects testing the test article

Treatment:

Drug: BAY987517

Arm 2

Active Comparator group

Description:

1/3 of subjects testing the marketed control

Treatment:

Drug: Sunscreen Lotion (Y65-110)