Test the Outdoor Usage for Sunscreen Products in Female Adults

Sunscreening Agents Clinical Trial

Official title:

Supervised Outdoor -Use Test for Sunscreen Products in Female Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779270
• Other study ID #: 18318
• Status: Completed
• Phase: N/A
• Start date: September 26, 2015
• Est. completion date: September 27, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 27, 2015
• Est. primary completion date: September 27, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• BAY987518
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
• Sunscreen Lotion (U77-030 Control)
Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3		After approximately three hours direct sun-exposure

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