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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02779270
Other study ID # 18318
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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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