Supervised Outdoor-Use Test For Sunscreen Products in Adults

Sunscreening Agents Clinical Trial

Official title:

Supervised Outdoor-Use Test For Sunscreen Products in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877511
• Other study ID #: 18803
• Status: Completed
• Phase: N/A
• Start date: August 20, 2016
• Est. completion date: August 21, 2016

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 under supervised outdoor-use conditions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 21, 2016
• Est. primary completion date: August 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• BAY987517
Applied liberally to the skin (Formulation: Y73-161
• Sunscreen Lotion (Y65-110)
Applied liberally to the skin

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		From the beginning of the study until 24 hours after study

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