To Assess the Safety of a Sunscreen Product

Sunscreening Agents Clinical Trial

Official title:

Supervised Outdoor -Use Test to Assess the Safety of a Sunscreen Lotion on Sports Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803320
• Other study ID #: 18309
• Status: Completed
• Phase: N/A
• Start date: May 27, 2015
• Est. completion date: May 31, 2015

Study information

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

Clinical Trial Summary

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 31, 2015
• Est. primary completion date: May 29, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects' dermatological medical history.

• The subject must have Fitzpatrick skin types I to VI.

• During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure

• Subjects must agree to refrain from alcohol and tobacco use during the course of the study

• Subjects must obey all rules of the test facility

• Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• SPF 50 Y65 110 (BAY 987516)
Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout.

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	Dermatologist´s subjective and objective assessments of potential Adverse events	• "product related," • "likely product related," • "unlikely product related, or "not product related.	2 days
Primary	Final Skin Evaluation	• Score 0 (no response): Normal skin. No visible response or erythema. up to Score 3 (severe response): A well demarcated area of very intense or "beet" red erythema or an area of the skin affected by significant edema, papules, and/or vesicles. Usually symptomatic and may require therapeutic intervention.	2 days

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