To Assess the Safety of a Sunscreen Product

NCT02803320 | Completed

• 1 other identifier: 18309
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sunscreening Agents

Keywords

Sunscreen active

Outcome Measures

Primary Outcomes (2)

• Dermatologist´s subjective and objective assessments of potential Adverse events

  • "product related," • "likely product related," • "unlikely product related, or "not product related.

  2 days

• 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

Study Arms (1)

SPF 50 Y65 110

EXPERIMENTAL

All subjects received baseline skin evaluation and 1 day of sun exposure.

Drug: SPF 50 Y65 110 (BAY 987516)

Interventions

SPF 50 Y65 110 (BAY 987516) DRUG

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.

SPF 50 Y65 110

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: May 27, 2015
• Primary Completion: May 29, 2015
• Study Completion: May 31, 2015
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)