Test the Outdoor Usage for Sunscreen Products in Female Adults

NCT02779270 | Completed

• 1 other identifier: 18318
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3

  After approximately three hours direct sun-exposure

Study Arms (2)

BAY987518

EXPERIMENTAL

Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.

Drug: BAY987518

Sunscreen control

ACTIVE COMPARATOR

Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.

Drug: Sunscreen Lotion (U77-030 Control)

Interventions

BAY987518 DRUG

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

BAY987518

Sunscreen Lotion (U77-030 Control) DRUG

Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

Sunscreen control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 20, 2016
• Study Start: September 26, 2015
• Primary Completion: September 27, 2015
• Study Completion: September 27, 2015
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)