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OpenTrials
Completed

NCT Number: NCT02779270

Test the Outdoor Usage for Sunscreen Products in Female Adults

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

Completed

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Key information

Conditions

Sunscreening Agents

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: After approximately three hours direct sun-exposure

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Supervised Outdoor -Use Test for Sunscreen Products in Female Adults

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 20, 2016
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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