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Completed

NCT Number: NCT03841032

4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness

The purpose of this study is to evaluate if the test sunscreen skin care product will be well-tolerated and help facial redness when applied to the face after 4 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or females at least 18 years of age;
  • Women of childbearing potential must agree to use adequate contraception when sexually active. Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception (stable dose for 3 months); (v) partner vasectomy.
  • Subjects with general good health as determined by a medical history form;
  • Subjects with erythematotelangiectatic and/or papulopustular rosacea, at the baseline evaluation, as determined by the Investigator;
  • Subjects with Fitzpatrick Skin Types I through III, as determined by the dermatologist;
  • Subjects willing and capable of understanding and providing written informed consent, willing to sign a confidentiality agreement, Health Insurance Portability and Accountability Act (HIPAA) Authorization Form, and to cooperate and participate by following study requirements.

Exclusion criteria

  • Subjects with only phymatous or ocular rosacea;
  • Female subjects of child-bearing potential who test positive in a urine pregnancy test at Baseline (Visit 1), are trying to become pregnant or are nursing;
  • Subjects with known allergies to any type of skin care product and/or sunscreen product and/or any ingredients in the test product;
  • Subjects with any facial skin disorders which may influence results, in the opinion of the Investigator;
  • Subjects with a reported history of acute or chronic dermatological (except for rosacea), uncontrolled hypertension, other medical and/or physical conditions which, in the opinion of the Investigator, interferes with evaluation of the test product or places the subject at risk;
  • Subjects currently using medications or oral supplements which, in the opinion of the Investigator, may influence the outcome of the study or interfere with study observations, including rosacea treatment products;
  • Individuals using or who have used any systemic medication considered to affect rosacea, specifically, but not exclusively, antibiotics or steroids, who do not agree to continue taking the specified medication at the same dose and regimen throughout the study;
  • Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study;
  • Subjects with excessive facial hair that would, in the opinion of the Investigator, interfere with diagnosis or assessment of rosacea;
  • Subjects who spend excessive time out in the sun;
  • Subjects that have received or used an Investigational New Drug within 30 days prior to the study.

Treatment and study plan

Coppertone, BAY1183345

Drug

Lotion, for 4 weeks

Primary outcomes

  1. Number of subjects exhibiting increases in papules

    Time frame: Up to 4 weeks

  2. Number of subjects exhibiting increases in erythema

    Time frame: Up to 4 weeks

  3. Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness

    Time frame: Up to 4 weeks

  4. Number of subjects exhibiting increases in any subjective irritation

    Time frame: Up to 4 weeks

Secondary outcomes

  1. Change in facial redness measured by spectrophotometer

    Time frame: From baseline up to 4 weeks

  2. Change in facial redness measured by digital imaging

    Time frame: From baseline up to 4 weeks

  3. Percentages for each response to hedonic questionnaire assessing product experience

    Time frame: Up to 4 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults With Rosacea

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Jun 12, 2019

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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