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

NCT03841032 | Completed

• 1 other identifier: 20516
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rosacea

Keywords

Facial redness; Skin sensitivity

Outcome Measures

Primary Outcomes (4)

• Number of subjects exhibiting increases in papules

  Up to 4 weeks

• Number of subjects exhibiting increases in erythema

  Up to 4 weeks

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

  Up to 4 weeks

• Number of subjects exhibiting increases in any subjective irritation

  Up to 4 weeks

Secondary Outcomes (3)

• Change in facial redness measured by spectrophotometer

  From baseline up to 4 weeks

• Change in facial redness measured by digital imaging

  From baseline up to 4 weeks

• Percentages for each response to hedonic questionnaire assessing product experience

  Up to 4 weeks

Study Arms (1)

Sunscreen Lotion

EXPERIMENTAL

Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks

Drug: Coppertone, BAY1183345

Interventions

Coppertone, BAY1183345 DRUG

Lotion, for 4 weeks

Sunscreen Lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 15, 2019
• Study Start: January 28, 2019
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

US (1)