Clinical trial NCT03841032: 4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness
Official title: 4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Keywords: Facial redness
Skin sensitivity
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects exhibiting increases in papules
timeFrame: Up to 4 weeks
measure: Number of subjects exhibiting increases in erythema
timeFrame: Up to 4 weeks
measure: Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
timeFrame: Up to 4 weeks
measure: Number of subjects exhibiting increases in any subjective irritation
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Change in facial redness measured by spectrophotometer
timeFrame: From baseline up to 4 weeks
measure: Change in facial redness measured by digital imaging
timeFrame: From baseline up to 4 weeks
measure: Percentages for each response to hedonic questionnaire assessing product experience
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
Study officials:
References: