check_circleStudy Completed

Rosacea

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
35
Trial Dates
January 2019 - February 2019
Phase
N/A
Could I Receive a placebo
No
Products
BAY1183345
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
The Education & Research Foundation, Inc.Lynchburg, 24501, United States

Primary Outcome

  • Number of subjects exhibiting increases in papules
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects exhibiting increases in erythema
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
    date_rangeTime Frame:
    Up to 4 weeks
  • Number of subjects exhibiting increases in any subjective irritation
    date_rangeTime Frame:
    Up to 4 weeks

Secondary Outcome

  • Change in facial redness measured by spectrophotometer
    date_rangeTime Frame:
    From baseline up to 4 weeks
  • Change in facial redness measured by digital imaging
    date_rangeTime Frame:
    From baseline up to 4 weeks
  • Percentages for each response to hedonic questionnaire assessing product experience
    date_rangeTime Frame:
    Up to 4 weeks

Trial design

4 Week In-Use Study Evaluating the Tolerability of a Skin Care Product on Adults with Rosacea
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Supportive Care
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1