Back to results4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness
Primary Purpose
Rosacea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coppertone, BAY1183345
Sponsored by
About this trial
This is an interventional supportive care trial for Rosacea focused on measuring Facial redness, Skin sensitivity
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.
Sites / Locations
- The Education & Research Foundation, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sunscreen Lotion
Arm Description
Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks
Outcomes
Primary Outcome Measures
Number of subjects exhibiting increases in papules
Number of subjects exhibiting increases in erythema
Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
Number of subjects exhibiting increases in any subjective irritation
Secondary Outcome Measures
Change in facial redness measured by spectrophotometer
Change in facial redness measured by digital imaging
Percentages for each response to hedonic questionnaire assessing product experience
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03841032
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Facial redness, Skin sensitivity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunscreen Lotion
Arm Type
Experimental
Arm Description
Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Coppertone, BAY1183345
Intervention Description
Lotion, for 4 weeks
Primary Outcome Measure Information:
Title
Number of subjects exhibiting increases in papules
Time Frame
Up to 4 weeks
Title
Number of subjects exhibiting increases in erythema
Time Frame
Up to 4 weeks
Title
Number of subjects exhibiting increases in dryness, telangiectasia and tactile surface roughness
Time Frame
Up to 4 weeks
Title
Number of subjects exhibiting increases in any subjective irritation
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Change in facial redness measured by spectrophotometer
Time Frame
From baseline up to 4 weeks
Title
Change in facial redness measured by digital imaging
Time Frame
From baseline up to 4 weeks
Title
Percentages for each response to hedonic questionnaire assessing product experience
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Learn more about this trial
4 Week In-Use Study Evaluating How Well-Tolerated a Skin Care Product Is on Adults With Facial Redness
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