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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03841032

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Coppertone, BAY1183345	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 28, 2019

Actual Primary Completion Date :

Feb 25, 2019

Actual Study Completion Date :

Feb 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sunscreen Lotion Subjects with rosacea will apply the test sunscreen lotion to the face for 4 weeks	Drug: Coppertone, BAY1183345 Lotion, for 4 weeks

Arm

Intervention/Treatment

Experimental: Sunscreen Lotion

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

Drug: Coppertone, BAY1183345

Lotion, for 4 weeks

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Education & Research Foundation, Inc.	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT03841032

Other Study ID Numbers:

20516

First Posted:

Feb 15, 2019

Last Update Posted:

Jun 12, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Bayer

Facial redness

Skin sensitivity

Additional relevant MeSH terms:

Rosacea

Study Results

No Results Posted as of Jun 12, 2019