The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea

Study Overview
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Brief Summary
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This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).

Official Title
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The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Other: Burt's Bees Skin Care Regimen
* Other: Control Regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be female 25-60 years of age with moderate facial rosacea at screening and 6 or 7 papules and/or pustules; as well as, no other known medical conditions that, in the investigator's opinion, may interfere with study participation. Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant(R), Depo-Provera(R) double barrier methods (e.g., condom and spermacide) and abstinence. Subjects must provide written informed consent. Willingness to comply with the study design and procedures. Subjects who agree to sign a photography release form. Exclusion Criteria: Any dermatological disorder, except rosacea requiring the use of prescription medication, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, Subjects who are using any anti-aging skin care products within 4 weeks of study enrollment. Subjects who are not willing to use only the assigned study products and nothing else, except for self-selected colored cosmetics that must remain unchanged during the study, to their face. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. Subjects, who are pregnant, breast feeding, or planning a pregnancy. Subjects with clinically significant unstable medical disorders. Subjects who are unwilling or unable to comply with the requirements of the protocol. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. Subjects who have participated in any clinical study in the past 30 days or are currently participating in any other clinical study. Subjects with any planned surgeries and/or invasive medical procedures during the course of 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 who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day. Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork. Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nature-Based Sensitive Skin Regimen<br>Burt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR): Burt's Bees Sensitive Facial Cleanser (to be used day and night) Burt's Bees Sensitive Daily Moisturizing Cream (to be used in the day) Burt's Bees Sensitive Night Cream (to be used at night) | Other: Burt's Bees Skin Care Regimen<br>* Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime)<br>|
| Active Comparator: Control Regimen<br>Control Skin Care Regimen (Control Regimen, CR): Cetaphil Gentle Skin Cleanser (to be used day and night) Cetaphil Moisturizing Lotion (to be used day and night) | Other: Control Regimen<br>* Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment of Rosacea Scale Score | The primary efficacy endpoint is no increase in the cumulative Investigator Global Assessment of Rosacea Scale score, measured at Week 4 from baseline | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Skin Quality | The secondary efficacy endpoint is at least no increase in the Overall Skin Quality domain of the Subject-Rated Efficacy Scale score, measured at Week 4 from baseline | 4 weeks |