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

June 19, 2018 updated by: Burt's Bees Inc.
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).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nature-Based Sensitive Skin Regimen

Burt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR):

  1. Burt's Bees Sensitive Facial Cleanser (to be used day and night)
  2. Burt's Bees Sensitive Daily Moisturizing Cream (to be used in the day)
  3. Burt's Bees Sensitive Night Cream (to be used at night)
Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime)
Active Comparator: Control Regimen

Control Skin Care Regimen (Control Regimen, CR):

  1. Cetaphil Gentle Skin Cleanser (to be used day and night)
  2. Cetaphil Moisturizing Lotion (to be used day and night)
Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator Global Assessment of Rosacea Scale Score
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transepidermal Water Loss
Time Frame: 4 weeks
No increase in transepidermal water loss values measured at Week 4 from baseline
4 weeks
Corneometry
Time Frame: 4 weeks
No decrease in corneometry values at Week 4 from baseline
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Zoe D Draelos, MD, Dermatology Consulting Services, High Point NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCS-25-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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