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

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ClinicalTrials.gov Identifier: NCT03392558
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
Dermatology Consulting Services, High Point NC
Information provided by (Responsible Party):
Burt's Bees Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Rosacea Other: Burt's Bees Skin Care Regimen Other: Control Regimen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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)
Other: Burt's Bees Skin Care Regimen
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)
Other: Control Regimen
Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Transepidermal Water Loss [ Time Frame: 4 weeks ]
    No increase in transepidermal water loss values measured at Week 4 from baseline

  2. Corneometry [ Time Frame: 4 weeks ]
    No decrease in corneometry values at Week 4 from baseline



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392558


Locations
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United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Burt's Bees Inc.
Dermatology Consulting Services, High Point NC
Investigators
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Principal Investigator: Zoe D Draelos, MD Dermatology Consulting Services, High Point NC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Burt's Bees Inc.
ClinicalTrials.gov Identifier: NCT03392558     History of Changes
Other Study ID Numbers: DCS-25-17
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rosacea
Skin Diseases