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Completed

NCT Number: NCT03392558

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

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).

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Burt's Bees Skin Care Regimen

Other

Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime)

Control Regimen

Other

Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Burt's Bees Inc.

Industry

Collaborators

  • Dermatology Consulting Services, High Point NC

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 8, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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