Clinical trial NCT03392558: The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
Official title: The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Lead sponsor: Burt's Bees Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dermatology Consulting Services, High Point NC
First posted: 2018-01-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility 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.

Primary outcomes:
measure: Investigator Global Assessment of Rosacea Scale Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Overall Skin Quality
timeFrame: 4 weeks
Other outcomes:
measure: Transepidermal Water Loss
timeFrame: 4 weeks
measure: Corneometry
timeFrame: 4 weeks
Locations:
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
Study officials:
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe D Draelos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draelos ZD, Gunt H, Levy SB. Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea. J Drugs Dermatol. 2019 Feb 1;18(2):141-146.