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

NCT ID: NCT03392558

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-05-01

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).

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Burt's Bees Skin Care Regimen

Intervention Type: 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

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)

Group Type: ACTIVE_COMPARATOR

Control Regimen

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: OTHER

Control Regimen

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dermatology Consulting Services, High Point NC

OTHER

Sponsor Role: collaborator

Burt's Bees Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoe D Draelos, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Consulting Services, High Point NC

Locations

Dermatology Consulting Services

High Point, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30794364 (View on PubMed)

Other Identifiers

DCS-25-17

Identifier Type: -

Identifier Source: org_study_id