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

NCT03392558 | Completed

• 1 other identifier: DCS-25-17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment of Rosacea Scale Score

  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 Outcomes (1)

• Overall Skin Quality

  4 weeks

Other Outcomes (2)

• Transepidermal Water Loss

  4 weeks

• Corneometry

  4 weeks

Study Arms (2)

Nature-Based Sensitive Skin Regimen

EXPERIMENTAL

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

Control Regimen

ACTIVE COMPARATOR

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

Interventions

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)

Nature-Based Sensitive Skin Regimen

Control Regimen OTHER

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

Control Regimen

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burt's Bees Inc.: lead
• Dermatology Consulting Services, High Point NC: collaborator

Study Sites (1)

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Related Publications (1)

• 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.

  PMID: 30794364 DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zoe D Draelos, MD

  Dermatology Consulting Services, High Point NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 8, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2018
• Study Completion: May 1, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)