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



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:25 - 60
Updated:6/23/2018
Start Date:January 1, 2018
End Date:May 1, 2018

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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).


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.
We found this trial at
1
site
High Point, North Carolina 27262
Principal Investigator: Zoe D Draelos, MD
Phone: 336-841-2040
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mi
from
High Point, NC
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