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 |
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).
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
Click here to add this to my saved trials