Last updated: August 4, 2023
Sponsor: Goldman, Butterwick, Fitzpatrick and Groff
Overall Status: Active - Not Recruiting
Phase
3
Condition
Hives (Urticaria)
Skin Wounds
Rash
Treatment
Barrier Renew
Clinical Study ID
NCT05961579
ROC-Rosacea-2023
Ages 18-60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women between the ages of 18 and 60 years old (inclusive)
- Subjects must be able and willing to provide written informed consent and photographyrelease
- At the baseline evaluation, all subjects must exhibit all of the following:
- Mild to moderate confluent facial redness or blotchy redness
- Mild to moderate score (1-6) for tactile roughness or dryness.
- Subject must be in good general health with no other skin disease, disease state orphysical condition which would impair evaluation of the areas to be treated or whichwould increase the subject's health risk by study participation.
- Subjects must have a willingness to minimize sun exposure, avoid direct sun exposureon the face, and avoid the use of tanning beds for the entire duration of the study.Must be willing to wear a hat and reapply sunscreen if sun exposure is unavoidable.
- Subjects must be willing and able to understand and comply with the requirements ofthe study including minimizing external factors that might trigger redness flare-ups (e.g. spicy foods, excessively hot or cold environments, prolonged sun exposure,strong winds and alcoholic beverages), apply the products as instructed, return forthe required treatment period visits, comply with therapy prohibitions, and be able tocomplete the study.
- For female subjects of childbearing potential, must be willing to use an acceptableform of birth control during the entire course of the study. All systemic birthcontrol measures must be in consistent use for at least 30 days prior to studyenrollment.
- A female is considered of childbearing potential unless she is postmenopausal,without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptivepatches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g.,condoms and spermicide), abstinence, and/or vasectomy of partner with adocumented second acceptable method of birth control, should the subject becomesexually active.
Exclusion
Exclusion Criteria:
- Subjects who are pregnant, planning a pregnancy, or nursing a child.
- Subject using systemic or topical anti-inflammatory agents with the exception of OTCacetaminophen (e.g., Tylenol), ibuprofen (e.g., Advil), or aspirin for 5 days prior tothe baseline visit and the duration of the trial
- Subject who could not agree to not use systemic or topical anti-inflammatory agents,with the exception of OTC acetaminophen (e.g., Tylenol), ibuprofen (e.g., Advil), oraspirin during the course of the study.
- Subjects who exhibit severe or advanced redness (persistent deep erythema,telangiectasia forming sprays, papules, pustules, nodules with variable plaque-likeedema, or phymatous change).
- Subjects who have used a personal product on the face prior to the study start, whichin the opinion of the investigator could interfere with the evaluation of the testarticles in the time frame below
- Retinoids and other vitamin A derivatives within 1 month
- Exfoliating and/or keratolytic products including alpha- or beta-hydroxy acidswithin 2 weeks
- Subjects who have taken a medication prior to the study start, which in the opinion ofthe investigator could interfere with the evaluation of the test articles. Thesemedications may include, but are not limited to, the use of any medication to treatrosacea, oral or topical antibiotics, steroids, antifungals, antimicrobials or acnemedications for two weeks prior to study start or the time period specified below
- Systemic retinoids within 6 months
- Systemic tetracycline class antibiotics within 2 months
- Systemic macrolide antibiotics within 4 weeks
- Initiation of change in hormonal therapy within 3 months
- Subjects with a recent history of atopic dermatitis/eczema or contact dermatitis
- Subjects who are currently under treatment for asthma or diabetes.
- Subjects with any medical condition of the face that could interfere with the study
- Subjects with facial piercings or tattoos that in the Investigator's opinion may hidethe diagnosis or disrupt the treatment. Subject agrees not get any facial piercings ortattoos during the study.
- Subjects who are not willing to remove jewelry (earrings), make up and falseeyelashes/lash extensions prior to photography.
- Ocular involvement, such as conjunctivitis, episcleritis, iritis, or keratitis.
- History of hypersensitivity or allergy to any of the product ingredients.
- Laser, chemical peel, or surgery on the facial area within 3 months prior to baseline.
- Recent history (<1 year) of substance use disorder
- Subjects that have participated in a clinical research trial in the past 30 days.
Study Design
Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Barrier Renew
Phase: 3
Study Start date:
August 11, 2023
Estimated Completion Date:
November 30, 2023