Papulopustular rosacea MedDRA version: 19.1 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Cutanea Life Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who provided written informed consent to participate in the study. 2. Healthy, male and non-pregnant female subjects, 18 years of age or older. 3. A diagnosis of papulopustular rosacea with =30 inflammatory facial lesions (papules, pustules) at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline. 4. Subjects with the presence of telangiectasia at Baseline. 5. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema (IAE) scale at Baseline. 6. Subjects with a grade 4 (severe rosacea) on the 5-point Investigators Global Assessment (IGA) scale at Baseline. 7. Non-nursing, female subjects of child bearing potential, who are using a highly effective form of birth control or females not of childbearing potential due to menopause (must be postmenopausal for at least one year). Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Forms of birth control include: Oral (birth control pills), Intravaginal: (e.g. NuvaRing®), Implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or transdermal (e.g Ortho Evra®) contraception; intrauterine device (IUD); double-barrier (diaphragm or condom with spermicidal gel or foam); for two months prior to study enrollment (see exclusion criteria #6) or a vasectomized partner or true abstinence (in line with preferred and usual lifestyle of subject) with an acceptable form of birth control should the subject become sexually active. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. All female subjects of child bearing potential must undergo an in-office, highly sensitive urine pregnancy test, with a negative result, prior to being randomized to receive study drug. In addition, women of childbearing potential must agree to have a highly sensitive urine pregnancy test at the end of the study. 8. Subjects who have used the same brand of soap, make-up, hair products, or shaving lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit and agree not to change these product brand/types during the study. 9. Male subjects who are willing to shave, if applicable, at approximately the same time every day. 10. Subjects who are willing and able to return to the study clinic for the designated study visits. 11. Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or excessive exposure to the sun for the duration of the study. 12. Subjects who are willing to comply with the protocol and visit requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant abnormal findings at the Baseline/Day 1 Visit that would require a new intervention or treatment, or a change in treatment that would in the opinion of the investigator supersede participation in the clinical trial. 2. Subjects with steroid rosacea or subtype 3 (phymatous rosacea). 3. Subjects with nodular rosacea (defined as more than 2 lesions greater than 5 mm). 4. Subjects with underlying diseases or other dermatological conditions, such as; atopic dermatitis, perioral dermatitis, or seborrheic dermatitis, which requires the use of interfering topical or systemic therapy or may interfere with the rosacea diagnosis or its assessment. 5. Subjects using concomitant treatments that may influence study end points within 2 weeks of Baseline Visit (e.g., facial or chemical peels, dermal fillers, acne surgery, intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray, laser therapy or UV therapy). 6. If using estrogens or progesteronal agents (e.g, Gynogen, Valergen, Depo-Testadiol, Depogen, birth control pills), for less than 2 months prior to the Baseline Visit. (Subjects using estrogens for 2 months or more need not be excluded unless the subject expects to change dose, drug, or discontinue estrogen use during the study. See Inclusion #7.) 7. Subjects with known allergies to the active ingredient or any of the excipients. (See Section 7.6.2) 8. Subjects who have not undergone the specified washout period(s) for the following topical preparations applied to the face or subjects who require the concomitant use of any of the following topical preparations/treatments applied to the face: Product Washout Period (Prior to Baseline/First Dose) ? Abradants, astringents, toners, facials, masks, or moisturizers containing retinols, AHA (alpha hydroxyl acids), salicylic acids, 1 week ? Tanning booths/beds 2 weeks ? Antibiotics (other than topical ocular application) 2 weeks ? Antimicrobial soaps 2 weeks ? Corticosteroids 2 weeks ? Other anti-inflammatories 2 weeks ? Other rosacea treatments (e.g. azelaic acid, metronidazole, ivermectin, sulfacetamide,) 2 weeks ? Retinoids 4 weeks 9. Subjects who have not undergone the specified washout period(s) for the following systemic treatments or subjects who require the concomitant use of any of the following systemic treatments: Product Washout Period (Prior to Baseline/First Dose) ? Antibiotics 4 weeks ? Corticosteroids 4 weeks ? Retinoids 12 weeks 10. Female subjects who are pregnant, nursing, or planning a pregnancy within the study period. 11. Subjects who have a beard, or excessive facial hair. A moustache will be allowed, if in the investigator’s judgment it does not impair the assessment of rosacea. 12. Subjects using an investigational drug within 30 days of the Baseline Visit or who are currently participating in an investigational study. Use of an investigational drug/device and/or participation in another investigational study is prohibited during this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of once-daily application of omiganan topical gel compared to vehicle gel in subjects with severe papulopustular rosacea (IGA grade 4 with baseline inflammatory lesion count = 30).;Secondary Objective: Secondary objectives include evaluation of the long term safety of omiganan topical gel.; Primary end point(s): The primary objective of the study is to show superiority of Omiganan over vehicle for the treatment of rosacea in patients with severe papulopustular rosacea (IGA grade 4 with baseline inflammatory lesion count = 30). A sample size calculation was made for two co-primary endpoints. For change from baseline in inflammatory lesions, it is assumed that in the Omiganan treatment arm, subjects will have an average reduction of 13.5 inflammatory lesions, compared to 4 in the vehicle arm. The standard deviation is assumed to be 12. For 95% power, a sample size of 86 subjects (43 per group) is needed. For IGA, it is assumed that Clear or Almost Clear (IGA of 0 or 1) at Week 12 has lesser power than 2 grade (point) reduction. It is also assumed that 17% of the subjects in the omiganan treatment arm versus 6% in the vehicle arm will have an IGA of clear or almost clear at Week 12. For 95% power and using a Fisher’s Exact test, 450 subjects (225 in each arm) are needed. Therefore, the number of subjects needed to ensure at least 95% power for both endpoints is 450. The sample sizes were calculated using 95% power in order to ensure 90% power across two Phase 3 studies. Co-primary Endpoints o The absolute change from Baseline to Week 12 in inflammatory lesions. o IGA at Week 12: 2 grade reduction; Clear or Almost Clear (IGA 0 or 1). Safety: Adverse events (AE) throughout the study; vital signs at Screening, Week 6 and Week 12. Physical Exam (PE), and Safety labs at Screening and Week 12. Immunogenicity will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints o The absolute change from baseline to Week 9 in inflammatory lesions (papules and pustules). The absolute change from baseline to Week 6 in inflammatory lesions (papules and pustules). o IGA at Week 9: 2 point reduction; Clear or Almost Clear (IGA 0, 1). o IGA at Week 6: 2 point reduction; Clear or Almost Clear (IGA 0, 1). ;Timepoint(s) of evaluation of this end point: Week 6/9 of treatment for each patient. | — |
Countries
Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Cutanea Life Sciences, Inc.
Outcome results
None listed