A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects with Rosacea

Phase 1

Conditions: Papulopustular Rosacea
MedDRA version: 19.1 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-002921-20-GB

Lead Sponsor: Cutanea Life Sciences, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

1. Subjects who have provided written informed consent to participate in the study.
2. Healthy, male and nonpregnant female subjects, 18 years of age or older.
3. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment (IGA) grading scale (Grade 4; described as numerous (=20) small and or large inflammatory papules/ pustules, and up to 2 nodules, (at baseline))
4. Subjects with the presence of telangiectasia at Baseline
5. Subjects with the presence of facial erythema associated with their rosacea at Baseline
6. 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 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 receiving study drug. In addition, women of childbearing potential must agree to have a highly sensitive urine pregnancy test at the end of the study.
7. Subjects who are willing and able to return to the study clinic for the designated study visits.
8. 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.
9. 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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Subjects with clinically significant abnormal findings at the Screening or 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 with known allergies to the active ingredient or any of the excipients. (See Section 7.5.2)
6. 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
7. 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 4 weeks
8. Female subjects who are pregnant, nursing, or planning a pregnancy within the study period.
9. 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.
10. Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse with in the past year.
11. Subjects who have a chronic medical condition that may require the use of a prohibited medication to treat new symptoms or exacerbations, for example, rheumatoid arthritis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of omiganan topical gel applied once daily to the face of subjects with papulopustular rosacea.;Secondary Objective: Not applicable;<br> Primary end point(s): Safety Endpoints<br> Summaries will be presented to determine long-term safety in place of conducting statistical testing.<br> ;Timepoint(s) of evaluation of this end point: Adverse events (AE) throughout the study at Month 1, 3, 6, 9, 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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