E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Papulopustular Rosacea is a chronic dermatologic disorder that primarily affects the facial skin with inflammatory papules and pustules. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039218 |
E.1.2 | Term | Rosacea |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety of omiganan topical gel applied once daily to the face of subjects with papulopustular rosacea. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints Summaries will be presented to determine long-term safety in place of conducting statistical testing. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Adverse events (AE) throughout the study at Month 1, 3, 6, 9, 12. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
France |
Netherlands |
New Zealand |
Sweden |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The definition of the end of the study in the protocol is LVLS. Please note if any subject has a positive confirmatory antidrug antibody result they will be followed for up to 1 year from discovery to allow for antibody levels to return to baseline. Any subjects with positive confirmatory antidrug antibody results who have completed the study or discontinued from the study for any reason, will be contacted and requested to return to the clinical study site for additional immunogenicity testing. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |