To evaluate the long-term safety of omiganan topical gel applied once daily to the face of subjects with papulopustular rosacea
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events (AE) throughout the study at Month 1, 3, 6, 9, 12.
Secondary outcome
Not applicable
Background summary
There is no cure for rosacea and treatment is aimed at alleviating the
symptoms. Topical or oral medications are generally prescribed for mild to
moderate papulopustular rosacea. The topical medications include:
metronidazole, azelaic acid, ivermectin, sodium sulfacetamide and sulfur,
erythromycin, and tretinoin. Oral medications prescribed for severe disease
include doxycycline at microbial and subantimicrobial doses and, minocycline.
Isotretinoin, although not FDA approved for the treatment of rosacea, has also
been prescribed when other agents have failed. In particular, treatments for
severe rosacea are inadequate, and isotretinoin use has been recommended with
increasing frequency in this patient population. Hence, topical Omiganan has
the potential to become an important addition to the dermatologist*s
armamentarium in treating severe rosacea.
The exact cause of rosacea is unknown and may be in due in part to an
inflammatory process. Recent research has shown that cationic peptides such as
omiganan may have anti-inflammatory properties and may play a role in
inhibiting the inflammatory response. Omiganan may also prevent the
inflammatory cascade that is theorized to lead to the signs and symptoms of
rosacea. A possible anti-inflammatory activity of omiganan is suggested by the
observation of a reduction in inflammatory acne lesion counts with omiganan in
two Phase 2 clinical trials. However, the exact mechanism of action is
undetermined.
Omiganan pentahydrochloride topical gel has been evaluated in human clinical
studies at concentrations of 0.5%, 1.0%, 2.5% and 3% in Phase 1 studies; at
concentrations of 1.0%, 1.75% and 2.5% in Phase 2 studies; and at
concentrations of 1.0% in a Phase 3 study. In these studies, including two
Phase 2 studies of omiganan topical gel applied to the face of subjects with
moderate to severe papulopustular rosacea, omiganan was found to be safe, and
well tolerated. In the most recent Phase 2 study in which vehicle or omiganan
pentahydrochloride topical gel 1.0%, 1.75% or 2.5% was applied once daily to
the face of 240 moderate to severe rosacea subjects for 12 weeks, the most
frequently reported adverse events were headache, sinusitis, and upper
respiratory tract infections. Most treatment emergent adverse events were
considered mild or moderate in severity.
Study objective
To evaluate the long-term safety of omiganan topical gel applied once daily to
the face of subjects with papulopustular rosacea
Study design
Open-label, multi-center, long-term safety study
Intervention
Blood sample (venopuncture): 4 times during the course of the study (minimum 6
ml and maximum 17 ml each time).
Study burden and risks
Please refer to Information Sheet for participants
Liberty Ridge, Suite 3000 1500
Wayne 19087
US
Liberty Ridge, Suite 3000 1500
Wayne 19087
US
Listed location countries
Age
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.
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. ;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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002921-20-NL |
| CCMO | NL55273.072.15 |