Phase 3
Completed N=307
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
Rosacea
Source: ClinicalTrials.gov NCT02576847 ↗
Enrolled (actual)
307
Serious AEs
2.3%
Results posted
Jul 2022
Primary outcomePrimary: Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events — 48 participants
◆ Published Evidence
Established
40citations · ~13 / year
Rational design of stapled antimicrobial peptides.
Summary
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
Linked Publications
-
Rational design of stapled antimicrobial peptides.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events |
48 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, male and nonpregnant female subjects, 18 years of age or older.
- A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
- Subjects with the presence of telangiectasia at Baseline
- Subjects with the presence of facial erythema associated with their rosacea at Baseline
Exclusion Criteria
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea
- Standard exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT02576847) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.