Phase 2
N=401
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01025635 ↗Enrolled (actual)
401
Serious AEs
1.0%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) — 43.4; 32.5 Percentage of participants — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azelaic acid foam 15% (Drug); Vehicle foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) |
43.4; 32.5 | 0.017 sig |
| PRIMARY Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) |
-13.4; -9.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) |
-62.5; -47.8 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) |
69.2; 57.6 | — |
Summary
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
- Free of any clinically significant disease which could interfere with the study
- Willingness to follow all study procedures
- Male or female patient at least 18 years of age
Exclusion Criteria
- Subjects known to be non-responders to azelaic acid
- Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
- Ocular rosacea, phymatous rosacea
- Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
- Facial laser surgery in the 6 weeks prior to the study
- Topical or systemic use of prescription or non-prescription medications to treat rosacea
- Use of any agent other than the investigational drugs to treat rosacea during the study
- Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
- Known hypersensitivity to any ingredients of the investigational product formulation
- Alcohol or drug abuse
- Incapability of giving fully informed consent
- Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
- Participation in another clinical research study within the last 4 weeks before randomization in this study
Data sourced from ClinicalTrials.gov (NCT01025635). 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.