Phase 3
N=961
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01555463 ↗Enrolled (actual)
961
Serious AEs
0.7%
Results posted
Jan 2015
Primary outcome: Primary: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) — 32.1; 23.4 Percentage of participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azelaic acid foam, 15% (BAY39-6251) (Drug); Vehicle foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jan 2014
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) |
32.1; 23.4 | <.001 sig |
| PRIMARY Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF) |
-13.2; -10.3 | <.001 sig |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF) |
-61.6; -50.8 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF) |
66.3; 54.4 | — |
| SECONDARY Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF) |
61.5; 51.3; 36.9; 46.2; 1.7; 2.5 | — |
| SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF) |
4.6; 4.4; 27.5; 19.0; 34.2; 31.0 | — |
| SECONDARY Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF) |
8.5; 10.8 | — |
| SECONDARY Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF) |
9.3; 8.4; 51.8; 41.8; 34.2; 43.1 | — |
| SECONDARY Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF) |
27.3; 22.6; 65.8; 69.7; 6.8; 7.7 | — |
| SECONDARY Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF) |
80.1; 78.7; 8.7; 10.5; 8.3; 7.7 | — |
| SECONDARY Participants' Global Assessment of Treatment Response at End of Treatment |
75; 42; 174; 151; 121; 128 | — |
| SECONDARY Participants' Global Assessment of Tolerability at End of Treatment |
167; 165; 128; 173; 112; 49 | — |
| SECONDARY Participants' Opinion on Cosmetic Acceptability at End of Treatment |
176; 124; 112; 142; 95; 99 | — |
| SECONDARY Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment |
186; 155; 143; 151; 67; 75 | — |
| SECONDARY Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score |
-6.8; -6.4 | — |
| SECONDARY Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score |
107; 82; 328; 349 | — |
| SECONDARY Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment |
0; 0 | — |
| SECONDARY Change From Baseline in Index Value at End of Treatment |
0.000; 0.000 | — |
Summary
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of papulopustular rosacea
- Free of any clinically significant disease, which could interfere with the study
- Male or female subject aged ≥ 18 years
- Willingness of subject to follow all study procedures
- Signed written informed consent before any study-related activities are carried out
Exclusion Criteria
- Subjects who are known to be non-responders to azelaic acid
- Presence of dermatoses that might interfere with rosacea diagnosis
- Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
- Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
- Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
- Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
- Known hypersensitivity to any ingredients of the investigational product formulation
- Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
- Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
Data sourced from ClinicalTrials.gov (NCT01555463). 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.