Phase 2
N=83
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT00617903 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) — -11.7; -10.8 Inflammatory lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azelaic acid (Drug); Vehicle foam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) |
-11.7; -10.8 | — |
| PRIMARY Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) |
46.3; 47.6 | — |
| PRIMARY Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) |
61.0; 47.6; 36.6; 45.2; 2.4; 7.1 | — |
| SECONDARY Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) |
9.1; 11.7; 6.8; 6.6; 4.3; 4.6 | — |
| SECONDARY Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 |
-7.5; -5.8; -9.9; -10.3; -12.4; -12.4 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) |
-49.5; -37.7; -62.7; -62.8; -75.1; -74.8 | — |
| SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
0; 2.6; 20.5; 10.5; 17.9; 21.1 | — |
| SECONDARY Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
-1.0; -0.7; -1.6; -1.3; -2.1; -1.9 | — |
| SECONDARY Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
5.1; 0; 30.8; 42.1; 51.3; 50.0 | — |
| SECONDARY Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
-0.3; -0.4; -0.6; -0.5; -0.8; -0.7 | — |
| SECONDARY Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 |
35.9; 42.1; 59.0; 52.6; 5.1; 5.3 | — |
| SECONDARY Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
0; 2.6; 35.9; 42.1; 64.1; 55.3 | — |
| SECONDARY Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
0.0; -0.1; -0.1; -0.3; -0.2; -0.3 | — |
| SECONDARY Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) |
5.1; 10.5; 92.3; 86.8; 2.6; 2.6 | — |
| SECONDARY Investigator's Rating of Overall Improvement at End of Study |
34.2; 40.0; 23.7; 17.5; 31.6; 27.5 | — |
| SECONDARY Patients' Rating of Overall Improvement at End of Study |
36.8; 27.5; 28.9; 22.5; 21.1; 22.5 | — |
| SECONDARY Patients' Opinion on Cosmetic Acceptability at End of Study |
42.1; 35.0; 36.8; 37.5; 10.5; 5.0 | — |
| SECONDARY Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 |
20.5; 13.2; 36.8; 35.1; 47.4; 54.3 | — |
| SECONDARY Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) |
38.5; 34.2; 55.3; 51.4; 73.7; 62.9 | — |
Summary
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.
Eligibility Criteria
Inclusion Criteria
- male and female patient at least 18 years of age
- signed informed consent
- Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
- Ability and willingness to accept and comply with treatment and required medical examinations
Exclusion Criteria
- Known non-responders to azelaic acid
- Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
- Presence of dermatoses that could interfere with the rosacea diagnosis
- Treatment with isotretinoin in the six months prior to randomization
- Treatment of the face with topical retinoids during the two weeks prior to randomization
- Treatment with oral antibiotics during the four weeks prior to randomization
- Treatment with topical antibiotics
- Treatment with systemic corticosteroids during 4 weeks prior to randomization
- Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
- Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
- Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
- Use of a sauna during 2 weeks prior to randomization and during the study
- Facial laser surgery for telangiectasia during 6 weeks prior to randomization
- Planned concurrent use of any treatment other than study medication that affects rosacea
- History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
- Participation in another clinical trial during the last 4 weeks
Data sourced from ClinicalTrials.gov (NCT00617903). 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.