Rosacea
Conditions
Brief summary
To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea
Interventions
DRUGAzelaic acid foam - Placebo
Sponsors
DPT Laboratories, Ltd.
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must sign an Institutional Review Board (IRB) approved written informed consent for this study. 2. Subjects must be at least 18 years of age. 3. Subjects must have a definite clinical diagnosis of moderate to facial papulopustular rosacea, 4. Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other 5. Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations. 6. Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.
Exclusion criteria
1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation. 2. Current or past ocular rosacea 3. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment 4. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in judgment of the Investigator, would put the subject at undue risk or might confound the study assessments 5. Currently using any product containing Azelaic Acid/or belonging to the same family as Azelaic Acid foam, 15%. 6. Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout the study. 7. History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, and/or any ingredient in the study medication. 8. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline). 9. Current use of anticoagulation therapy and use throughout the study. 10. Use of medicated make-up (including anti-aging make-up) throughout the study 11. Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators). 12. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics. 13. Use of medicated cleansers on the face throughout the study. 14. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements 15. Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study. 16. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits. 17. Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study. 18. Previous enrollment in this study or current enrollment in this study at another participating site. 19. Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study. 20. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change (Reduction) of Lesion Count From Day 1 | Day 84 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azelaic Acid Foam Azelaic acid foam | 224 |
| Finacea Foam Azelaic acid foam | 224 |
| Placebo Foam Azelaic acid foam - Placebo | 219 |
| Total | 667 |
Baseline characteristics
| Characteristic | Placebo Foam | Total | Azelaic Acid Foam | Finacea Foam |
|---|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 12.42 | 50.7 years STANDARD_DEVIATION 13.37 | 51.6 years STANDARD_DEVIATION 13.85 | 51.5 years STANDARD_DEVIATION 13.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants | 183 Participants | 60 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants | 484 Participants | 164 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 211 Participants | 647 Participants | 221 Participants | 215 Participants |
| Sex: Female, Male Female | 166 Participants | 497 Participants | 164 Participants | 167 Participants |
| Sex: Female, Male Male | 53 Participants | 170 Participants | 60 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 224 | 0 / 224 | 0 / 219 |
| other Total, other adverse events | 0 / 224 | 0 / 224 | 0 / 219 |
| serious Total, serious adverse events | 1 / 224 | 0 / 224 | 2 / 219 |
Outcome results
Primary
Percent Change (Reduction) of Lesion Count From Day 1
Time frame: Day 84
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Azelaic Acid Foam | Percent Change (Reduction) of Lesion Count From Day 1 | 61.14 percentage of lesion reduction | Standard Deviation 33.623 |
| Finacea Foam | Percent Change (Reduction) of Lesion Count From Day 1 | 57.27 percentage of lesion reduction | Standard Deviation 34.513 |
| Placebo Foam | Percent Change (Reduction) of Lesion Count From Day 1 | 49.43 percentage of lesion reduction | Standard Deviation 44.437 |
90% CI: [96.1, 115.5]Fieller's method