Rosacea MedDRA version: 20.0 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: DFD-29
Pharmaceutical Form: Capsule
INN or Proposed INN: MINOCYCLINE HYDROCHLORIDE
CAS Number: 13614-98-7
Current Sponsor code: DFD-29
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Dr. Reddy's Laboratories Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Male and female subjects aged 18 years and above. 3. Subjects must be in good general health as determined by the investigator and supported by the medical history. 4. Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline. 5. Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline. 6. Subjects must have not more than 2 nodules or cysts at Baseline. 7. Subjects must agree to only use the study medication and to not use any other treatment for rosacea (prescription or over-the-counter [OTC]) during the course of the study. 8. Subjects must be willing to minimize or not significantly change external factors that might trigger rosacea flare-ups (such as spicy food, thermally hot foods, soups and drinks, hot environments, prolonged sun exposure, strong winds, alcoholic beverages, etc.) throughout the study. 9. Subjects must be free of any systemic or dermatologic disorder that, in the opinion of the investigator, will interfere with the study results, and especially free of any skin diseasesthat may confound the evaluation of rosacea. 10. Females of childbearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. Sensitivity of such a test should at least be 25 mIU/mL or lower for human chorionic gonadotropin (hCG). 11. Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or nursing or planning to become pregnant during the study. 2. Male subjects whose female partner is planning to conceive a child. 3. Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial. 4. History of organ transplant requiring immunosuppression, HIV, or other immune compromised state. 5. History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness. 6. Use of any firbidden treatment more recently than the indicated washout period prior to Baseline (Visit 2/Day 1). 7. Need or intent to use any treatment listed in the protocol as prohibited during the current study. 8. History of allergy or known sensitivity to minocycline, doxycycline, other tetracyclines, or any component of the study medication. 9. Consumption of excessive alcohol, abuse of drugs, or a condition that could compromise and/or have drug or alcohol-addiction requiring treatment in the past 12 months. 10. Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. 11. Use of any investigational drugs within 90 days prior to Baseline 12. Participation in any other clinical study within 90 days prior to Baseline. 13. Previous participation in this study. 14. Subjects institutionalized due to legal or regulatory disorder 15. Employees of the research center or Investigator. 16. Family members of employees of the research center of Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the safety, efficacy, and tolerability of oral DFD-29 (Minocycline HCl), 40 mg compared to placebo in the treatment of papulopustular rosacea for 16 weeks;Secondary Objective: Evaluation of the safety, efficacy, and tolerability of DFD-29 compared to Doxycycline capsules 40 mg (an authorized generic of Oracea® in the United States) in the treatment of papulopustular rosacea for 16 weeks;Primary end point(s): Safety/Tolerability. - Change from Baseline to each scheduled time point up to End of Study (EOS) for vital signs, physical examination and clinical laboratory tests. - Treatment-emergent AEs up to EOS. - Treatment-emergent AEs leading to premature discontinuation of study drug - Treatment-emergent SAEs up to EOS Primary Efficacy: Co-Primary Efficacy Endpoints 1. Proportion of Subjects with IGA 'treatment success' grade 0 or 1 at week 16 with at least 2 grade reduction from Baseline to Week 16 compared to Placebo 2. Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1. Percentage Change in Total inflammatory lesion count (sum of papules, pustules, and nodules) from Baseline to Week 16 in the DFD-29 group compared to Placebo 2. Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. 3. Total inflammatory lesion count reduction from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. 4. Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo. 5. Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to Placebo. ;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Germany, United States
Contacts
Public ContactMallikarjuna Rao
Dr. Reddy's Laboratories Ltd
Outcome results
None listed