A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
Condition: Rosacea
MeSH terms: Rosacea
Intervention: DFD-29 Extended Release Capsules (40 mg); DFD-29 Extended Release Capsules (20 mg); Oraycea® (doxycycline) Capsules; Placebo Capsules
Intervention description: Oral Treatment; Oral Treatment; Oral Treatment; Oral Treatment
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:
DFD-29 Extended Release Capsules (40 mg)
DFD-29 Extended Release Capsules (20 mg)
Doxycycline Modified Release Hard Capsules (40 mg)
Placebo Capsules
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment
      (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on
      inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.
    

Eligibility 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, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in
             good general health as determined by the Investigator.

          4. Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.

          5. Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and
             pustules) of rosacea over the face.

          6. Subjects must have not more than 2 nodules.

          7. Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA
             scale.

          8. Females must have a negative urine pregnancy test at the screening and baseline visit.

          9. 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 <1% up to 1 month after last dose.

         10. Subjects must be in good general health as determined by the investigator and
             supported by the medical history and normal or not clinically significant abnormal
             vital signs (blood pressure and pulse).

        Exclusion Criteria:

          1. Females who are pregnant or nursing or planning to become pregnant during the study.

          2. Male whose female partner is planning to conceive a child.

          3. Subjects who have been treated for rosacea within the 30 days prior to the Baseline
             Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).

          4. Subjects who have been treated with systemic retinoids within 6 months prior to the
             Baseline visit.

          5. Subjects who have participated in a trial involving any investigational product in the
             90 days prior to the Baseline Visit.

          6. Subjects with any disease or medical condition that would interfere with the study
             outcome or place the subject at undue risk.

          7. Subjects who use or have used systemic steroids within the 30 days prior to the
             Baseline Visit or any other immunosuppressive medication.

          8. Subjects who are on anti-coagulants or those who are likely to require anti-coagulants
             during the study period.

          9. History of drug or alcohol abuse in the last year.