A Study to Assess the Efficacy, Safety and Tolerability of DFD-04
Condition: Rosacea
MeSH terms: Rosacea
Intervention: DFD-04 Ointment; Placebo Ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this exploratory study is to assess the efficacy, safety and tolerability of
      DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.
    

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. Subjects must be willing to provide authorization to use protected health information.

          3. Subjects, any gender or race, must be in good general health as determined by the
             Investigator

          4. Subjects must have a clinical diagnosis of papulopustular rosacea, Investigator's
             Global Assessment (IGA) grade 2 - 3.

          5. Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over
             the face.

          6. Subjects must have a Clinician's Erythema Assessment (CEA) score of 2 - 3.

          7. Subjects must have no more than 2 nodules.

          8. Subjects must agree to only use the study products and to not use any other treatment
             for rosacea (prescription or over the counter) or any other skin care or cosmetics
             product (make-up etc.) on the facial skin of the treatment area during the course of
             the study.

          9. Subjects must be free of any systemic or dermatologic disorder, which in the opinion
             of the Investigator, will interfere with the study results.

         10. Females have a negative urine pregnancy test at the Screening and Baseline Visit.

         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 reliable method
             of contraception with a failure rate of less than 1 percent per year when used
             consistently and correctly.

         12. Subject 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).

         13. Subject is physically able to apply study product to all affected areas.

        Exclusion Criteria:

          1. Females who are pregnant or nursing or planning to become pregnant during the study.

          2. Subjects who have been treated for rosacea within the 30 days prior to the Baseline
             Visit.

          3. Subjects who have been treated with systemic retinoids within 6 months prior to the
             Baseline visit.

          4. Subjects who have participated in a trial involving any investigational product in the
             30 days prior to the Baseline Visit.

          5. Subjects with any disease or medical condition that would interfere with the study or
             place the subject at undue risk especially cardiovascular diseases, reduced lung
             function (including asthma), renal dysfunction or liver dysfunction.

          6. Subjects who have been treated within 30 days prior to baseline visit with
             methadone,disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as
             dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine
             (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam,
             felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin,
             ticagrelor, terfenadine, astemizole, mizolastine, eletriptan, as well as lovastatin,
             simvastatin and atorvastatin and, in subjects with varying degrees of renal or hepatic
             impairment, colchicine, fesoterodine, telithromycin and solifenacin.

          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 positive for human immunodeficiency virus (HIV), hepatitis B and hepatitis
             C-test at screening.

          9. Subjects who are unable to comply with study requirements.

         10. Subjects with other skin diseases that may confound the evaluation of rosacea.

         11. History of organ transplant requiring immunosuppression, HIV, or other immune
             compromised state.

         12. Subject who in the opinion of the investigator or physician performing the initial
             examination the subject should not participate in the trial, e.g. due to probable
             noncompliance or inability to understand the trial and give adequately informed
             consent

         13. Subject with close affiliation with the investigator (e.g. a close relative) or
             persons working at the respective trial sites or subject who are an employee of
             sponsor.

         14. Subject institutionalized because of legal or regulatory order.

         15. History of drug or alcohol abuse in the last year.