A Placebo controlled study to test DFD-04 Ointment 5% in patients with rosacea over 12-weeks

Phase 1

Conditions: papulopustular Rosacea (patients with inflammatory lesions of rosacea)
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2015-005486-23-DE

Lead Sponsor: Dr. Reddy's Laboratories, Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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. Male and female subjects aged 18 – 64 years.

4. Subjects, any gender or race (Fitzpatrick skin type I – III), must be in good general health as determined by the Investigator.

5. Subjects should have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 3.

6. Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over the face.

7. Subjects must have a CEA score of 2 – 3.

8. Subjects must have not more than 2 nodules.

9. Subjects must agree to only use the study products and to not use any other treatment for rosacea (prescription or OTC) or any other skin care or cosmetics product (make-up etc.) on the facial skin during the course of the study.

10. Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.

11. Females have a negative urine pregnancy test at the Screening and Baseline Visit. Test must have a sensitivity of at least 25 mIU/ml for hCG.

12. 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 % per year when used consistently and correctly.
Acceptable methods of birth control include:
• hormonal methods* (implants, injectables, combined oral contraceptives) or intrauterine device in use = 90 days prior to Baseline; or
• partner has had a vasectomy at least 90 days prior to Baseline; or
• sexual abstinence
o Note: Sexually inactive female subjects may be enrolled at the investigator’s discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study.
*Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline and continued on same method and dose throughout the duration of the study. If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline.

13. 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). Subjects are eligible at screening if:
Systolic BP =160 and =100
Diastolic BP =100 and =50
Pulse 50 – 100 bpm inclusive

14. Subject is physically able to apply study product to all affected areas.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).

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 CYP3A4 metabolised HMG-CoA reductase inhibitors, such as lovastatin, simvastatin and atorvastatin and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin. The Investigator should also exclude all drugs (listed in the Sporanox Label, please refer to Appendix 3) that are known to increase itraconazole concentrations in the blood or whose concentration is increased by itraconazole, based on the potential impact of such interactions on QT interval prolongation.

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 with known hypersensitivity to itraconazole or any component of the study products or against other kinds of azoles.

9. Subjects with values of >2.5 fold ULN in AST/GOT and or ALT/GPT and/or gGT and/or AP as well as an values >1.5 fold ULN in serum creatinine at screening, or other clinically significant abnormal laboratory test that, in the opinion of the investigator, would compromise the subject’s ability to participate in the trial.

10. Subjects positive for HIV-antibody, HBs-antigen and HCV-antibody-test at screening.

11. Subjects who are unable to comply with study requirements.

12. Subjects with other skin diseases that may confound the evaluation of rosacea.

13. History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.

14. 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

15. 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.

16. Subject institutionalized because of legal or regulatory order.

17. History of drug or alcohol abuse in the last year.