| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Inflammatory Lesions of papulopustular Rosacea |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10076537 |
| E.1.2 | Term | Papulopustular rosacea |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
To evaluate the efficacy of oral DFD-29 (minocycline 20 mg and 40 mg capsules) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks.
To evaluate the safety and tolerability of oral DFD-29 (minocycline HCL 40mg capsules) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks.
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| E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of oral DFD-29 ( 20 mg ) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks
• the efficacy of the two dosage strengths of oral DFD-29 (20 mg and 40 mg ) in comparison to Oraycea® (doxycycline 40 mg capsules) in the treatment of inflammatory lesions of rosacea for 16 weeks.
• the safety and tolerability of oral DFD-29 ( 20 mg ) in comparison to placebo in the treatment of inflammatory lesions of rosacea for 16 weeks.
•the safety and tolerability of the two dosage strengths of oral DFD-29 ( 20 mg and 40 mg ) in comparison to Oraycea® (doxycycline 40 mg capsules) in the treatment of inflammatory lesions of rosacea for 16 weeks.
•the efficacy of oral DFD-29 (40 mg ) in comparison to oral DFD-29 (20 mg ) in the treatment of inflammatory lesions of rosacea for 16 weeks.
•the safety and tolerability of oral DFD-29 ( 40 mg ) in comparison to DFD-29 (20 mg ) in the treatment of inflammatory lesions of rosacea for 16 weeks
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. Subjects must agree to only use the study products and to not use any other treatment for rosacea (prescription or Over The Counter (OTC)) 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, and especially free of any skin diseases (for example peri-oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne vulgaris) that may confound the evaluation of rosacea.
10. Females must have a negative urine pregnancy test at the Screening and Baseline Visit. Sensitivity of such a test should at least be 25 mIU/mL or lower for 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 <1% up to 1 month after last dose. Contraception methods with low user dependency should preferably be used, in particular when contraception is introduced as a result of participation in this clinical study.
‘Highly effective’ methods of birth control include:
• combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation*:
o oral
o intravaginal
o transdermal
• progesterone-only hormonal contraception associated with inhibition of ovulation*:
o oral
o injectable
o implantable†
• intra-uterine device (IUD) †
• intra-uterine hormone releasing system (IUS) †
• bilateral tubular occlusion†
• vasectomy of sexual partner that was performed at least 90 days prior to Baseline, and has been medically assessed as successful†
• sexual abstinence
o Note: Sexually inactive female subjects may be enrolled at the investigator’s discretion provided that they are counseled to refrain from heterosexual intercourse for the duration of the study and for one month after the last dose, 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. Female subjects on low dose oral contraceptives (containing ≤35 µg of ethinyl estradiol or equivalent dose of other estrogens) must use a second form of contraceptive during the study.
† Contraception methods that are considered to have low user dependency.
12. 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). Subjects are eligible at screening if:
a. Systolic BP ≤140 and ≥90
b. Diastolic BP ≤100 and ≥50
c. Pulse 50 – 100 bpm inclusive
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| E.4 | Principal 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. Subjects who have used methoxyflurane or other nephrotoxic drugs (as judged by the investigator) within the past 30 days.
10. Subjects with known hypersensitivity to minocycline or doxycycline or any component of the study products or against other kinds of tetracyclines.
11. Subjects with clinically significant abnormal laboratory test that, in the opinion of the investigator, would compromise the subject’s safety or ability to participate in the trial.
12. Subjects who are unable to comply with study requirements.
13. History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
14. Subjects who in the opinion of the investigator or physician performing the initial examination, should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent.
15. Subjects with close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial sites or subjects who are an employee of the sponsor.
16. Subjects institutionalized because of legal or regulatory order.
17. History of drug or alcohol abuse in the last year.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
•Proportion of subjects with IGA (modified scale without erythema) ‘treatment success’ – Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
•Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
•Proportion of subjects with at least a 2 grade reduction in IGA (modified scale without erythema) score from baseline to week 16
•Median change in total RosaQol score from Baseline to Week 16.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
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