E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030338 |
E.1.2 | Term | Onychomycosis |
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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 |
The primary objective of the study is to evaluate the efficacy of SCH 900340 5% solution relative to its vehicle in the treatment of onychomycosis of the toenail, as determined by various efficacy measurements. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are: To assess the safety and tolerability of SCH 900340 5% solution; and, To explore patient-reported outcomes of SCH 900340 5% solution. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be 18 to 75 years of age (both inclusive) at Screening, and can be of either sex and of any race. 2. Subjects must have distal subungual onychomycosis due to dermatophytes that: (a) involves at least 25% of the total area (ie, the area circumscribed by the distal groove and the proximal and lateral nail folds) of the target great toenail according to the investigator's visual inspection after properly trimming the nail (b) does not involve the proximal 25% of the nail (no nail matrix involvement) (c) has been mycologically confirmed at Screening (central laboratory KOH and central laboratory culture positive for dermatophytes). 3. Subjects must have the target great toenail capable of growing, as assessed by the investigator during Screening. 4. Subjects must have a thickness of the distal target great toenail plate of ≤3 mm as measured at Screening by the investigator or a subinvestigator. 5. Subjects must be able to apply the study drug to their toenails. 6. Subjects must agree to use no other products (including nail polish) applied to the toenails during the study. 7. Subjects' clinical laboratory tests (hematology and blood chemistries) must be clinically acceptable to the investigator. 8. Women of child-bearing potential who are currently sexually active must agree to use a medically accepted method of contraception prior to randomization, while receiving protocol-specified medication, and for 4 weeks after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). 9. Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. |
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E.4 | Principal exclusion criteria |
1. Subjects with anatomic abnormalities of the target great toenail, including but not limited to genetic nail disorders, pigmentary disorders, onychogryposis, trauma to the nail, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments. 2. Subjects with one or more of the following conditions on the target great toenail: a. proximal subungual onychomycosis, b. white superficial onychomycosis, dermatophytoma, exclusively lateral disease, or yellow/brown spikes, c. any non-dermatophyte infection (eg, Scopulariopsis spp and Scytialidium spp), d. any other condition (eg, past history of trauma) that in the opinion of the Investigator could interfere with the ability of the investigator to assess the subject's response to the study medication. 3. Subjects with a current or past history of psoriasis and/or lichen planus. 4. Subjects with clinically significant nonfasting serum glucose levels at Screening will have a repeat fasting test including glucose and hemoglobin A1C (Hgb A1C) during the Screening phase. Subjects with Hgb A1C ≥8% will be excluded from the study. 5. Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses. 6. Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic therapy. 7. Subjects with a history of chronic mucocutaneous candidiasis. 8. Subjects with a history of any known immunodeficiency. 9. Subjects with a history of treatment failure (defined as no recognized increase in clear nail growth) after completion of >=3 months of any oral antifungal administered according to label. 10. Subjects who have received treatment for any type of cancer within the last 6 months, except non melanoma skin cancer. 11. Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments: Prohibited Medications (Washout Period) -Systemic antifungal treatments (24 weeks prior to Screening), -Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (12 weeks prior to Screening), -Oral or intramuscular corticosteroid and oral or intramuscular immunosuppressive agents (4 weeks prior to Screening), -Topical anti-inflammatory, topical corticosteroid, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1), -Investigational drugs (4 weeks prior to Screening), -Topical antifungal agents for the treatment of tinea pedis (1 week prior to Screening). 12. Subjects with a history of street drug or alcohol abuse within 6 months prior to Screening, as determined by the investigator. 13. Women who are breast-feeding, pregnant, or intend to become pregnant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is related to the primary objective of the study. The primary efficacy endpoint of the study is the complete cure rate of the target great toenail at Week 48. |
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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 | No |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 19 |
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 | 19 |
E.8.9.2 | In all countries concerned by the trial days | 0 |