E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10059313 |
E.1.2 | Term | Anogenital warts |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 safety of single treatment with Picato® 0.05% repeated up to 2 times with two weeks intervals in subjects with anogenital warts. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of a single treatment with Picato® 0.05% repeated up to 2 times with two weeks intervals in subjects with anogenital warts.
To evaluate the recurrence rate of anogenital warts after 12 weeks in subjects who were completely clear of anogenital warts during the treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or Female of 18 years or above
- Has a clinical diagnosis of external genital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:
a. In both sexes: perineal, and perianal areas
b. In men: penis shaft, scrotum, glans penis and foreskin
c. In women: on the vulva
- Subjects have a total wart areas of at least 10 mm2, but no more than 500 mm2
- Female subjects of childbearing potential must be confirmed not pregnant
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E.4 | Principal exclusion criteria |
- Subject has received any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
- Subject suffer from any of the following conditions:
a. Known human immunodeficiency virus (HIV) infection
b. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
c. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
d. Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
- Subjects that are organ transplant recipients
- Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to
enrollment
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence and severity of Local Skin Reactions (LSR) and treatment related adverse events |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From first treatment and until start of Follow up. |
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E.5.2 | Secondary end point(s) |
Incidence and severity of Adverse Events
Complete clearance of the anogenital warts after end of trial and by visits
Reduction in anogenital warts count from baseline to end of trial and by visits
Recurrence rate
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From first treatment and until Follow up completed |
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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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |