A Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of IDP-109 Solution in the Treatment of Patients with Verrucae Vulgares
- Conditions
- Verrucae vulgaresMedDRA version: 12.1Level: LLTClassification code 10010115Term: Common warts
- Registration Number
- EUCTR2009-016302-16-DE
- Lead Sponsor
- Dow Pharmaceutical Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 76
All of the following criteria have to be met for inclusion of a patient in the study:
1. Male or female patients of any race, aged 18 years or older.
2. Verbal and written informed consent obtained from the patient. 3.Clinical
diagnosis of a total of 2 to 10 common warts on the dorsal sides of both hands,
with a maximum of 5 warts per hand, at the Baseline visit.
4. Individual wart area is calculated as the greatest diameter (mm) multiplied by the
perpendicular diameter (mm) at the Baseline visit. The total wart area should not
exceed 500 mm².
5. Target wart: largest wart present with an area of 4 mm2 to 100 mm2.
6. The patient is in good general health as determined by the investigator based on
the patient’s medical history and physical examination.
7. Female must have a negative urine pregnancy test at the Screening and the
Baseline visit, and must either be post-menopausal, 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
such as implants, injectables, combined oral contraceptives, some intra uterine
devices [IUDs], sexual abstinence or vasectomized partner.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients are to be excluded from the study when one or more of the following conditions are met:
1. Female who is pregnant, nursing an infant, or planning a pregnancy during the
study period.
2. The total area of all dorsal warts does exceed 500 mm² at the Baseline visit.
3. Presence of mosaic or flat warts of the hands, warts on the palms, or periungual
or subungual warts of the hands (plantar warts on the hands are allowed but
these will not be treated with study drug).
4. Presence of any known immunodeficiency condition (cancer, chemotherapy,
genetic, HIV, or transplant).
5. Any previous use of imiquimod for any condition.
6. Known allergy or hypersensitivity to imiquimod or any of the other ingredients in
the study drugs.
7. Use of any wart therapy by any modality (including destructive procedures and
topical medications) within 4 weeks prior to the Baseline visit.
8. Use of any topical corticosteroids for any skin condition on the hands within 4
weeks prior to the Baseline visit.
9. Use of any systemic corticosteroids within 4 weeks prior to the Baseline visit or
during the study (a stable regimen of inhaled or intranasal corticosteroids that is
not expected to change during the study is allowed).
10. Use of any immunosuppressive or immunomodulatory medications by any route
of administration within 4 weeks prior to the Baseline visit or during the study.
11. Patient has a known history of significant non-compliance with previous wart
therapies as determined by the Investigator.
12. Use of any investigational drug or device within 30 days or 5 half-lives,
whichever is longer, prior to the Screening visit, or concurrent participation in
another clinical trial with an investigational drug or device.
13. Symptoms of a clinically significant illness within 4 weeks prior to the screening
visit or during the study that may influence the outcome of the study.
14. In the opinion of the Investigator or physician performing the initial examination
the patient should not participate in the study, e.g. due to probable
noncompliance or inability to understand the study and give adequately informed
consent.
15. Patient is a dependent person, i.e. a relative/family member of the Investigator
and/or is a member of the Investigator’s staff.
16. Patient is institutionalized because of legal or regulatory order.
17. Evidence of drug or alcohol abuse.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method