Verrucae vulgares MedDRA version: 12.1 Level: LLT Classification code 10010115 Term: Common warts
Conditions
Interventions
Product Name: IDP-109 Topical Solution
Product Code: IDP-109
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Imiquimod
CAS Number: 99011-02-6
Concentration unit: % percent
Concentration t
Sponsors
Dow Pharmaceutical Sciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the safety and efficacy of once daily topical application of IDP-109 solution compared with vehicle solution in treating patients aged 18 years or older with verrucae vulgares (common warts) of the dorsal hands.;Secondary Objective: There is no discrimination in primary and secondary objectives in this study;Primary end point(s): The primary efficacy endpoint will be percent of patients with complete clearance of all Baseline warts at week 8 or end of treatment. | — |
Countries
Germany
Outcome results
None listed