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About
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.
Full description
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject is at least 18 years of age
Subject has a clinical diagnosis of common warts
Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
The Target Wart has a Physician Wart Assessment (PWA) ≥2
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
Subject is non-pregnant and non-lactating
Subject is in good general health and free of any known disease state or physical condition which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
Subject is willing and able to follow all study instructions and to attend all study visits
Subject is able to comprehend and willing to sign an Informed Consent Form.
Exclusion criteria
Subject has clinically atypical warts on the trunk or extremities
Subject is immune compromised (due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
Subject has a history of Human Immunodeficiency Virus (HIV) infection
Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to enrollment
Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
Subject has a history of sensitivity to any of the ingredients in the study medications
Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
Primary purpose
Allocation
Interventional model
Masking
98 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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