Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands.
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|ClinicalTrials.gov Identifier: NCT02748902|
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Verruca Vulgaris Common Warts||Drug: ingenol mebutate 0.05% gel||Phase 1|
This is an open label exploratory study evaluating the efficacy and safety of ingenol mebutate 0.05% gel for the treatment of verruca vulgaris. The study will be conducted at one site with one investigator, all subjects will receive active drug. Prior to the application of the investigational product (IP) on Day 1, the individual warts will be pared down with a 15 blade up to obtain debridement of intact skin to maximize exposure and allow for effective penetration of therapy into the lesion.
Subjects can be screened for the study up to 45 days before Visit 1. During screening, the study requirements will be reviewed, written informed consent obtained, and eligibility confirmed. If applicable, qualified subjects can washout from prohibited medications or treatments prior to Visit 1 once they have been consented. These procedures may be combined with Visit 1.
There will be one treatment arm, all subjects receive active ingenol mebutate 0.05% gel once daily for two consecutive days to lesions. Each subject will be screened for inclusion. The treatment will be applied to the entire wart lesion(s) and 0.5 cm margin around the lesion(s). All treatments will be applied in the clinic. A minimum of two (2) and a maximum of five (5) warts will be treated. In addition, one of the two warts will be identified for treatment with occlusion with a bandage each day for 24 hours after each application.
The subjects will be evaluated at Day 1 and Day 2 when the consecutive applications of investigational product will be applied, then at Day 8, 29 and 57 to evaluate anticipated efficacy outcomes (lesion size, clearance, etc.) as well as assess for adverse events/SAEs. The wart that is identified for occlusion will be treated with investigational product and occluded for 24 hours after each application of IP. Subjects will be instructed to avoid excessive exposures to water or other potential contactants or irritants after application of the IP for the following 48 hours to avoid transfer of the IP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Exploratory Study Evaluating the Efficacy and Safety of Ingenol Mebutate 0.05% Gel for the Treatment of Verruca Vulgaris.|
|Actual Study Start Date :||April 27, 2016|
|Actual Primary Completion Date :||January 27, 2017|
|Actual Study Completion Date :||March 30, 2017|
Experimental: ingenol mebutate 0.05% gel
Single group, open label. All subjects will receive active product.
Drug: ingenol mebutate 0.05% gel
Ingenol mebutate 0.05% gel applied to a minimum of two and a maximum of five common warts on days 1 and 2.
Other Name: Picato®
- Efficacy assessed by verruca vulgaris lesion counts (total number of lesions present) [ Time Frame: Day 1 through Day 57 ]Total number of warts in the treatment area will be counted and assessed for clearance
- Safety assessed by number and severity of adverse events reported [ Time Frame: Day 1 through Day 57 ]All adverse events that occur during the study (from the time of informed consent) will be recorded.
- Safety assessed by application site reactions on a 5 point scale (0/clear - 4/severe) [ Time Frame: Day 1 through Day 57 ]Application site reactions defined as of erythema, flaking/scaling, crusting, swelling, erosion/ulceration and vesiculation/pustulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748902
|United States, California|
|Therapeutics Clinical Research|
|San Diego, California, United States, 92123|
|Principal Investigator:||Neal D Bhatia, MD||TCR Medical Corporation|