Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT02748902
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2016-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Study of Efficacy and Safety of Ingenol Mebutate 0.05% Gel for Common Warts on the Hands.
Sponsor:
Neal D. Bhatia, MD
Organization:
Study Overview
Official Title:
An Open Label Exploratory Study Evaluating the Efficacy and Safety of Ingenol Mebutate 0.05% Gel for the Treatment of Verruca Vulgaris.
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if ingenol mebutate 0.05% gel is safe and effective in treating common warts on the hands.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: