NCT02446223

Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%

A Pilot Prospective Clinical Trial to Evaluate the Efficacy and Safety of Large-Scale, Field-Directed Topical Therapy of Actinic Keratosis of the Chest With Ingenol Mebutate 0.015%

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%

Detailed description

This will be an open-label study to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% used in topical therapy of actinic keratosis on the chest. Subjects that present with 4 or more actinic keratosis in one continuous 100cm2 area of the chest and meet all inclusion/exclusion criteria will be enrolled into this study. Treatment with the investigational product (IP) will be applied for three continuous days. The investigator will guide application of the IP in-office at Day 0 and the subject will be instructed to self-administer the IP at Days 1 and 2. Follow-up visits will be scheduled at Days 1, 3, 10, 17, 24 and 59. Prior to treatment and at each visit, the investigator will assess the subject's treatment area for lesion counts and at follow up visits 4, 5, 6 and 7 evaluation of clearance. Pre-treatment photography will also be collected at baseline and at each follow up visit.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Inggenol Mebutate 0.015%

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-05-18
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: United States