Trial Outcomes & Findings for Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015% (NCT NCT02446223)

Last Updated: 2019-09-06

Results Overview

The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

Day 59

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Active Inggenol Mebutate Inggenol Mebutate 0.015%
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=21 Participants Inggenol Mebutate 0.015%
Age, Categorical <=18 years	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=21 Participants
Age, Continuous	59.0 years STANDARD_DEVIATION 7.2 • n=21 Participants
Sex: Female, Male Female	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=21 Participants
Region of Enrollment United States	21 participants n=21 Participants
Lesion Count	11.3 Lesions STANDARD_DEVIATION 5.2 • n=21 Participants

PRIMARY outcome

Timeframe: Day 59

Outcome measures

Outcome measures
Measure	Active n=20 Participants Inggenol Mebutate 0.015%
Change in Lesion Count From Baseline to Day 59	2.7 Leasion Count Standard Deviation 0.6

Adverse Events

Active

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active n=21 participants at risk Inggenol Mebutate 0.015%
Skin and subcutaneous tissue disorders Erythema	28.6% 6/21 • Number of events 6

Additional Information

Clinical Research Coordinator

Cosmetic Laser Dermatology/West Dermatology Research

Phone: 858 657 1004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place