NCT01998984

Brief Summary

This is a randomised, double-blind, parallel groups, vehicle controlled, 8-week phase 2 trial. The objective is to evaluate efficacy of ingenol mebutate gel 0.06 % after once daily treatment for 2, 3 or 4 consecutive days compared to vehicle gel

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

December 7, 2018

Completed
Last Updated

March 10, 2025

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 21, 2013

Results QC Date

June 19, 2018

Last Update Submit

February 21, 2025

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)

    Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in number of AKs. The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset.

    At Week 8

Secondary Outcomes (2)

  • Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)

    At Week 8

  • Percentage of Participants With Partial Clearance of AKs

    At Week 8

Study Arms (4)

2 days placebo and 2 days drug

EXPERIMENTAL

Placebo and drug

Drug: ingenol mebutateOther: Placebo

1 day placebo and 3 days drug

EXPERIMENTAL

Placebo and drug

Drug: ingenol mebutateOther: Placebo

4 days placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

4 days drug

EXPERIMENTAL

Drug

Drug: ingenol mebutate

Interventions

ingenol mebutateDRUG
1 day placebo and 3 days drug2 days placebo and 2 days drug4 days drug
PlaceboOTHER
1 day placebo and 3 days drug2 days placebo and 2 days drug4 days placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with 5 to 20 clinically typical, visible and discrete AKs within a contiguous area of approximately 250 cm² sun-damaged skin on either trunk (except chest), or extremities

You may not qualify if:

  • Location of the treatment area (trunk (except chest) or extremities)
  • within 5 cm of an incompletely healed wound,
  • within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • Prior treatment with ingenol mebutate within the selected treatment area
  • Lesions in the treatment area that have:
  • atypical clinical appearance (e.g., hypertrophic,hyperkeratotic or cutaneous horns) and/or,
  • recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Island Skin Cancer and Dermatologic Surgery

Smithtown, New York, United States

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Clinical Trial Disclosure Manager
Organization
LEO Pharma A/S
disclosure@leo-pharma.com
+45 4494 5888

Study Officials

  • Daniel M Siegel, MD, MS

    Lond Island Skin Cancer and Dermatologic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 3, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 10, 2025

Results First Posted

December 7, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)