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Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT01998984
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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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

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: ingenol mebutate Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 days placebo and 2 days drug
Placebo and drug
 Drug: ingenol mebutate
Other: Placebo
Experimental: 1 day placebo and 3 days drug
Placebo and drug
 Drug: ingenol mebutate
Other: Placebo
Placebo Comparator: 4 days placebo
Placebo
 Other: Placebo
Experimental: 4 days drug
Drug
 Drug: ingenol mebutate


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) [ Time Frame: At Week 8 ]

    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.



Secondary Outcome Measures :
  1. Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation) [ Time Frame: At Week 8 ]

    The number of clinically visible AK lesions identified in the treatment area was to be recorded at Visit 1(≤14 days prior to Day 1).

    The analysis was based on 1000 imputations of actinic keratosis lesion count at Week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline actinic keratosis lesion count as offset. The table shows the adjusted percentage reduction from baseline.

    Values for the Ingenol 4 days arm were calculated separately based on observed cases. On the basis of the data monitoring committee's recommendation the 4-day active treatment group was closed, and this arm was excluded from statistical models and comparisons in the secondary efficacy analyses.


  2. Percentage of Participants With Partial Clearance of AKs [ Time Frame: At Week 8 ]

    Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in number of AKs, was analysed in the same way as the primary response criterion.

    The percent reduction at Week 8 from baseline was analyzed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values).

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01998984


Locations
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United States, New York
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, United States
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Daniel M Siegel, MD, MS Lond Island Skin Cancer and Dermatologic Surgery
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01998984    
Other Study ID Numbers: LP0105-1020
First Posted: December 3, 2013    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms