- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820260
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2 on the Chest in Subjects With Actinic Keratosis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Indiana
-
Carmel, Indiana, United States, 46032
- Laser & Skin Surgery Center of Inidana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be competent to understand the nature of the trial and provide informed consent
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest
- Subject at least 18 years of age
Female subjects must be of either:
- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy
- Female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion
Exclusion Criteria:
Location of the treatment area (full face, full balding scalp or chest)
- within 5 cm of an incompletely healed wound,
- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC
- Prior treatment with ingenol mebutate gel within the treatment area
Lesions in the treatment areas 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
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
- Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
- Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment
- Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment
- Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications
- Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
- Presence of acute sunburn within the treatment areas
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- Subjects previously assigned to treatment in Part 1 or rand
- Female subjects who are breastfeeding.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.005%
Open-label, dose escalation, 3 days treatment
|
|
ACTIVE_COMPARATOR: Part 2: Ingenol mebutate gel 0.018% for 3 days treatment
Randomized, 3 days treatment
|
|
ACTIVE_COMPARATOR: Part 2: Ingenol mebutate gel 0.018% for 2 days treatment
Randomized 2 days treatment
|
|
ACTIVE_COMPARATOR: Part 2: Ingenol mebutate gel 0.027% for 3 days treatment
Randomized 3 days treatment
|
|
ACTIVE_COMPARATOR: Part 2: Ingenol mebutate gel 0.027% for 2 days treatment
Randomized 2 days treatment
|
|
PLACEBO_COMPARATOR: Part 2: Placebo for 3 days treatment
Randomized 3 days treatment
|
|
PLACEBO_COMPARATOR: Part 2: Placebo for 2 days treatment
Randomized 2 days treatment
|
|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.008%
Open-label, dose escalation, 3 days treatment
|
|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.012%
Open-label, dose escalation, 3 days treatment
|
|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.027%
Open-label, dose escalation, 3 days treatment
|
|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.04%
Open-label, dose escalation, 3 days treatment
|
|
EXPERIMENTAL: Part 1B: Ingenol mebutate gel 0.06%
Open-label, dose escalation, 2 days treatment
|
|
EXPERIMENTAL: Part 1A: Ingenol mebutate gel 0.018%
Open-label, dose escalation, 3 days treatment
|
|
EXPERIMENTAL: Part 1B: Ingenol mebutate gel 0.04%
Open-label, dose escalation, 2 days treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: To Identify the Maximum Tolerated Dose (MTD) Levels After Once Daily Treatment for 2 or 3 Days
Time Frame: 8 days after initial treatment
|
Dose tolerability was measures looking at the composite score of Local Skin Responses (LSR). The MTD was defined as the highest dose level with less than 4 subjects out of 12 experiencing dose limiting toxicity (DLT). DLT was defined as one or more of the following three local skin LSRs:
The grading is a scale of 1 to 4 (highest grade). |
8 days after initial treatment
|
Part 2: Number of Subjects With Complete Clearance of AKs
Time Frame: 8 weeks
|
Number of subjects with complete clearance of Actinic Keratosis lesions (AKs) at week 8 after 2 or 3 consecutive days of treatment with ingenol mebutate gel on the full face, full balding scalp or approximately 250 cm² on the chest
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 2: Reduction in AK Count
Time Frame: From baseline to Week 8
|
Reduction in actinic keratosis lesion count from baseline to week 8 (percentage, adjusted for anatomical location and pooled site)
|
From baseline to Week 8
|
Part 2: Number of Subjects With Partial Clearance of AKs
Time Frame: Week 8
|
Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in the number of clinically visible AKs
|
Week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LP0105-1012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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