Safety and Efficacy of Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days in Subjects With Actinic Keratosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01820260
First received: March 25, 2013
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel


Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate gel
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Part 1: Dose Limiting Toxicity based on LSRs up to and including Day 8 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Part 2: Complete clearance of AKs [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 2: Reduction in AK count [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]
  • Part 2: Partial clearance of AKs [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in the number of clinically visible AKs


Estimated Enrollment: 426
Study Start Date: April 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part 1: Ingenol mebutate gel
Open-label, dose escalation, 2 or 3 days treatment
Drug: Ingenol mebutate gel
Active Comparator: Part 2: Ingenol mebutate gel X dose for 3 days treatment
X dose for 3 days treatment
Drug: Ingenol mebutate gel
Active Comparator: Part 2: Ingenol mebutate gel X dose for 2 days treatment
X dose for 2 days treatment
Drug: Ingenol mebutate gel
Active Comparator: Part 2: Ingenol mebutate gel Y dose for 3 days treatment
Y dose for 3 days treatment
Drug: Ingenol mebutate gel
Active Comparator: Part 2: Ingenol mebutate gel Y dose for 2 days treatment
Y dose for 2 days treatment
Drug: Ingenol mebutate gel
Placebo Comparator: Part 2: Placebo for 3 days treatment
Placebo for 3 days treatment
Drug: placebo
Placebo Comparator: Part 2: Placebo for 2 days treatment
Placebo for 2 days treatment
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
    2. 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820260

Contacts
Contact: Birgitte Vestbjerg +45 44 94 58 88 birgitte.vestbjerg@leo-pharma.com

Locations
United States, Indiana
Laser & Skin Surgery Center of Inidana Recruiting
Carmel, Indiana, United States, 46032
Contact: C. William Hanke, MD         
Principal Investigator: C. William Hanke, MD         
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: C. William Hanke, MD Laser & Skin Surgery Center of Indiana
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01820260     History of Changes
Other Study ID Numbers: LP0105-1012
Study First Received: March 25, 2013
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014