A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

This study is currently recruiting participants.
Verified December 2013 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01922050
First received: August 12, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Part 1:

To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations


Condition Intervention Phase
Actinic Keratosis
Drug: LEO 43204 Formulation 1
Drug: LEO 43204 Formulation 2
Drug: LEO 43204 Formulation 1 Dose X
Drug: LEO 43204 Formulation 1 Dose Y
Drug: LEO 43204 Formulation 2 Dose XX
Drug: LEO 43204 Formulation 2 Dose YY
Drug: Placebo Formulation 1
Drug: Placebo Formulation 2
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 Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) 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 Local Skin Responses (LSRs) up to and including Day 8 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Part 2: Percent reduction in actinic keratosis (AK) counts from baseline to Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 2: Complete clearance of AKs at week 8 [ 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 AK count


Estimated Enrollment: 588
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: LEO 43204 Formulation 1
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 1
Experimental: Part 1: LEO 43204 Formulation 2
Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 2
Experimental: Part 2: LEO 43204 Formulation 1 Dose X
Double-Blind, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 1 Dose X
Experimental: Part 2: LEO 43204 Formulation 1 Dose Y
Double-Blind, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 1 Dose Y
Experimental: Part 2: LEO 43204 Formulation 2 Dose XX
Double-Blind, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 2 Dose XX
Experimental: Part 2: LEO 43204 Formulation 2 Dose YY
Double-Blind, Once-Daily, 2-Day Treatment
Drug: LEO 43204 Formulation 2 Dose YY
Placebo Comparator: Part 2: Placebo Formulation 1
Double-Blind, Once-Daily, 2-Day Treatment
Drug: Placebo Formulation 1
Placebo Comparator: Part 2: Placebo Formulation 2
Double-Blind, Once-Daily, 2-Day Treatment
Drug: Placebo Formulation 2

  Eligibility

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

Inclusion Criteria:

  1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.
  2. Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
  3. Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
  4. Subject at least 18 years of age.
  5. Female subjects must be of either:

    1. Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,
    2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.
  6. Female subjects of childbearing potential must use effective contraception throughout the study.

Exclusion Criteria:

  1. Location of the treatment area within 5 cm (2 inches) of:

    1. an incompletely healed wound,
    2. a suspected basal or squamous cell carcinoma.
  2. Prior treatment with ingenol mebutate gel on the treatment area.
  3. Lesions in the treatment areas that have:

    1. atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
    2. recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
  4. 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, Rosacea), at the investigator's discretion.
  5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
  6. Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
  7. Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
  8. 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.
  9. Known sensitivity or allergy to any of the ingredients in the LEO 43204.
  10. Presence of acute sunburn within the treatment areas.
  11. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
  12. Subjects previously randomised in the trial (Part 1 or 2).
  13. Female subjects who are breastfeeding.
  14. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922050

Contacts
Contact: Aruna Sharma 905-747-2354 aruna.sharma@leo-pharma.com

Locations
United States, Florida
Recruiting
Ormond Beach, Florida, United States, 32174
Principal Investigator: James Solomon, MD, PhD         
United States, New Jersey
Recruiting
Verona, New Jersey, United States, 07044
Principal Investigator: Robert Nossa, MD         
United States, Texas
Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Elizabeth Tichy, MD         
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Gary Goldenberg, MD Mount Sinai School of Medicine, Dermatology Faculty
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01922050     History of Changes
Other Study ID Numbers: LP0084-1013
Study First Received: August 12, 2013
Last Updated: December 10, 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 April 17, 2014