Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01703078
First received: October 5, 2012
Last updated: April 3, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.


Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol once daily for two consecutive days
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Exploratory Trial Evaluating Safety and Tolerability of Topical Administration of Different Concentrations of an Ingenol Derivative Compared to Ingenol Mebutate Gel 0.05% Applied on Two Consecutive Days to Four Separate 25cm2 Treatment Areas on the Forearms of Subjects With Actinic Keratosis (Field Therapy)

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Safety data to be collected via CRF entries of AEs/SAEs and photographs.


Secondary Outcome Measures:
  • Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions


Enrollment: 41
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ingenol mebutate gel 0.05%
once daily for two consecutive days
Drug: Ingenol once daily for two consecutive days
Experimental: Ingenol derivative concentration 1
once daily for two consecutive days
Drug: Ingenol once daily for two consecutive days
Experimental: Ingenol derivative concentration 2
once daily for two consecutive days
Drug: Ingenol once daily for two consecutive days
Experimental: Ingenol derivative concentration 3
once daily for two consecutive days
Drug: Ingenol once daily for two consecutive days

Detailed Description:

Various concentrations of new ingenol derivatives will be applied to AKs on the forearms. Reactions and safety will be compared to a US registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.

  Eligibility

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

Inclusion Criteria:

  • Must be male or female and at least 18 years of age.
  • Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
  • Ability to provide informed consent

Exclusion Criteria:

  • location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
  • undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
  • use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 2
  • use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 2 Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of Visit 2
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to visit 2
  • use of systemic retinoids
  • those who are currently participating in any other clinical trial
  • females who are pregnant or are breastfeeding
  • those known or suspected of not being able to comply with the requirements of the protocol or provide consent
  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: NCT01703078

Locations
Australia, Queensland
Dermatology Department
Woolloongabba, Queensland, Australia, 4102
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Hans P Soyer Dermatology Department, Brisbane Public Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01703078     History of Changes
Other Study ID Numbers: LP0084-68
Study First Received: October 5, 2012
Last Updated: April 3, 2013
Health Authority: Australia: National Health and Medical Research Council

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

ClinicalTrials.gov processed this record on October 02, 2014