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

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)

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.

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Dermatology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Safety data to be collected via CRF entries of AEs/SAEs and photographs.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions	8 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Hans P Soyer, Dermatology Department, Brisbane Public Hospital

Publications and helpful links

Helpful Links

• Therapeutic Goods Administration
• LEO Pharma

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimated): October 10, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Skin Diseases; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: LP0084-68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO