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

Actinic Keratosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703078
• Other study ID #: LP0084-68
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2012
• Last updated: April 3, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Ingenol once daily for two consecutive days

Locations

Country	Name	City	State
Australia	Dermatology Department	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   LEO Pharma
•   Therapeutic Goods Administration