Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

NCT01803477 | Completed Phase 1

• 1 other identifier: LP0085-1000
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Safety of 3 new vehicle formulations containing ingenol mebutate compared to Picato® 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. Relative skin reactions for comparison to Picato®.

  2 weeks

Secondary Outcomes (1)

• Evaluate treatment responses on AK of selected concentration of ingenol mebutate containing vehicle formulation from Part 1 compared to Picato® gel as assessed by reduction in the number of selected AK lesions 2 months after treatment

  2 months

Other Outcomes (1)

• Safety of the new ingenol mebutate vehicle formulation (ascertained in Part 1) compared to Picato® gel applied topically once daily for 2 consecutive days to 4 separate treatment areas containing actinic keratosis on the forearm

  8 weeks

Study Arms (4)

Picato® 0.05% gel

ACTIVE COMPARATOR

once daily for two consecutive days

Drug: once daily for two consecutive days (Picato)

ingenol mebutate vehicle formulation 1

EXPERIMENTAL

once daily for two consecutive days

Drug: once daily for two consecutive days (Picato)

ingenol mebutate vehicle formulation 2

EXPERIMENTAL

once daily for two consecutive days

Drug: once daily for two consecutive days (Picato)

ingenol mebutate vehicle formulation 3

EXPERIMENTAL

once daily for two consecutive days

Drug: once daily for two consecutive days (Picato)

Interventions

once daily for two consecutive days (Picato) DRUG

Also known as: Picato® 0.05% gel, escalating doses of ingenol mebutate vehicle formulation 1, escalating doses of ingenol mebutate vehicle formulation 2, escalating doses of ingenol mebutate vehicle formulation 3

Picato® 0.05% gel; ingenol mebutate vehicle formulation 1; ingenol mebutate vehicle formulation 2; ingenol mebutate vehicle formulation 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 the treatment visit
• presence of sunburn within the selected treatment areas
• use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
• previous enrolment in this clinical trial
• prior treatment with ingenol mebutate on the forearms
• use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit
• treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit
• treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit
• 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 or not being able to comply with the requirements of the protocol or provide consent

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Dermatology Department

Woolloongabba, Queensland, 4102, Australia

Location

Specialist Connect

Woolloongabba, Queensland, 4102, Australia

Location

Related Links

• Clinical Trials at LEO Pharma
• Therapeutic Goods Administration

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate; Gels

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Medical Expert

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)