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

NCT01703078 | Completed Phase 1

• 1 other identifier: LP0084-68
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  8 weeks

Study Arms (4)

Ingenol mebutate gel 0.05%

ACTIVE COMPARATOR

once daily for two consecutive days

Drug: Ingenol once daily for two consecutive days

Ingenol derivative concentration 1

EXPERIMENTAL

once daily for two consecutive days

Drug: Ingenol once daily for two consecutive days

Ingenol derivative concentration 2

EXPERIMENTAL

once daily for two consecutive days

Drug: Ingenol once daily for two consecutive days

Ingenol derivative concentration 3

EXPERIMENTAL

once daily for two consecutive days

Drug: Ingenol once daily for two consecutive days

Interventions

Ingenol once daily for two consecutive days DRUG

Ingenol derivative concentration 1; Ingenol derivative concentration 2; Ingenol derivative concentration 3; Ingenol mebutate gel 0.05%

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 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Dermatology Department

Woolloongabba, Queensland, 4102, Australia

Location

Related Links

• LEO Pharma
• Therapeutic Goods Administration

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans P Soyer

  Dermatology Department, Brisbane Public Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 24, 2025

Record last verified: 2013-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)