Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis
This study has been completed.
Sponsor:
LEO Pharma
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
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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
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 May 19, 2013