Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Actinic Keratosis Clinical Trial

Official title:

Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892137
• Other study ID #: LP0041-62
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2013
• Last updated: April 4, 2016
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• 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 on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception

• Ability to provide informed consent

• Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand

• AK should be confirmed by histopathology of one of the AK's prior to inclusion

Exclusion Criteria:

• location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma

• undergone Cosmetic or therapeutic procedures

• use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1

• use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.

• treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1

• treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1

• use of systemic retinoids

• those who are currently participating in any other interventional 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Ingenol mebutate gel 0.05%
Once daily for 2 consecutive days

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	South East Dermatology Centre	Carina Heights	Queensland
Australia	Southderm Pty Ltd	Kogarah	New South Wales
Australia	Melanoma Institute Australia	north Sydney	New South Wales
Australia	St John of God Dermatology	Subiaco	Western Australia
Australia	Burswood Dermatology	Victoria Park	Western Australia
Germany	Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd	Augsburg
Germany	Collegium Medicum Berlin GmbH	Berlin
Germany	Medizinisches Zentrum Bonn Friedensplatz	Bonn
Germany	Hautarztpraxis Prof. Dr. med. C. Termeer	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of AK	The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).	8 weeks	No
Secondary	Complete clearance of AKs in the Selected Treatment Area	Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK.	8 weeks	Yes

External Links

•   Clinical Trials at LEO Pharma
•   LEO Pharma
•   Therapeutic Goods Administration