NCT01892137

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2013

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

February 24, 2025

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

June 23, 2013

Last Update Submit

February 21, 2025

Conditions

Actinic Keratosis

Keywords

Actinic KeratosisHistopathologyReflectance Confocal MicroscopyLocal Skin Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Complete clearance of AKs in the Selected Treatment Area

    8 weeks

Study Arms (1)

Open label active

OTHER
Drug: Ingenol mebutate gel 0.05%

Interventions

Ingenol mebutate gel 0.05%DRUG

Once daily for 2 consecutive days

Open label active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Southderm Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

Melanoma Institute Australia

North Sydney, New South Wales, 2060, Australia

Location

The Skin Centre

Benowa, Queensland, 4217, Australia

Location

South East Dermatology Centre

Carina Heights, Queensland, 4152, Australia

Location

St John of God Dermatology

Subiaco, Western Australia, 6008, Australia

Location

Burswood Dermatology

Victoria Park, Western Australia, 6100, Australia

Location

Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd

Augsburg, 86179, Germany

Location

Collegium Medicum Berlin GmbH

Berlin, 10117, Germany

Location

Medizinisches Zentrum Bonn Friedensplatz

Bonn, 42275, Germany

Location

Hautarztpraxis Prof. Dr. med. C. Termeer

Stuttgart, 70499, Germany

Location

Related Links

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Martina Ulrich

    Collegium Medicum Berlin GmbH, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2013

First Posted

July 4, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

February 24, 2025

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)DE(4)