Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2012-003112-31-DE
EUCTR2012-003112-31-DE
Active, not recruiting
Phase 1

Risk of Squamous Cell Carcinoma on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% - Not applicable

EO Pharma A/S0 sites480 target enrollmentMay 13, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsPicato 150 micrograms/gram gelAldara 5% cream

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
EO Pharma A/S
Enrollment
480
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 13, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
EO Pharma A/S

Eligibility Criteria

Inclusion Criteria

  • •1\.Signed Informed Consent Form (ICF) prior to any trial\-related procedures
  • •2\.Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
  • •3\.Subject at least 18 years of age
  • •4\.Female subjects must be of either:
  • •a.Non\-childbearing potential, or,
  • •b.Childbearing potential, provided there is a confirmed negative urine pregnancy test
  • •5\.Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index \< 1%)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\.Location of the selected treatment area:
  • •on the periorbital skin
  • •on the perioral skin/around the nostrils
  • •within 5 cm of an incompletely healed wound
  • •within 10 cm of a suspected BCC or SCC or other neoplasia
  • •2\.Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
  • •3\.History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
  • •4\.History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
  • •5\.Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1\)
  • •6\.Organ transplant recipients

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Risk of Skin Cancer on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
EUCTR2012-003112-31-FREO Pharma A/S480
Active, not recruiting
Not Applicable
Risk of Skin Cancer on Skin Areas Treated with Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
EUCTR2012-003112-31-GBEO Pharma A/S480
Completed
Not Applicable
Metastases of cutaneous squamous cell carcinoma in organ transplant recipients - The *SCOPE-ITSCC metastases study*Skin cancersquamous cell carcinoma10040900
NL-OMON39568eids Universitair Medisch Centrum300
Active, not recruiting
Phase 1
Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis (sun spots) treated with ingenol disoxate gel or vehicleActinic KeratosisMedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
EUCTR2017-000228-85-GBEO Pharma A/S563
Active, not recruiting
Phase 1
Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis (sun spots) treated with ingenol disoxate gel or vehicleActinic KeratosisMedDRA version: 20.0Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
EUCTR2017-000228-85-DEEO Pharma A/S850