Incidence of squamous cell carcinoma and other skin neoplasia in subjects with actinic keratosis (sun spots) treated with ingenol disoxate gel or vehicle
Phase 1
- Conditions
- Actinic 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]
- Registration Number
- EUCTR2017-000228-85-GB
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 563
Inclusion Criteria
The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at Visit 11 of that trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 625
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
Exclusion Criteria
The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the incidence of squamous cell carcinoma after treatment with ingenol disoxate gel and vehicle gel;Secondary Objective: Not applicable;Primary end point(s): Time to first squamous cell carcinoma in the treatment area;<br> Timepoint(s) of evaluation of this end point: Month 6<br> Month 12<br> Month 18<br> Month 24<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Time to first squamous cell carcinoma or other skin neoplasia in the treatment area<br> Safety Evaluations: Adverse event frequency by MedDRA Preferred Term<br> ;<br> Timepoint(s) of evaluation of this end point: Month 6<br> Month 12<br> Month 18<br> Month 24<br>