Oral Polypodium Leucotomos and Ingenol Mebutate gel 0.05% or Colchicine cream 0.5% in the treatment of Solar Queratoses
- Conditions
- Actinic keratosisSkin field CancerizationSquamous cell CarcinomaL57.0
- Registration Number
- RBR-5q5dg8
- Lead Sponsor
- Faculdade de Medicina - Unesp Botucatu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Sign the Term of Free and Informed Consent;
• Age above 18 years of both sexes;
• Present at least three and at most ten lesions clinically compatible with actinic keratosis in each forearm, bilaterally.
Injuries less than three or greater than ten in each forearm;
Selected treatment area that has atypical clinical appearance or other extensive dermatoses on the forearms;
Current and prior clinical diagnosis or evidence of any medical condition that exposes the patient to increased risks, interferes with the safety or efficacy of the proposed treatment;
To show hypersensitivity or allergy to any of the studied sub-substances;
Patients on any systemic or topical immunosuppressive substance, oral retinoid, in addition to other local treatments (eg corticosteroids, anti-inflammatories, retinoids);
Immunocompromised individuals;
Coagulation disorders;
Suspected or confirmed pregnancy;
Women of childbearing potential who do not use contraceptive methods;
Women in the breastfeeding phase.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete clearance rate of the actinic keratoses in the T60, with reduction difference of more than 10% between the groups, done through clinical counts of the AAS, before the beginning and 60 days after the beginning of the treatment.
- Secondary Outcome Measures
Name Time Method