skin cancer of the type of Basal Cell Carcinoma (BCC)
Conditions
Interventions
Product Name: Baceca
Pharmaceutical Form: Gel
INN or Proposed INN: valproic acid
Other descriptive name: 2-propyl-pentanoic acid
Concentration unit: % (W/W) percent weight/weight
Concentration type: e
Sponsors
TopoTarget A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Criteria for Inclusion: 1. men and women aged 18 years and older 2. informed consent signed by the patient Patients with at least one BCC tumor can be included if the lesion meets the following criteria: 3. macroscopically (clinically) consistent with BCC 4. histologically confirmed diagnosis of BCC for the tumor lesion to be treated. 5. The tumor has to be at least 0,5 cm2, but not more than 4cm2. 6. exhibits clearly defined margins 7. easily identifiable and treatable 8. located anywhere on the body except on eye lids, lips, nose, mucosa or in anogenital region 9. A tumor biopsy within the last 6 months is usable according to protocol. The BCC must not have been treated with a drug or a non-drug treatment which could have a direct influence on the tumor. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. females of child bearing potential 2. presence or history of disorders commonly accepted as contraindications for the treatment with 2-PPA like jaundice or any serious hepatic, pancreatic, renal or haematologic function disorders or any significant cardiovascular, haematologic, neurologic, malignant, psychiatric, respiratory, metabolic or hypertensive disease. 3. presence of disorders commonly accepted as contraindications for topical retinoid treatment like inflammation of the skin following perioral dermatitis, acute eczema, rosacea 4. patients with a known allergy or history of hypersensitivity to any of the substances in the study medication 5. patients with other skin disorders that might interfere with BCC evaluation. 6. any concomitant BCC treatment or any BCC treatment within the last 30 days including any topical treatment , photodynamic therapy or radiation or systemic therapy or any treatment to any BCC lesion (different to target lesion) that may influence the course of BCC. 7. any concomitant therapy like curettage, electrodesiccation, cryotherapy or surgical excision of the BCC lesion. 8. any orally administered concomitant treatment or any treatment within the last 30 days with drugs like corticosteroids (except a low dose steroid treatment below 20mg/day, if the treatment is constant before, during and after the study), retinoids, COX inhibitors, immunomodulators or immunsuppressiva, any experimental drug or with systemic chemotherapeutics within the last 6 months 9. recent history of alcohol abuse or any other substance abuse 10. patients unable to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be to determine the efficacy of repeated topical applications of Tazarotene together with Baceca or placebo in patients with basal cell carcinomas (BCC).;Secondary Objective: The secondary objectives will be to determine the tolerability and safety of repeated topical application in patients with BCC.;Primary end point(s): The primary composite endpoint for assessment of efficacy will be: the complete remission of the treated lesion compared to baseline assessed on the basis of the histological examination of the selected target tumor after 8 or 16 weeks, respectively | — |
Countries
Denmark
Outcome results
None listed