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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-001474-27-DK |
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Date of registration:
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13/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomised, double-blinded parallel group study to compare efficacy and tolerability of topically applied Baceca and Tazarotene against placebo and Tazarotene in patients with basal cell carcinoma - N/A
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Scientific title:
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A randomised, double-blinded parallel group study to compare efficacy and tolerability of topically applied Baceca and Tazarotene against placebo and Tazarotene in patients with basal cell carcinoma - N/A |
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Date of first enrolment:
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07/07/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001474-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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:
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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skin cancer of the type of Basal Cell Carcinoma (BCC)
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Intervention(s)
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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: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)
Pharmaceutical Form: Gel
INN or Proposed INN: Tazarotene
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.1-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives will be to determine the tolerability and safety of repeated topical application in patients with BCC.
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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
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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).
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Secondary ID(s)
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Baceca-030-BCC
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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