Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01033019
Registration number
NCT01033019
Ethics application status
Date submitted
15/12/2009
Date registered
16/12/2009
Date last updated
30/10/2015
Titles & IDs
Public title
To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)
Query!
Scientific title
Double-blind, Randomized, Vehicle-controlled Proof of Concept Study on the Efficacy, Safety, Local Tolerability, PK and Pharmacodynamics of Multiple Topical Administrations of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Query!
Secondary ID [1]
0
0
2009-013665-26
Query!
Secondary ID [2]
0
0
CLDE225B2204
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Non melanoma skin cancer
Query!
Cancer
0
0
0
0
Query!
Kidney
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - LDE225 0.75%
Treatment: Drugs - Vehicle
Experimental: LDE225 0.75% - Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
Placebo Comparator: Vehicle - Participants topically applied matching placebo cream twice daily for 6 weeks.
Treatment: Drugs: LDE225 0.75%
0.75% cream
Treatment: Drugs: Vehicle
matching placebo cream to 0.75% LDE225 cream
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Clinical Evaluation of sBCCs Tumors
Query!
Assessment method [1]
0
0
The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).
Query!
Timepoint [1]
0
0
Day 43
Query!
Eligibility
Key inclusion criteria
- Patients with one histologically confirmed superficial and nodular basal cell
carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm,
frontal trunk, posterior trunk, upper legs)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previous treatment of the sBCC that are selected for treatment.
- Any systemic treatment which is known to affect BCCs esp. cytostatic treatments,
retinoids and photodynamic treatments.
- Dark-skinned persons whose skin color prevents readily assessment of skin reactions
Other protocol defined Incl./Excl. criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
25
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Benowa
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Graz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Wien
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC
(sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a
treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post
treatment biopsies, as safety visit one week after final study drug administration (Day 50),
a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01033019
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01033019
Download to PDF