To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)

This study has been terminated.

(The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.)

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01033019

First received: December 15, 2009

Last updated: October 1, 2015

Last verified: October 2015

Results First Received: August 18, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator); Primary Purpose: Treatment
Condition:	Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Interventions:	Drug: LDE225 0.75% Drug: Vehicle

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-five participants were enrolled into the trial. However, one participant was excluded from the efficacy analysis. Therefore, the enrollment number differs from the number started below.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
LDE225 0.75%	Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
Vehicle	Participants topically applied matching placebo cream twice daily for 6 weeks.

Participant Flow: Overall Study

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
LDE225 0.75%	Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
Vehicle	Participants topically applied matching placebo cream twice daily for 6 weeks.
Total	Total of all reporting groups

Baseline Measures

	LDE225 0.75%	Vehicle	Total
Overall Participants Analyzed [Units: Participants]	16	8	24

Age [Units: Years] Mean (Standard Deviation)	63 (7.3)	63 (7.5)	63 (7.4)

Gender [Units: Participants]
Female	4	4	8
Male	12	4	16

Outcome Measures

1. Primary:

Clinical Evaluation of sBCCs Tumors [ Time Frame: Day 43 ]

Serious Adverse Events

Other Adverse Events

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information