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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas

Treatments: Drug: LDE225 0.75%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033019

2009-013665-26

EudraCT 2009-013665-26

CLDE225B2204

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

LDE225 0.75%

Experimental group

Description:

Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.

Treatment:

Drug: LDE225 0.75%

Vehicle

Placebo Comparator group

Description:

Participants topically applied matching placebo cream twice daily for 6 weeks.

Treatment:

Drug: Vehicle