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

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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

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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