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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Sporadic Superficial and Nodular Skin Basal Cell Carcinomas

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Clinical evaluation of sBCCs tumors (complete response, partial response, no response / worsening)

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

CLDE225B2204

NCT ID:

NCT01033019

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
  • Basal cell carcinomas,
  • sporadic,
  • superficial and nodular,
  • skin
  • Carcinoma
  • Carcinoma, Basal Cell

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