Sporadic Superficial and Nodular Skin Basal Cell Carcinomas Clinical Trial
Official 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
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).
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | February 2011 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Benowa | Queensland |
| Australia | Novartis Investigative Site | Woolloongabba | Queensland |
| Austria | Novartis Investigative Site | Graz | |
| Austria | Novartis Investigative Site | Wien |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Australia, Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical Evaluation of sBCCs Tumors | 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). | Day 43 | No |