TerminatedPhase 2

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

Stopped: The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.

Australia, Austria25 participantsStarted 2009-12

Plain-language summary

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).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical Evaluation of sBCCs Tumors

Timeframe: Day 43

Trial details

NCT IDNCT01033019

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2015-08-18

View on ClinicalTrials.gov More Sporadic Superficial and Nodular Skin Basal Cell Carcinomas trials