Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma

Centre Hospitalier Universitaire de Nice24 enrolled

Overview

Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma

Interventions

Picato 0.05% Topical Gel

apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days. In case of treatment failure after 3 months, apply again on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years * Histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis) Exclusion Criteria: * Basal cell carcinomas of the scalp * Basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic * Allergic patient to treatment products * Patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the CBC area during the 4 weeks prior to the screening visit

Locations (1)

University Hospital of Nice

Nice, France

Outcomes

Primary Outcomes

To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical

Time frame: 3 months

To evaluate the efficacy, in terms of complete remission, of 2 cycles (for patients who did not respond to the first cycle) of a topical treatment with picato 0.05% gel topical

Time frame: 6 months

Secondary Outcomes

determine the tolerance of the treatment: complete remission after 1 cycle

For patients in complete remission after 1 cycle

Time frame: 3 months

determine the tolerance of the treatment: complete remission after 2 cycle

For patients in complete remission after 2 cycle

Time frame: 3 months and 6 months

Evaluate the tumor response according to clinical criteria

Time frame: 3 months

Evaluate the tumor response according dermoscopic,

Time frame: 3 months

Evaluate the tumor response according Optical Coherence Tomography

Time frame: 3 months

Evaluate the tumor response according ultrasound

Time frame: 3 months

Evaluate the tumor response according histology

Time frame: 3 months

Evaluate the tumor response according to clinical criteria

For patients in complete remission after 2 cycle

Time frame: 6 months

Evaluate the tumor response according to dermoscopic

For patients in complete remission after 2 cycle

Time frame: 6 months

Evaluate the tumor response according to Optical Coherence Tomography

For patients in complete remission after 2 cycle

Time frame: 6 months

Evaluate the tumor response according to ultrasound

For patients in complete remission after 2 cycle

Time frame: 6 months

Evaluate the tumor response according histology

For patients in complete remission after 2 cycle

Time frame: 6 months

Data from ClinicalTrials.gov

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