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

Study Overview
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Brief Summary
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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

Official Title
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Open, Prospective, Single-center Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma

Conditions
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Carcinoma

Intervention / Treatment
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* Drug: Picato 0.05% Topical Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREATMENT<br> | Drug: Picato 0.05% Topical Gel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical |  | 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 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the tolerance of the treatment: complete remission after 1 cycle | For patients in complete remission after 1 cycle | 3 months | 
| determine the tolerance of the treatment: complete remission after 2 cycle | For patients in complete remission after 2 cycle | 3 months and 6 months | 
| Evaluate the tumor response according to clinical criteria |  | 3 months | 
| Evaluate the tumor response according dermoscopic, |  | 3 months | 
| Evaluate the tumor response according Optical Coherence Tomography |  | 3 months | 
| Evaluate the tumor response according ultrasound |  | 3 months | 
| Evaluate the tumor response according histology |  | 3 months | 
| Evaluate the tumor response according to clinical criteria | For patients in complete remission after 2 cycle | 6 months | 
| Evaluate the tumor response according to dermoscopic | For patients in complete remission after 2 cycle | 6 months | 
| Evaluate the tumor response according to Optical Coherence Tomography | For patients in complete remission after 2 cycle | 6 months | 
| Evaluate the tumor response according to ultrasound | For patients in complete remission after 2 cycle | 6 months | 
| Evaluate the tumor response according histology | For patients in complete remission after 2 cycle | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma