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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 2

Conditions: Carcinoma

Treatments: Drug: Picato 0.05% Topical Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT03546166

17-PP-21

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

TREATMENT

Experimental group

Treatment:

Drug: Picato 0.05% Topical Gel