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

Phase 2

Completed

• Conditions: Carcinoma
• Interventions: Drug: Picato 0.05% Topical Gel

• Registration Number: NCT03546166
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-06
• Study Start: 2018-07-26
• Primary Completion: 2021-03-11
• Study Completion: 2022-03-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TREATMENT	Picato 0.05% Topical Gel	-

Primary Outcome Measures

Name	Time	Method
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
To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Nice; 🇫🇷 Nice, France