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

July 20, 2023 updated by: Centre Hospitalier Universitaire de Nice

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06000
        • University Hospital of Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TREATMENT
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Philippe BAHADORAN, MD, PhD, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Actual)

March 11, 2021

Study Completion (Actual)

March 11, 2022

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-PP-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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