Open, prospective, single-center study evaluating the efficacy and safety of 0.05% ingénol mebutate (Picato® 500) in the treatment of basal cell carcinomaStudy PICABAS

Phase 1

• Conditions: Patients with one or more basal cell carcinoma superficial, or nodular, trunk or limb; MedDRA version: 20.0Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004608-22-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-27
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients of both sexes of more than 18 years old
• Patients having one or several superficial CBC, or nodulaire, of the trunk or the members (scalp and face excluded), confirmed histologically by biopsy
• primitive CBC, of main line between 1 and 4 cms
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• CBC of the scalp or the face
• CBC reoffend, sclérodermiforme, infiltrating, métatypique
• CBC of diameter > 4cm
• CBC situated unless 10 cms of another CBC included in the protocol
• allergic Patient in at the MI or in an excipient of the finished product (example alcohol isopropylique) as indicated on the note of the medicine.
• Patient treaty by immunosuppresseurs, immunomodulateurs, agents cytotoxiques by systematic way or local corticoids applied to the zone of the CBC, during 4 weeks preceding the visit of selection
·• cosmetic or therapeutic Treatment or any procedure which could interfere with the evaluation of the handled zone
• Presence of a dermatological affection susceptible to interfere with the treatment(processing) or its evaluation (eczema, psoriasis, etc.)
• Presence of néoplasie associated evolutionary other than a Melanoma of Dubreuil In situ (except squamous-cell carcinoma, carcinoma épidermoïde cutaneous, carcinoma of the in situ neck of the womb and the in situ mammary carcinoma)
• Use of the MI, the cryotherapy, the imiquimod, Dynamic Phototherapy, or treatment by radiotherapy in the zone of treatment and 5 cms all around in 6 months preceding the first visit
• pregnant or breast-feeding Woman (an urinary pregnancy test will be realized)
• Infection known by the HIV
• transplanted Patient
• Participation or less than 30 days in a medicinal clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified