Carcinoma
Conditions
Keywords
basal cell carcinoma
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
Interventions
DRUGPicato 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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 to dermoscopic | 6 months | For patients in complete remission after 2 cycle |
| Evaluate the tumor response according to Optical Coherence Tomography | 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 |
| Evaluate the tumor response according histology | 3 months | — |
| determine the tolerance of the treatment: complete remission after 2 cycle | 3 months and 6 months | For patients in complete remission after 2 cycle |
Countries
France
Outcome results
None listed