Clinical trial NCT03546166: Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma
Official title: Open, Prospective, Single-center Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma
Keywords: basal cell carcinoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical
timeFrame: 3 months
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: determine the tolerance of the treatment: complete remission after 1 cycle
timeFrame: 3 months
measure: determine the tolerance of the treatment: complete remission after 2 cycle
timeFrame: 3 months and 6 months
measure: Evaluate the tumor response according to clinical criteria
timeFrame: 3 months
measure: Evaluate the tumor response according dermoscopic,
timeFrame: 3 months
measure: Evaluate the tumor response according Optical Coherence Tomography
timeFrame: 3 months
measure: Evaluate the tumor response according ultrasound
timeFrame: 3 months
measure: Evaluate the tumor response according histology
timeFrame: 3 months
measure: Evaluate the tumor response according to clinical criteria
timeFrame: 6 months
measure: Evaluate the tumor response according to dermoscopic
timeFrame: 6 months
measure: Evaluate the tumor response according to Optical Coherence Tomography
timeFrame: 6 months
measure: Evaluate the tumor response according to ultrasound
timeFrame: 6 months
measure: Evaluate the tumor response according histology
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Philippe BAHADORAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: McKay KM, Sambrano BL, Fox PS, Bassett RL, Chon S, Prieto VG. Thickness of superficial basal cell carcinoma (sBCC) predicts imiquimod efficacy: a proposal for a thickness-based definition of sBCC. Br J Dermatol. 2013 Sep;169(3):549-54. doi: 10.1111/bjd.12402.
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citation: Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.
citation: Ogbourne SM, Suhrbier A, Jones B, Cozzi SJ, Boyle GM, Morris M, McAlpine D, Johns J, Scott TM, Sutherland KP, Gardner JM, Le TT, Lenarczyk A, Aylward JH, Parsons PG. Antitumor activity of 3-ingenyl angelate: plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. 2004 Apr 15;64(8):2833-9. doi: 10.1158/0008-5472.can-03-2837.
citation: Rosen RH, Gupta AK, Tyring SK. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol. 2012 Mar;66(3):486-93. doi: 10.1016/j.jaad.2010.12.038. Epub 2011 Nov 4.
citation: Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.
citation: Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol. 2010 May;51(2):99-105. doi: 10.1111/j.1440-0960.2010.00626.x.