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

Primary Purpose

Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Picato 0.05% Topical Gel
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring basal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TREATMENT

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the efficacy, in terms of complete remission, of 1 of a topical treatment with picato 0.05% gel topical
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

Secondary Outcome Measures

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

Full Information

First Posted
May 22, 2018
Last Updated
July 20, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT03546166
Brief Title
Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma
Acronym
PICABAS
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma
Keywords
basal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREATMENT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Picato 0.05% Topical Gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
determine the tolerance of the treatment: complete remission after 1 cycle
Description
For patients in complete remission after 1 cycle
Time Frame
3 months
Title
determine the tolerance of the treatment: complete remission after 2 cycle
Description
For patients in complete remission after 2 cycle
Time Frame
3 months and 6 months
Title
Evaluate the tumor response according to clinical criteria
Time Frame
3 months
Title
Evaluate the tumor response according dermoscopic,
Time Frame
3 months
Title
Evaluate the tumor response according Optical Coherence Tomography
Time Frame
3 months
Title
Evaluate the tumor response according ultrasound
Time Frame
3 months
Title
Evaluate the tumor response according histology
Time Frame
3 months
Title
Evaluate the tumor response according to clinical criteria
Description
For patients in complete remission after 2 cycle
Time Frame
6 months
Title
Evaluate the tumor response according to dermoscopic
Description
For patients in complete remission after 2 cycle
Time Frame
6 months
Title
Evaluate the tumor response according to Optical Coherence Tomography
Description
For patients in complete remission after 2 cycle
Time Frame
6 months
Title
Evaluate the tumor response according to ultrasound
Description
For patients in complete remission after 2 cycle
Time Frame
6 months
Title
Evaluate the tumor response according histology
Description
For patients in complete remission after 2 cycle
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe BAHADORAN, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21375515
Citation
Ramsay JR, Suhrbier A, Aylward JH, Ogbourne S, Cozzi SJ, Poulsen MG, Baumann KC, Welburn P, Redlich GL, Parsons PG. The sap from Euphorbia peplus is effective against human nonmelanoma skin cancers. Br J Dermatol. 2011 Mar;164(3):633-6. doi: 10.1111/j.1365-2133.2010.10184.x. Epub 2011 Jan 27.
Results Reference
background
PubMed Identifier
23627639
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.
Results Reference
background
PubMed Identifier
19183171
Citation
Mogensen M, Nurnberg BM, Forman JL, Thomsen JB, Thrane L, Jemec GB. In vivo thickness measurement of basal cell carcinoma and actinic keratosis with optical coherence tomography and 20-MHz ultrasound. Br J Dermatol. 2009 May;160(5):1026-33. doi: 10.1111/j.1365-2133.2008.09003.x. Epub 2009 Jan 12.
Results Reference
background
PubMed Identifier
26239203
Citation
Prieto-Granada C, Rodriguez-Waitkus P. Basal cell carcinoma: Epidemiology, clinical and histologic features, and basic science overview. Curr Probl Cancer. 2015 Jul-Aug;39(4):198-205. doi: 10.1016/j.currproblcancer.2015.07.004. Epub 2015 Jul 8. No abstract available.
Results Reference
result
PubMed Identifier
27932240
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.
Results Reference
result
PubMed Identifier
15087400
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.
Results Reference
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PubMed Identifier
22055282
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.
Results Reference
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PubMed Identifier
22417254
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.
Results Reference
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PubMed Identifier
20546215
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.
Results Reference
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Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma

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