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CarcinomaPhase 2PICABASNCT03546166

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

A Phase 2 study testing Picato 0.05% Topical Gel in people with Carcinoma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma
What is being tested?
Picato 0.05% Topical Gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteFrance
Study dates
26 Jul 2018to 11 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • University Hospital of Nice

    Nice, 06000

Other trials in France

About this study

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

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

Conditions
Carcinoma
Being tested
Picato 0.05% Topical Gel
Keywords
basal cell carcinoma
Medical subject headings
Carcinoma, Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Picato 0.05% Topical GelDrug

    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.

Study groups in NCT03546166
Study groupRoleWhat they receive
TREATMENTExperimentalNot described
Receives: Drug: Picato 0.05% Topical Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

  2. 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

    Measured: 6 months

Secondary outcomes (12)

  1. determine the tolerance of the treatment: complete remission after 1 cycle

    For patients in complete remission after 1 cycle

    Measured: 3 months

  2. determine the tolerance of the treatment: complete remission after 2 cycle

    For patients in complete remission after 2 cycle

    Measured: 3 months and 6 months

  3. Evaluate the tumor response according to clinical criteria

    Measured: 3 months

  4. Evaluate the tumor response according dermoscopic,

    Measured: 3 months

  5. Evaluate the tumor response according Optical Coherence Tomography

    Measured: 3 months

  6. Evaluate the tumor response according ultrasound

    Measured: 3 months

  7. Evaluate the tumor response according histology

    Measured: 3 months

  8. Evaluate the tumor response according to clinical criteria

    For patients in complete remission after 2 cycle

    Measured: 6 months

  9. Evaluate the tumor response according to dermoscopic

    For patients in complete remission after 2 cycle

    Measured: 6 months

  10. Evaluate the tumor response according to Optical Coherence Tomography

    For patients in complete remission after 2 cycle

    Measured: 6 months

  11. Evaluate the tumor response according to ultrasound

    For patients in complete remission after 2 cycle

    Measured: 6 months

  12. Evaluate the tumor response according histology

    For patients in complete remission after 2 cycle

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start26 Jul 2018
  3. Primary completion11 Mar 2021
  4. Study completion11 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03546166
Sponsor's protocol ID
17-PP-21
Acronym
PICABAS
Status last verified
Jul 2023
First submitted
22 May 2018
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21375515

  • 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.

    PubMed 23627639

  • 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.

    PubMed 19183171

  • 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.

    PubMed 26239203

  • 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.

    PubMed 27932240

  • 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.

    PubMed 15087400

  • 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.

    PubMed 22055282

  • 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.

    PubMed 22417254

  • 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.

    PubMed 20546215

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Picato 0.05% Topical Gel in people with Carcinoma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03546166, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

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