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NCT Number: NCT03546166

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

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Key information

Conditions

Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Picato 0.05% Topical Gel

Drug

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 outcomes

  1. 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

  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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 3 months

    For patients in complete remission after 1 cycle

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

    Time frame: 3 months and 6 months

    For patients in complete remission after 2 cycle

  3. Evaluate the tumor response according to clinical criteria

    Time frame: 3 months

  4. Evaluate the tumor response according dermoscopic,

    Time frame: 3 months

  5. Evaluate the tumor response according Optical Coherence Tomography

    Time frame: 3 months

  6. Evaluate the tumor response according ultrasound

    Time frame: 3 months

  7. Evaluate the tumor response according histology

    Time frame: 3 months

  8. Evaluate the tumor response according to clinical criteria

    Time frame: 6 months

    For patients in complete remission after 2 cycle

  9. Evaluate the tumor response according to dermoscopic

    Time frame: 6 months

    For patients in complete remission after 2 cycle

  10. Evaluate the tumor response according to Optical Coherence Tomography

    Time frame: 6 months

    For patients in complete remission after 2 cycle

  11. Evaluate the tumor response according to ultrasound

    Time frame: 6 months

    For patients in complete remission after 2 cycle

  12. Evaluate the tumor response according histology

    Time frame: 6 months

    For patients in complete remission after 2 cycle

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: PICABAS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 6, 2018
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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