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Completed

NCT Number: NCT01926496

Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream. Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive a second treatment cycle with the same treatment if the first treatment does not clear all AKs. Subjects will be followed over a period of three year (36 months) after first treatment

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Key information

Conditions

Actinic Keratosis (AK) Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Angers - Service de Dermatologie, Angers, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed Informed Consent Form (ICF) prior to any trial-related procedures
  • Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
  • Subject at least 18 years of age
  • Female subjects must be of either:
  • Non-childbearing potential, or,
  • Childbearing potential, provided there is a confirmed negative urine pregnancy test
  • Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)

Exclusion criteria

  • Location of the selected treatment area:
  • on the periorbital skin
  • on the perioral skin/around the nostrils
  • within 5 cm of an incompletely healed wound
  • within 10 cm of a suspected BCC or SCC or other neoplasia
  • Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
  • History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
  • History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
  • Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment area within 2 years prior to Screening (Visit 1)
  • Organ transplant recipients
  • Immunosuppressed subjects (for example HIV patients)
  • Female subjects who are breastfeeding.
  • Subjects who are institutionalised by court order or by the local authority
  • In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)

Treatment and study plan

Ingenol mebutate gel, 0.015%

Drug

Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.

Other names: Picato®

Imiquimod Cream, 5%

Drug

Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs

Other names: Aldara®

Primary outcomes

  1. Incidence of SCC

    Time frame: 3 years

    Cumulative incidence of SCC after treatment with ingenol mebutate gel and imiquimod cream.> The primary response criterion is diagnosis of SCC (defined as invasive SCC i.e. excludes SCC in situ) in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC or censoring.

Secondary outcomes

  1. Incidence of SCC and Other Neoplasia

    Time frame: 3 years

    Cumulative incidence of SCC and other neoplasia after treatment with ingenol mebutate gel and imiquimod cream.> The secondary response criterion is diagnosis of SCC and other neoplasia in the treatment field across the 3-year trial period.> Kaplan-Meier estimate based on time to SCC and other neoplasia, or censoring.

  2. Number of Participants With Complete Clearance of AK Lesions After Last Treatment

    Time frame: 8-16 weeks

    To compare the complete clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)

  3. Number of Participants With Partial Clearance of AK Lesions

    Time frame: 8-16 weeks

    To compare the partial (at least 75%) clearance of AK lesions in the selected treatment area after the last treatment cycle (at Week 8 or 16)

  4. Number of Participants With Complete Clearance of AK Lesions at 12 Months

    Time frame: 1 year

    To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Phase 4 Trial Comparing the Cumulative Incidence of SCC After Treatment With Ingenol Mebutate and Imiquimod for Multiple Actinic Keratoses on Face and Scalp. A Multi-centre, Randomised, Two-arm, Open Label, Active-controlled, Parallel Group, 36-month Trial

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2013
Registry last updated
Mar 7, 2025

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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