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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by LEO Pharma
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01926496
First received: August 19, 2013
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Actinic Keratosis (AK)
Drug: Ingenol Mebutate Gel, 0.015%
Drug: Imiquimod Cream, 5%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%. 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

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Incidence of SCC [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    To compare the 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.



Secondary Outcome Measures:
  • Incidence of neoplasia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To compare the cumulative incidence of neoplasia and the short-term and 12-month efficacy of ingenol mebutate gel with imiquimod cream.


Estimated Enrollment: 480
Study Start Date: September 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ingenol Mebutate
Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8
Drug: Ingenol Mebutate Gel, 0.015%
Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
Other Name: Picato®
Active Comparator: Imiquimod
Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8
Drug: Imiquimod Cream, 5%
Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Other Name: Aldara®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form (ICF) prior to any trial-related procedures
  2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp.
  3. Subject at least 18 years of age
  4. Female subjects must be of either:

    1. Non-childbearing potential, or,
    2. Childbearing potential, provided there is a confirmed negative urine pregnancy test
  5. Female subjects of childbearing potential must be willing to use highly effective methods of contraception (Pearl index < 1%)

Exclusion Criteria:

  1. 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
  2. Selected treatment area lesions that have atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horn).
  3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment area.
  4. 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
  5. 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)
  6. Organ transplant recipients
  7. Immunosuppressed subjects (for example HIV patients)
  8. Female subjects who are breastfeeding.
  9. Subjects who are institutionalised by court order or by the local authority
  10. 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926496

Contacts
Contact: Maj Britt Larsen, ICTM +4572262437 ext 2437 maj.larsen@leo-pharma.com

  Show 46 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Rolf- Markus Szeimies, Professor, Dr. med. Klinik für Dermatologie und Allergologie
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01926496     History of Changes
Other Study ID Numbers: LP0041-63, 2012-003112-31
Study First Received: August 19, 2013
Last Updated: November 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on October 19, 2014