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A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01787383
First received: February 6, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel


Condition Intervention Phase
Actinic Keratosis
Drug: Ingenol mebutate gel 0.05 %
Drug: Ingenol mebutate gel 0.015 %
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area [ Time Frame: 3 days after treatment of each selected treatment area ] [ Designated as safety issue: No ]
    Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential)


Secondary Outcome Measures:
  • Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
    Complete clearance of Actinic Keratosis lesions (AKs) in each separate treatment area

  • Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
    Partial clearance of Actinic Keratosis lesions (AKs) in each separate treatment area defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment

  • Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
    Percent reduction in number of Actinic Keratosis lesions (AKs) in each separate treatment area


Enrollment: 200
Study Start Date: February 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ingenol mebutate gel 0.05 % Drug: Ingenol mebutate gel 0.05 %
Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
Other Name: Picato®
Drug: Ingenol mebutate gel 0.015 %
Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially
Other Name: Picato®
Active Comparator: Ingenol mebutate gel 0.015 % Drug: Ingenol mebutate gel 0.05 %
Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
Other Name: Picato®
Drug: Ingenol mebutate gel 0.015 %
Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially
Other Name: Picato®

  Eligibility

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

Inclusion Criteria:

  • Subjects must provide informed consent
  • Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp
  • Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities
  • Subjects at least 18 years of age
  • Female subjects must be of either:

    1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
    2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
  • Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Exclusion Criteria:

  • Location of the selected treatment areas:

    • on the periorbital skin
    • within 5 cm of an incompletely healed wound
    • within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
  • Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
  • Lesions in the selected treatment areas that have:

    • atypical clinical appearance (and/or,
    • recalcitrant disease
  • History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication
  • Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas
  • Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment.
  • Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application.
  • Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
  • Presence of sunburn within the selected treatment areas
  • Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial
  • Subjects previously randomised in the trial
  • Female subjects who are breastfeeding
  • In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol

Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1:

  • Cosmetic or therapeutic procedures within 2 cm of the selected treatment areas
  • Use of topical keratolytic therapeutic products within 2 cm of the selected treatment areas
  • Use of topical medicated creams, ointments, lotions, gels, foams or sprays including topical steroids : within 2 cm of the selected treatment areas; artificial tanners: within 5 cm of the selected treatment areas

Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 1:

  • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers
  • Treatment with systemic medications that suppress the immune system
  • Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)

Prohibited Therapies and/or Medications within 8 weeks prior to Visit 1:

- Treatment with 5-fluorouracil (5-FU), imiquimod, topical diclofenac sodium, or photodynamic therapy within 2 cm of the selected treatment areas.

Prohibited Therapies and/or Medications within 6 months prior to Visit 1:

- Use of systemic retinoids or biologic/monoclonal antibody therapies

  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: NCT01787383

Locations
Italy
Clinica Dermatologica dell'Università di Modena e Reggio Emilia
Modena, Italy, 41124
Sponsors and Collaborators
LEO Pharma
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01787383     History of Changes
Other Study ID Numbers: LP0041-64, 2012-002863-88
Study First Received: February 6, 2013
Last Updated: February 25, 2014
Health Authority: Italy: Agenzia Italiana del Farmaco
Spain: Agencia Espagnola de Medicamentos y Productos Sanitarios

Keywords provided by LEO Pharma:
Actinic Keratosis
Ingenol mebutate gel

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014