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
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
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014