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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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ingenol mebutate gel 0.05 %
Ingenol mebutate gel 0.015 %
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Ingenol mebutate gel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica Dermatologica dell'Università di Modena e Reggio Emilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ingenol mebutate gel 0.05 %

Ingenol mebutate gel 0.015 %

Arm Description

Outcomes

Primary Outcome Measures

Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area
Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area).

Secondary Outcome Measures

Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as "percentage of participants" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as "percentage of participatns" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Effectiveness Satisfaction Questionnaire for Medication (TSQM)
Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Side Effects TSQM
Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Global Satisfaction TSQM
Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Convenience TSQM
Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).

Full Information

First Posted
February 6, 2013
Last Updated
May 31, 2021
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01787383
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Ingenol mebutate gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ingenol mebutate gel 0.05 %
Arm Type
Active Comparator
Arm Title
Ingenol mebutate gel 0.015 %
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ingenol mebutate gel 0.05 %
Other Intervention Name(s)
Picato®
Intervention Description
Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
Intervention Type
Drug
Intervention Name(s)
Ingenol mebutate gel 0.015 %
Other Intervention Name(s)
Picato®
Intervention Description
Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially
Primary Outcome Measure Information:
Title
Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area
Description
Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area).
Time Frame
3 days after treatment of each selected treatment area
Secondary Outcome Measure Information:
Title
Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Description
Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as "percentage of participants" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Time Frame
8 weeks after treatment
Title
Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Description
Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as "percentage of participatns" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Time Frame
8 weeks after treatment
Title
Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Description
Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Time Frame
8 weeks after treatment
Title
Effectiveness Satisfaction Questionnaire for Medication (TSQM)
Description
Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Time Frame
8 weeks
Title
Side Effects TSQM
Description
Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Time Frame
8 weeks
Title
Global Satisfaction TSQM
Description
Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Time Frame
8 weeks
Title
Convenience TSQM
Description
Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, 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
Facility Information:
Facility Name
Clinica Dermatologica dell'Università di Modena e Reggio Emilia
City
Modena
ZIP/Postal Code
41124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26300464
Citation
Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24.
Results Reference
derived

Learn more about this trial

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

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