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

NCT ID: NCT01787383

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-01-31

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

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ingenol mebutate gel 0.05 %

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel 0.05 %

Intervention Type: DRUG

Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially

Ingenol mebutate gel 0.015 %

Intervention Type: DRUG

Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Ingenol mebutate gel 0.015 %

Group Type: ACTIVE_COMPARATOR

Ingenol mebutate gel 0.05 %

Intervention Type: DRUG

Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially

Ingenol mebutate gel 0.015 %

Intervention Type: DRUG

Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Interventions

Ingenol mebutate gel 0.05 %

Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially

Intervention Type: DRUG

Ingenol mebutate gel 0.015 %

Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Intervention Type: DRUG

Other Intervention Names

Picato®; Picato®

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

Clinica Dermatologica dell'Università di Modena e Reggio Emilia

Modena, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 26300464 (View on PubMed)

Other Identifiers

2012-002863-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LP0041-64

Identifier Type: -

Identifier Source: org_study_id