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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area

Outcome Description:

Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential)

Outcome Time Frame:

3 days after treatment of each selected treatment area

Safety Issue:

No

Authority:

Italy: Agenzia Italiana del Farmaco

Study ID:

LP0041-64

NCT ID:

NCT01787383

Start Date:

February 2013

Completion Date:

December 2013

Related Keywords:

  • Actinic Keratosis
  • Actinic Keratosis
  • Ingenol mebutate gel
  • Keratosis
  • Keratosis, Actinic

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