Status:
COMPLETED
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
Lead Sponsor:
LEO Pharma
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after o...
Eligibility Criteria
Inclusion
- Subjects must be competent to understand the nature of the trial and provide informed consent
- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest
- Subject 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 potential1 must be willing to use effective contraception at trial entry and until completion
Exclusion
- Location of the treatment area (full face, full balding scalp or chest)
- 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 within the treatment area
- Lesions in the treatment areas that have:
- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions
- History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
- Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the 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
- Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment
- Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications
- Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
- Presence of acute sunburn within the treatment areas
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- Subjects previously assigned to treatment in Part 1 or rand
- Female subjects who are breastfeeding.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT01820260
Start Date
April 1 2013
End Date
August 1 2014
Last Update
March 13 2025
Active Locations (1)
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1
Laser & Skin Surgery Center of Inidana
Carmel, Indiana, United States, 46032