Status:
COMPLETED
Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
Lead Sponsor:
Korea University
Collaborating Sponsors:
LEO Pharma
Chonnam National University Hospital
Conditions:
Actinic Keratosis
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
This study evaluate the efficacy and safety of ingenol mebutate gel 0.015% on face and scalp \& 0.05% on trunk and extremities in Korean patient with actinic keratosis.
Detailed Description
The mechanism of action of ingenol mebutate for actinic keratosis(AK) treatment involves a rapid induction of necrosis followed by neutrophil-mediated, antibody-dependent cellular cytotoxicity (ADCC) ...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 19 years
- Histopathologically diagnosed AK patients with at least 1 macroscopic and discrete lesion within a contiguous 25 cm2 (e.g. 5 cm x 5 cm) of treatment area
- The treatment area including the lesion must be accessible to apply the investigational product. However, the lesions on lips, mucosa, outer ear (concha) and those around eyes are excluded.
- Subjects who signed the written informed consent prior to perform any study-related procedures or assessments, including photographs of their treatment area for documentation and efficacy assessment.
Exclusion
- Hypersensitivity to any components of the investigational product
- History or evidence of skin conditions that could interfere with evaluation of the investigational product(e.g., eczema, unstable psoriasis, xeroderma pigmentosa, inflammatory or infectious disease around the selected treatment area)
- Unhealed wound within 5 cm, or basal cell carcinoma or squamous cell carcinoma within 10 cm from the selected treatment area.
- Subjects who received or expected to receive any of the following pharmacotherapy and non-pharmacotherapy or procedures during the treatment and follow-up period
- Subjects who have following disorder or abnormal laboratory result
- Pregnant, lactating, and childbearing potential women who are unwilling to practice effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and abstinence.
- Subjects who previously underwent another clinical trial within 30 days or 5-times the half-life of previous investigational product prior to baseline (the longer period of time must be considered).
- Other conditions by investigator's discretion to be inappropriate for this clinical study.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02716714
Start Date
April 1 2015
End Date
June 1 2016
Last Update
April 18 2018
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea, 15355