Phase 4
Completed N=77
Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis
Source: ClinicalTrials.gov NCT02716714 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Apr 2018
Primary outcomePrimary: CC Rate of AK Lesions in the Selected Treatment Area — 49; 8; 15; 1 Participants
◆ Published Evidence
Highly cited
402citations · ~13 / year
Sunlight and sunburn in human skin cancer: p53, apoptosis, and tumor promotion.
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.
Linked Publications (5)
-
Sunlight and sunburn in human skin cancer: p53, apoptosis, and tumor promotion.
-
Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study.
-
Actinic keratoses.
-
Actinic keratosis: a clinical and epidemiological revision.
-
Actinic keratosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CC Rate of AK Lesions in the Selected Treatment Area |
49; 8; 15; 1 | — |
| SECONDARY Percentage Change of the Number of AK Lesions in the Selected Treatment Area |
-80.08; -88.89 | — |
| SECONDARY Sustained CC Rate in CC Group |
42; 6; 5; 1 | — |
| SECONDARY Recurrence Rate in CC Group |
5; 2; 42; 5 | — |
| SECONDARY Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group |
-88.65; -85.71 | — |
| SECONDARY Change From Baseline in Quality of Life (Skindex-29) |
20.57; 27.22; 21.21; 12.50; 15.28; 12.78 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) |
57.62; 61.11; 62.67; 70.37; 84.48; 91.67 | — |
| SECONDARY Cosmetic Outcomes Assessment (COA) |
16; 3; 33; 4; 5; 1 | — |
| SECONDARY Time to Relapse in CC Group |
NA; 203 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02716714) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.