Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
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|ClinicalTrials.gov Identifier: NCT02242747|
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.
Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs.
Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: ingenol mebutate Drug: 5% 5-FU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Tolerability and Safety of 0.015% Ingenol Mebutate Gel Compared to 5% 5-fluorouracil Cream for the Treatment of Facial Actinic Keratosis: a Prospective Randomized Trial|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
Patients assigned to ingenol mebutate gel received an application a day for three consecutive days in a pre-determined area
Drug: ingenol mebutate
an application a day for three consecutive days in a pre-determined area
Other Name: Picato
Patients assigned to 5% 5-FU received two applications a day for four weeks in a pre-determined area
Drug: 5% 5-FU
two applications a day for four weeks in a pre-determined area
- Area under the LSR (local skin reactions)-Time Curve (AUC 0-43 days) [ Time Frame: Baseline and on day 43 ]Primary endpoint was to compare the total local skin reaction grading scale (LSR) and the area under the curve (AUC) with respect to duration of effects, using a generalized linear model, assuming a logarithmic link function. Age, Fitzpatrick skin type and site of the treatment were considered as covariates. The scale ranged from 0 to 4 (with higher numbers indicating greater severity) for the following six local skin effects: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration (maximum score of 24).
- Area Under the each component of the total LSR-Time Curve (AUC 0-43 days) [ Time Frame: Baseline and on day 43 ]A secondary endpoint was to evaluate and compare the AUC for each component of the total LSR using generalized linear models. The effect of treatment on the proportion of patients that completed the assigned treatment regimens was compared using generalized estimating equation model and logarithmic link function.
- Number of participants with side effects in each arm of the study [ Time Frame: Baseline and on day 43 ]An additional endpoint was to evaluate adverse effects related to the drugs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242747
|Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)|
|Sao Paulo, Brazil, 05403000|
|Principal Investigator:||Luis Antonio Torezan, PhD||Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)|