Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: ingenol mebutate (Drug); 5% 5-FU (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Luis Antonio Torezan, PhD, Principal Investigator, Affiliation: Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under the LSR (local skin reactions)-Time Curve (AUC 0-43 days)
Secondary outcome: Area Under the each component of the total LSR-Time Curve (AUC 0-43 days)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age of at least 18 years
- the presence of four to eight clinically typical, visible, and discrete AKs within
25-cm2 contiguous field on the face (cheek or forehead region)
- Women with childbearing potential had to be using effective birth control and have a
confirmed negative urine pregnancy test prior to trial treatment.
Exclusion Criteria:
- target treatment area was within 5 cm of an incompletely healed wound or within 10 cm
of a suspected basal-cell or squamous-cell carcinoma
- if they have received previous treatment with ingenol mebutate gel on the face or
scalp (previous treatment on trunk or extremities was acceptable)
- the selected treatment area had hyperkeratotic lesions or cutaneous horns and
recalcitrant disease (lesions that had not responded to cryotherapy on two previous
occasions)
- history or evidence of skin conditions that would interfere with the evaluation of
the trial medication (e. g., eczema, unstable psoriasis, xeroderma pigmentosum)
- anticipated need for hospitalization or outpatient surgery during the first 15 days
after the first trial medication application
- known sensitivity or allergy to any of the ingredients of ingenol mebutate gel or
5-FU
- presence of sunburn within of the target treatment area; current enrolment or
participation in any other interventional clinical trial within 30 days of entry into
this trial
- women breastfeeding
- recent use of medications or other treatments that could interfere with evaluation of
the target area, such as topical medications (e. g. steroids, keratolytics,
immunomodulators), artificial tanners, immunomodulators, cytotoxic drugs or
interferon /interferon inducers, phototherapy, systemic retinoids,
biologic/monoclonal antibody drugs, or other therapies for AKs within eight weeks
prior to the first visit of the trial.
Locations and Contacts
Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP), Sao Paulo 05403000, Brazil
Additional Information
Starting date: May 2014
Last updated: September 15, 2014
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