DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)


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)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017