Actinic KeratosisNCT02242747
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis
A study testing ingenol mebutate and 5% 5-FU in people with Actinic Keratosis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- ingenol mebutate and 5% 5-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)
São Paulo, São Paulo, 05403000
About this study
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
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.
- Conditions
- Actinic Keratosis
- Being tested
- ingenol mebutate, 5% 5-FU
- Keywords
- actinic keratosis, field cancerization, ingenol mebutate, 5-fluorouracil, tolerability, safety
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ingenol mebutateDrug
Also called Picato
an application a day for three consecutive days in a pre-determined area
5% 5-FUDrug
Also called efurix, efudex
two applications a day for four weeks in a pre-determined area
| Study group | Role | What they receive |
|---|---|---|
| ingenol mebutate | Other | Patients assigned to ingenol mebutate gel received an application a day for three consecutive days in a pre-determined area Receives: Drug: ingenol mebutate |
| 5% 5-FU | Other | Patients assigned to 5% 5-FU received two applications a day for four weeks in a pre-determined area Receives: Drug: 5% 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the LSR (local skin reactions)-Time Curve (AUC 0-43 days)
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).
Measured: Baseline and on day 43
Secondary outcomes (1)
Area Under the each component of the total LSR-Time Curve (AUC 0-43 days)
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.
Measured: Baseline and on day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Luis Antonio Torezan, University of Sao Paulo
- Investigators
- Luis Antonio Torezan, PhD, Principal investigator, Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242747
- Sponsor's protocol ID
- 11334
- Status last verified
- Sep 2014
- First submitted
- 12 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Samorano LP, Torezan LA, Sanches JA. Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5-fluorouracil cream for the treatment of facial actinic keratosis: a prospective randomized trial. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1822-7. doi: 10.1111/jdv.13063. Epub 2015 Feb 27.
PubMed 25727104
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02242747
- Acronym / sponsor ID
- 11334
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, field cancerization, ingenol mebutate, 5-fluorouracil, tolerability, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ingenol mebutate | Other | Drug: ingenol mebutatePatients assigned to ingenol mebutate gel received an application a day for three consecutive days in a pre-determined area |
| 5% 5-FU | Other | Drug: 5% 5-FUPatients assigned to 5% 5-FU received two applications a day for four weeks in a pre-determined area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ingenol mebutateAlso: Picatoan application a day for three consecutive days in a pre-determined area | Drug | ingenol mebutate |
| 5% 5-FUAlso: efurix, efudextwo applications a day for four weeks in a pre-determined area | Drug | 5% 5-FU |
Primary outcome
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).
1 secondary outcome
Area Under the each component of the total LSR-Time Curve (AUC 0-43 days)
Time frame: Baseline and on day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Derived from this study: PubMed 25727104Samorano LP, Torezan LA, Sanches JA. Evaluation of the tolerability and safety of a 0.015% ingenol mebutate gel compared to 5% 5-fluorouracil cream for the treatment of facial actinic keratosis: a prospective randomized trial. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1822-7. doi: 10.1111/jdv.13063. Epub 2015 Feb 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Antonio Torezan, PhD principal investigator
Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ingenol mebutate and 5% 5-FU in people with Actinic Keratosis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the LSR (local skin reactions)-Time Curve (AUC 0-43 days) (time frame: Baseline and on day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.