Actinic KeratosisPhase 3NCT01787383

A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

A Phase 3 study testing Ingenol mebutate gel 0.05 % and Ingenol mebutate gel 0.015 % in people with Actinic Keratosis, run by LEO Pharma at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with AKs (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel 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 gel 0.05 % and Ingenol mebutate gel 0.015 %
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteItaly
Study dates: Feb 2013to Jan 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects must provide informed consent
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities
Subjects at least 18 years of age
Female subjects must be of either:
Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.

Who cannot join

Location of the selected treatment areas:
on the periorbital skin
within 5 cm of an incompletely healed wound
within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
Lesions in the selected treatment areas that have:

Show all 30Show fewer

atypical clinical appearance (and/or,
recalcitrant disease
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication
Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas
Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment.
Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application.
Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
Presence of sunburn within the selected treatment areas
Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial
Subjects previously randomised in the trial
Female subjects who are breastfeeding
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol
Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1:
Cosmetic or therapeutic procedures within 2 cm of the selected treatment areas
Use of topical keratolytic therapeutic products within 2 cm of the selected treatment areas
Use of topical medicated creams, ointments, lotions, gels, foams or sprays including topical steroids : within 2 cm of the selected treatment areas; artificial tanners: within 5 cm of the selected treatment areas
Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 1:
Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers
Treatment with systemic medications that suppress the immune system
Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)
Prohibited Therapies and/or Medications within 8 weeks prior to Visit 1:
Treatment with 5-fluorouracil (5-FU), imiquimod, topical diclofenac sodium, or photodynamic therapy within 2 cm of the selected treatment areas.
Prohibited Therapies and/or Medications within 6 months prior to Visit 1:
Use of systemic retinoids or biologic/monoclonal antibody therapies

Trial locations and contacts

1 site in 1 country.

Italy1 site

Clinica Dermatologica dell'Università di Modena e Reggio Emilia
Modena, 41124

Other trials in Italy

About this study

Conditions: Actinic Keratosis
Being tested: Ingenol mebutate gel 0.05 %, Ingenol mebutate gel 0.015 %
Keywords: Actinic Keratosis, Ingenol mebutate gel
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 mebutate gel 0.05 %Drug
Also called Picato®
Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
Ingenol mebutate gel 0.015 %Drug
Also called Picato®
Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially

Study groups in NCT01787383
Study group	Role	What they receive
Ingenol mebutate gel 0.05 %	Active comparator	Not described Receives: Drug: Ingenol mebutate gel 0.05 %; Drug: Ingenol mebutate gel 0.015 %
Ingenol mebutate gel 0.015 %	Active comparator	Not described Receives: Drug: Ingenol mebutate gel 0.05 %; Drug: Ingenol mebutate gel 0.015 %

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area
Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area).
Measured: 3 days after treatment of each selected treatment area

Secondary outcomes (7)

Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as "percentage of participants" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Measured: 8 weeks after treatment
Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as "percentage of participatns" with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Measured: 8 weeks after treatment
Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together "Per Arm" (e.g. "averaged").
Measured: 8 weeks after treatment
Effectiveness Satisfaction Questionnaire for Medication (TSQM)
Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: 8 weeks
Side Effects TSQM
Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: 8 weeks
Global Satisfaction TSQM
Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: 8 weeks
Convenience TSQM
Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Jan 2014

First posted8 Feb 2013 (estimated)
Study startFeb 2013
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Actinic KeratosisStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01787383
Sponsor's protocol ID: LP0041-64
Other IDs: 2012-002863-88
Status last verified: May 2021
First submitted: 6 Feb 2013
Last updated: 24 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24.
PubMed 26300464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities
ClinicalTrials.gov ID: NCT01787383
Acronym / sponsor ID: LP0041-64
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis, Ingenol mebutate gel
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 8 Feb 2013 (estimated)
Results: Posted 7 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ingenol mebutate gel 0.05 %	Active comparator	Drug: Ingenol mebutate gel 0.05 %, Drug: Ingenol mebutate gel 0.015 %
Ingenol mebutate gel 0.015 %	Active comparator	Drug: Ingenol mebutate gel 0.05 %, Drug: Ingenol mebutate gel 0.015 %

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects must provide informed consent
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on face or scalp
Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on trunk or extremities
Subjects at least 18 years of age
Female subjects must be of either:

Key exclusion criteria (30 listed)

Location of the selected treatment areas:
Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities
Lesions in the selected treatment areas that have:
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication
Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected treatment areas

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 mebutate gel 0.05 %Also: Picato®Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially	Drug	Ingenol mebutate gel 0.015 %, Ingenol mebutate gel 0.05 %
Ingenol mebutate gel 0.015 %Also: Picato®Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially	Drug	Ingenol mebutate gel 0.015 %, Ingenol mebutate gel 0.05 %

Primary outcome

Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area
Time frame: 3 days after treatment of each selected treatment area
Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together "Per Arm". Each subject could contribute with up to 2 values (1 for each treated area).

7 secondary outcomes

Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Time frame: 8 weeks after treatment
Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Time frame: 8 weeks after treatment
Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment
Time frame: 8 weeks after treatment
Effectiveness Satisfaction Questionnaire for Medication (TSQM)
Time frame: 8 weeks
Side Effects TSQM
Time frame: 8 weeks
Global Satisfaction TSQM
Time frame: 8 weeks
Convenience TSQM
Time frame: 8 weeks

Results and safety

Results posted to the registry on 7 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ingenol Mebutate Gel Simultaneous Treatment	101	92
Ingenol Mebutate Gel Sequential Treatment	98	76

Primary outcome: Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area

Time frame: 3 days after treatment of each selected treatment area. Mean (Standard Deviation). Unit: units on a scale

Measure	Ingenol Mebutate Gel Simultaneous Treatment n = 101	Ingenol Mebutate Gel Sequential Treatment n = 98
Value	10.4 (5.1)	9.7 (4.5)

Ingenol Mebutate Gel Simultaneous Treatment vs Ingenol Mebutate Gel Sequential Treatment: p = 0.13, Wilcoxon (Mann-Whitney)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ingenol Mebutate Gel Simultaneous Treatment	3 of 101 (3%)	22 of 101 (21.8%)	Not reported
Ingenol Mebutate Gel Sequential Treatment	4 of 98 (4.1%)	22 of 98 (22.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26300464Pellacani G, Peris K, Guillen C, Clonier F, Larsson T, Venkata R, Puig S. A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. J Eur Acad Dermatol Venereol. 2015 Nov;29(11):2192-8. doi: 10.1111/jdv.13211. Epub 2015 Aug 24.

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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.

Medical Expert study director

LEO Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ingenol mebutate gel 0.05 % and Ingenol mebutate gel 0.015 % in people with Actinic Keratosis, run by LEO Pharma at 1 site in Italy.

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 8 inclusion and 30 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 24 Feb 2025. 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 Italy. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area (time frame: 3 days after treatment of each selected treatment area). 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 NCT01787383, 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 24 Feb 2025.