Actinic KeratosisPhase 3NCT01541553
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
A Phase 3 study testing Cryotherapy and Ingenol metabute in people with Actinic Keratosis, run by LEO Pharma at 35 sites in United States.
Trial summary
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone. 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?
- Cryotherapy and Ingenol metabute
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 35 sitesUnited States
- Study dates
- Mar 2012to Jul 2013
- 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 be competent to understand the nature of the trial and provide informed consent.
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp.
- Subject 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 study treatment, to rule out pregnancy.
- Female subjects of childbearing potential must be willing to use effective contraception.
Who cannot join
- Location of the selected treatment area:
- on any location other than the face or scalp
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected basal cell carcinoma (BCC) or SCC
- Prior treatment with PEP005 Gel on face or scalp.
- Selected treatment area lesions that have:
Show all 29Show fewer
- atypical clinical appearance and/or
- recalcitrant disease
- History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication
- 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.
- Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results.
- Anticipated need for hospitalization 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 PEP005 Gel
- Recent excessive exposure to ultraviolet light
- Current enrolment or participation in a clinical trial within 30 days of entry into this study
- Subjects previously randomised in the trial
- Female subjects who are breastfeeding
- Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1
- Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
- Use of acid-containing therapeutic products within 2 cm of the selected treatment area
- Use of topical medicated creams, ointments, lotions, gels, foams or sprays
- Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1:
- Treatment with immunomodulators, cytotoxic drugs or inter-feron /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-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area.
- Prohibited Therapies and/or Medications within 6 months prior to visit 1
- Use of systemic retinoids or biologic / mono-clonal antibody therapies
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Research Center, Inc.
Arlington, Texas, 76011
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
The Center for Clincial and Cosmetic Research
Aventura, Florida, 33180
Great Lakes Research Center
Bay City, Michigan, 48706
Study Protocol, Inc.
Boynton Beach, Florida, 33437
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Henry Ford Medical Centre - New Center One, Department of Dermatology
Detroit, Michigan, 48202
About Skin Dermatology and DermSurgery, PC
Englewood, Colorado, 80113
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034
Center for Dermatology Clinical Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
Dermatology Research Associates, Inc.
Nashville, Tennessee, 37203
Mount Sinai School of Medicine
New York, New York, 10029
MedaPhase
Newnan, Georgia, 30263
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Specialists, Inc.
Oceanside, California, 92056
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Oregon Health & Science University, Dept. of Dermatology
Portland, Oregon, 97239-6483
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Skin Surgery Medical Group, Inc.
San Diego, California, 92117
University Clinical Trials, Inc.
San Diego, California, 92123
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, 11787
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Premier Clinical Research
Spokane, Washington, 99204
University of South Florida, Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
Grekin Skin Institute
Warren, Michigan, 48088
Center for Clinical Studies
Webster, Texas, 77598
About this study
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
- Conditions
- Actinic Keratosis
- Being tested
- Cryotherapy, Vehicle, Ingenol metabute
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Cryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area
VehicleDrug
Field treatment with vehicle gel once daily for 3 consecutive days.
Ingenol metabuteDrug
Also called Picato® gel, 0.015%
Field treatment with vehicle gel once daily for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| PEP005 Gel, 0.015% | Active comparator | Cryotherapy followed by PEP005 Gel, 0.015% Receives: Procedure: Cryotherapy; Drug: Ingenol metabute |
| Vehicle gel | Placebo comparator | Cryotherapy followed by vehicle gel Receives: Procedure: Cryotherapy; Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance of AKs at Week 11
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Measured: 11 weeks
Secondary outcomes (2)
Percentage Change From Baseline in Number of AKs at Week 11
Percentage change from baseline in number of AKs at Week 11
Measured: Baseline to week 11
Partial Clearance of AKs at Week 11
Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11
Measured: Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2013
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 (2)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Berman, MD, Ph.D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541553
- Sponsor's protocol ID
- LP0041-21
- Status last verified
- Jul 2016
- First submitted
- 17 Feb 2012
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Larsson T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results. J Drugs Dermatol. 2014 Jun;13(6):741-7.
PubMed 24918567Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Goncalves J, Larsson T, Skov T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results. J Drugs Dermatol. 2014 Feb;13(2):154-60.
PubMed 24509965
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
- ClinicalTrials.gov ID
- NCT01541553
- Acronym / sponsor ID
- LP0041-21
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Posted 28 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP005 Gel, 0.015% | Active comparator | Procedure: Cryotherapy, Drug: Ingenol metabuteCryotherapy followed by PEP005 Gel, 0.015% |
| Vehicle gel | Placebo comparator | Procedure: Cryotherapy, Drug: VehicleCryotherapy followed by vehicle gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be competent to understand the nature of the trial and provide informed consent.
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp.
- Subject at least 18 years of age.
- Female subjects must be of either:
- Female subjects of childbearing potential must be willing to use effective contraception.
Key exclusion criteria (29 listed)
- Location of the selected treatment area:
- Prior treatment with PEP005 Gel on face or scalp.
- Selected treatment area lesions that have:
- History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication
- 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.
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 |
|---|---|---|
| CryotherapyCryotherapy of all visible AKs (4-8 lesions, "baseline lesions") in the selected treatment area | Procedure or surgery | PEP005 Gel, 0.015%, Vehicle gel |
| VehicleField treatment with vehicle gel once daily for 3 consecutive days. | Drug | Vehicle gel |
| Ingenol metabuteAlso: Picato® gel, 0.015%Field treatment with vehicle gel once daily for 3 consecutive days. | Drug | PEP005 Gel, 0.015% |
Primary outcome
Complete Clearance of AKs at Week 11
Time frame: 11 weeks
To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
2 secondary outcomes
Percentage Change From Baseline in Number of AKs at Week 11
Time frame: Baseline to week 11
Partial Clearance of AKs at Week 11
Time frame: Week 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24918567Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Larsson T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results. J Drugs Dermatol. 2014 Jun;13(6):741-7.
- Derived from this study: PubMed 24509965Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Goncalves J, Larsson T, Skov T, Swanson N. Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results. J Drugs Dermatol. 2014 Feb;13(2):154-60.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
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.
Brian Berman, MD, Ph.D principal investigator
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cryotherapy and Ingenol metabute in people with Actinic Keratosis, run by LEO Pharma at 35 sites in United States.
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 7 inclusion and 29 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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. Some participants in this study may receive a placebo. 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 28 Mar 2014). 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?
Complete Clearance of AKs at Week 11 (time frame: 11 weeks). 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 NCT01541553, which also lists 2 linked publications.
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 10 Mar 2025.