Actinic KeratosisPhase 3NCT02654769
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
A Phase 3 study testing Ingenol Mebutate (Picato®) and Generic Ingenol Mebutate in people with Actinic Keratosis, run by Actavis Inc. at 22 sites in United States.
Trial summary
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol Mebutate (Picato®) and Generic Ingenol Mebutate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 441 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2015to Sep 2015
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was a male or non-pregnant female 18 years of age or older
- Subject provided written informed consent.
- Subject was willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject had a clinical diagnosis of AK at Baseline with at least four (4), but no more than eight (8), visible and discrete non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, within a contiguous 25 cm2 treatment area ("the Treatment Area") on the trunk or extremities.
- Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
- Females must have been post-menopausal , surgically sterile , or have used an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.
Who cannot join
- Subject was pregnant, lactating, or was planning to become pregnant during the study.
- Subject was currently enrolled in an investigational drug or device study.
- Subject used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
- Subject had hyperkeratotic, hypertrophic, or large mat-like AKs (e.g., AK >1 cm2 in size) within the contiguous 25 cm2 Treatment Area.
- Subject had more than eight (8) AKs, independent of size, within the contiguous 25 cm2 Treatment Area.
- Subject had the need or planned to be exposed to artificial tanning devices or excessive sunlight during the trial.
Show all 20Show fewer
- Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft host disease, etc.)
- Subject had experienced an unsuccessful outcome from previous ingenol mebutate therapy (an unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues and the topical drug did not work).
- Subject had a history of sensitivity to any of the ingredients in the test articles (see Section 9.4.2).
- Subject used topical creams, lotions, or gels of any kind within the selected Treatment Area within one (1) day prior to entry into the study.
- Subject used topical medications; corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.
- Subject had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.
- Subject used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one (1) month prior to the Baseline Visit.
- Subject had dermatologic procedures or surgeries such as laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B (UVB) therapy, chemical peels, or dermabrasion on the selected Treatment area (trunk or extremities) within six (6) months prior to the Baseline Visit.
- Subject had lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected Treatment Area (trunk or extremities).
- Subject had any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the test article or required the use of interfering topical, systemic, or surgical therapy.
- Subject had any condition which, in the investigator's opinion, would have made it unsafe or precluded the subject's ability to fully participate in this research study.
- Subject was unable to communicate or cooperate with the investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations.
- Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
- Subject had been previously enrolled in the same study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.Austin
Austin, Texas, 78759
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
Shideler Clinical Research Center
Carmel, Indiana, 46032
Christie Clinic, LLC
Champaign, Illinois, 61820
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Greenville Dermatology, LLC
Greenville, South Carolina, 29607
Bettencourt Skin Center
Henderson, Nevada, 89074
Dermatology Consulting Services
High Point, North Carolina, 27262
The Center for Skin Research
Houston, Texas, 77056
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Dermatology Associates of Knoxville, PC
Knoxville, Tennessee, 37917
Savin Medical Group Research Center
Miami Lakes, Florida, 33014
Union Square Dermatology
New York, New York, 10003
Virginia Clinical Research
Norfolk, Virginia, 23507
Tory P. Sullivan, M.D., P.A.
North Miami Beach, Florida, 33162
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
SD Sports Medicine & Family Health Center
San Diego, California, 92120
Moore Clinical Research, Inc.
Tampa, Florida, 33609
Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886
Warwick, Rhode Island, 02886
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.
Read the detailed description
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol Mebutate (Picato®), Generic Ingenol Mebutate, Vehicle Foam
- 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 (Picato®)Drug
Also called Picato
Brand product
Generic Ingenol MebutateDrug
Generic formulated to have the same therapeutic effect of the brand
Vehicle FoamDrug
Also called Placebo
It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator Picato® | Active comparator | Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)] Receives: Drug: Ingenol Mebutate (Picato®) |
| Generic Ingenol Mebutate | Experimental | Generic ingenol mebutate gel, 0.05% [Test] Receives: Drug: Generic Ingenol Mebutate |
| Vehicle Foam | Placebo comparator | Vehicle gel of the test product Receives: Drug: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome Measure
Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.
Measured: 8 weeks
Secondary outcomes (1)
The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oleg Khatsenko, Ph.D, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654769
- Sponsor's protocol ID
- 094-8151-301
- Status last verified
- Apr 2020
- First submitted
- 12 Jan 2016
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities
- ClinicalTrials.gov ID
- NCT02654769
- Acronym / sponsor ID
- 094-8151-301
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.
Detailed description
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator Picato® | Active comparator | Drug: Ingenol Mebutate (Picato®)Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) [Reference Listed Drug (RLD)] |
| Generic Ingenol Mebutate | Experimental | Drug: Generic Ingenol MebutateGeneric ingenol mebutate gel, 0.05% [Test] |
| Vehicle Foam | Placebo comparator | Drug: Vehicle FoamVehicle gel of the test product |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject was a male or non-pregnant female 18 years of age or older
- Subject provided written informed consent.
- Subject was willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject had a clinical diagnosis of AK at Baseline with at least four (4), but no more than eight (8), visible and discrete non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, within a contiguous 25 cm2 treatment area ("the Treatment Area") on the trunk or extremities.
- Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator's opinion, exposed the subject to an unacceptable risk by study participation.
Key exclusion criteria (20 listed)
- Subject was pregnant, lactating, or was planning to become pregnant during the study.
- Subject was currently enrolled in an investigational drug or device study.
- Subject used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.
- Subject had hyperkeratotic, hypertrophic, or large mat-like AKs (e.g., AK >1 cm2 in size) within the contiguous 25 cm2 Treatment Area.
- Subject had more than eight (8) AKs, independent of size, within the contiguous 25 cm2 Treatment Area.
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 (Picato®)Also: PicatoBrand product | Drug | Active Comparator Picato® |
| Generic Ingenol MebutateGeneric formulated to have the same therapeutic effect of the brand | Drug | Generic Ingenol Mebutate |
| Vehicle FoamAlso: PlaceboIt does not contain active ingredient. A placebo to test the sensitivity of the active treatments. | Drug | Vehicle Foam |
Primary outcome
Primary Efficacy Outcome Measure
Time frame: 8 weeks
Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.
1 secondary outcome
The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Oleg Khatsenko, Ph.D study director
Actavis Inc.
22 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 Ingenol Mebutate (Picato®) and Generic Ingenol Mebutate in people with Actinic Keratosis, run by Actavis Inc. at 22 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 6 inclusion and 20 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 12 May 2020). 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?
Primary Efficacy Outcome Measure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.