ACTINIC KERATOSISPhase 3NCT03200912
An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% 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 23 sites in United States.
Trial summary
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the… 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
- 507 participants
- Where
- 23 sitesUnited States
- Study dates
- 19 Aug 2016to 22 Mar 2017
- 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 male or non-pregnant female 18 years of age or older.
- Females must have been post-menopausal, surgically sterile, or using an effective method of birth control. Women of childbearing potential (WOCBP) must have had a negative urine pregnancy test (UPT) at Visit 1/Baseline.
- Subject provided written informed consent.
- Subject had a clinical diagnosis of AK at Visit 1/Baseline with at least four, but no more than eight 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") located on the face or scalp.
- 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 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.
Who cannot join
- 1. Subject was pregnant, lactating, or was planning to become pregnant during the study.
- Subject had a location of the selected contiguous 25 cm2 Treatment Area that (a) was within 5 cm of an incompletely healed wound or (b) was in an area containing a lesion that was previously treated with ingenol mebutate.
- 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 AKs, independent of size, within the selected contiguous 25 cm2 Treatment Area
- Subject had atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, xeroderma pigmentosum, or any other possibly confounding skin conditions within the region of the head that contained the selected Treatment Area (i.e., face or scalp).
- Subject had any skin pathology or condition that, in the investigator's opinion, could have interfered with the evaluation of the test article or required the use of interfering topical, systemic, or surgical therapy.
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- Subject was immunosuppressed (e.g., human immunodeficiency virus, systemic malignancy, graft host disease, etc.).
- Subject 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 used topical creams, lotions, or gels of any kind within the selected Treatment Area within one day prior to entry into the study.
- Subject had the need or planned to be exposed to artificial tanning devices or excessive sunlight during the study or had used artificial tanners within two weeks of Visit 1/Baseline.
- Subject had used any of the following topical medications on the face or scalp:
- Corticosteroids within two weeks of Visit 1/Baseline;
- Keratolytic-containing therapeutic products or medicated or irritant topical salves within two weeks of Visit 1/Baseline, including, but not limited to, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), and urea >5%;
- Topical retinoids (e.g., tazarotene, adapalene, tretinoin) within two weeks of Visit 1/Baseline;
- Light treatments (e.g., psoralen plus ultraviolet A therapy, ultraviolet B) within four weeks of Visit 1/Baseline;
- Photodynamic therapy within eight weeks of Visit 1/Baseline;
- 5-fluorouracil, diclofenac, imiquimod, or ingenol mebutate within eight weeks of Visit 1/Baseline; or
- Other topical therapy for actinic keratosis within 2 cm of the selected contiguous 25 cm2 Treatment Area within eight weeks of Visit 1/Baseline.
- Subject had cryodestruction or chemodestruction, surgical excision, curettage, dermabrasion, chemical peel, or laser resurfacing on the Treatment Area (i.e., face or scalp) within two weeks prior to Visit 1/Baseline.
- Subject used any of the following systemic medications:
- Corticosteroid therapy within one month;
- Interferon/interferon inducers, cytotoxic drugs, immuno-modulators, or immunosuppressive therapies within one month;
- Retinoid therapy within six months prior to Visit 1/Baseline.
- Subject had lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected contiguous 25 cm2 Treatment Area on the face or scalp.
- Subject was enrolled in an investigational drug or device study.
- Subject used an investigational drug or investigational device treatment within one month prior to Visit 1/Baseline.
- Subject had a history of sensitivity to any of the ingredients in the test articles (see Section 9.4.2).
- 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 was previously enrolled in the same study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Dermatology
Arlington Heights, Illinois, 60005
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
Moore Clinical Research
Brandon, Florida, 33511
Forefront Dermatology
Carmel, Indiana, 46032
Christie Clinic, LLC
Champaign, Illinois, 61820
University Dermatology & Vein Clinic, LLC
Darien, Illinois, 60561
Horizons Clinical Research Ctr., LLC
Denver, Colorado, 80220
Palmetto Clinical Trial Services
Fountain Inn, South Carolina, 29644
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Consulting Services
High Point, North Carolina, 27262
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
DermReseach New Braunfels
New Braunfels, Texas, 78130
MedaPhase, Inc.
Newnan, Georgia, 30263
Tory P. Sullivan, M.D., P.A.
North Miami Beach, Florida, 33162
Dermatology Specialists, Inc.
Oceanside, California, 92056
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
The South Bend Clinic,LLC
South Bend, Indiana, 46617
Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886
Warwick, Rhode Island, 02886
About this study
Official title: A Multicenter Randomized Doubleblind Vehicle-controlled Parallel Comparison Study to Determine Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.015% and Picato® Gel 0.015% in Subjects With Actinic Keratosis on the Face or Scalp
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
Read the detailed description
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).
- 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 RLD
Brand product
Generic Ingenol MebutateDrug
Also called Test
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 |
|---|---|---|
| Picato | Active comparator | Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) [Reference Listed Drug (RLD)] Receives: Drug: Ingenol Mebutate (Picato®) |
| Generic Ingenol Mebutate | Experimental | Generic ingenol mebutate gel, 0.15% [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.
Complete Clearance of AK Lesions
Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start19 Aug 2016
- Primary completion7 Mar 2017
- Study completion22 Mar 2017
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
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oleg Khatsenko, PhD, Study director, Actavis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200912
- Sponsor's protocol ID
- 094-8152-301
- Status last verified
- Jan 2020
- First submitted
- 14 Jun 2017
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Doubleblind Vehicle-controlled Parallel Comparison Study to Determine Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.015% and Picato® Gel 0.015% in Subjects With Actinic Keratosis on the Face or Scalp
- ClinicalTrials.gov ID
- NCT03200912
- Acronym / sponsor ID
- 094-8152-301
- Conditions
- ACTINIC KERATOSIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2016 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 14 Jan 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, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
Detailed description
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).
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 |
|---|---|---|
| Picato | Active comparator | Drug: Ingenol Mebutate (Picato®)Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) [Reference Listed Drug (RLD)] |
| Generic Ingenol Mebutate | Experimental | Drug: Generic Ingenol MebutateGeneric ingenol mebutate gel, 0.15% [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 male or non-pregnant female 18 years of age or older.
- Females must have been post-menopausal, surgically sterile, or using an effective method of birth control. Women of childbearing potential (WOCBP) must have had a negative urine pregnancy test (UPT) at Visit 1/Baseline.
- Subject provided written informed consent.
- Subject had a clinical diagnosis of AK at Visit 1/Baseline with at least four, but no more than eight 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") located on the face or scalp.
- 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.
Key exclusion criteria (31 listed)
- 1. Subject was pregnant, lactating, or was planning to become pregnant during the study.
- Subject had a location of the selected contiguous 25 cm2 Treatment Area that (a) was within 5 cm of an incompletely healed wound or (b) was in an area containing a lesion that was previously treated with ingenol mebutate.
- 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 AKs, independent of size, within the selected contiguous 25 cm2 Treatment Area
- Subject had atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, xeroderma pigmentosum, or any other possibly confounding skin conditions within the region of the head that contained the selected Treatment Area (i.e., face or scalp).
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: RLDBrand product | Drug | Picato |
| Generic Ingenol MebutateAlso: TestGeneric 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
Complete Clearance of AK Lesions
Time frame: 57 days
Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, PhD study director
Actavis Inc.
23 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 23 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 31 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 14 Jan 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?
Complete Clearance of AK Lesions (time frame: 57 days). 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 14 Jan 2020.