Actinic KeratosisPhase 3NCT02385318
To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
A Phase 3 study testing Ingenol Mebutate (Perrigo) and Ingenol Mebutate (Reference) in people with Actinic Keratosis, run by Padagis LLC.
Trial summary
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis. 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 (Perrigo) and Ingenol Mebutate (Reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 519 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent/assent
- Healthy male or non-pregnant females, >18 years old
- Subjects must have clinical diagnosis of actinic keratosis
- Subjects must be in general good health and free from any clinically significant disease that might interfere with the study evaluations in the opinion of the investigator
- Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
- Subjects should be willing to refrain from using any type of bandage or dressing on the treatment area or apply the gel to open skin wounds, infections, or exfoliative dermatitis.
- Subjects must be willing and able to comply with the requirements of the study for the duration of the study period.
- Females of childbearing potential willing to use an acceptable form of birth control
Who cannot join
- Females who are pregnant, nursing, or planning a pregnancy within the study participation period
- Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
- Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
- Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
- Presence of an incompletely healed wound within the treatment area or within 5cm of the treatment area
- Presence of any skin condition in the treatment area that may be made worse by treatment with the study medication
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- Subjects who have used a tanning salon, tanning booth, sunbathing or have excessive prolonged exposure to the sun 7 days prior to Visit 1/Day 1 (baseline) or planned throughout the study
- Subjects who plan to use artificial tanners within 5cm of the selected treatment area throughout the study
- Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the trial.
- Subjects who had select cosmetic or therapeutic procedures within 2cm of the selected treatment area and within 14 days of Visit 1/Day 1 (baseline) or within 10cm of the selected treatment area planned anytime during the study.
- Subjects who have had or are scheduling elective surgery within 1 month before or after the study period
- Prior use within 30 days of Visit 1/ Day 1 (baseline) or planned use during the study of immunomodulators, immunosuppressive therapies, interferon, interferon inducers, systemic corticosteroids, and cytotoxic drugs
- Subjects undergoing treatment or received treatment within 8 weeks of Visit 1/Day 1 (baseline) and within 2cm of the selected area or planned during anytime in the study of: 5-FU, imiquimod, diclofenac, photodynamic therapy used in combination with photosensitizing cream.
- Subjects who used PUVA or UVB therapy on the face or scalp within 6 months prior to Visit 1/Day 1 (baseline) or are planning to receive PUVA therapy, UVB therapy, or nonprescription UV light sources anywhere on the body during the study.
- Subjects who have taken systemic chemotherapy medications within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
- Subjects who have undergone resurfacing procedures within the last 6 months prior to Visit 1/Day 1 (baseline) or planned use anytime during the study.
- Subjects who have been treated within 1 month or planning to receive treatment with systemic retinoids, hyaluronic acid, other medicated actinic keratosis therapy, or topical steroids anywhere on the head during the study.
- Subject who have a history of hypersensitivity or allergy to any ingredient in the drug product.
- Use of medicated make-up in the treatment area or significant change in the use of consumer products within 30 days of Visit 1/Day 1 (baseline) and planned use or change throughout the study.
- Start or change of dose of hormonal treatment within the past 3 months (90 days) or planned start/change throughout the study.
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
- Participation in any clinical study involving an investigational product, agent, or device in the 30 days prior to Visit 1/Day 1 (baseline) or throughout the study
- Subjects who have been previously enrolled in this study
- Employee of the research center or private practice
- Subjects who in the opinion of the investigator are unlikely to be able to follow the restrictions of the protocol and complete the study
About this study
The purpose of this study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol Mebutate (Perrigo), Ingenol Mebutate (Reference), Placebo 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 (Perrigo)Drug
Also called Perrigo product
Ingenol Mebutate (Reference)Drug
Also called Reference Listed Drug Product
Placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Ingenol Mebutate Receives: Drug: Ingenol Mebutate (Perrigo) |
| Reference product | Active comparator | Ingenol Mebutate Receives: Drug: Ingenol Mebutate (Reference) |
| Placebo product | Placebo comparator | Placebo gel Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385318
- Sponsor's protocol ID
- PRG-NY-14-019
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2015
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02385318
- Acronym / sponsor ID
- PRG-NY-14-019
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 22 Jan 2021
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 study is to compare safety and efficacy of Perrigo's drug product compared to an FDA approved drug product in the treatment of actinic keratosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Ingenol Mebutate (Perrigo)Ingenol Mebutate |
| Reference product | Active comparator | Drug: Ingenol Mebutate (Reference)Ingenol Mebutate |
| Placebo product | Placebo comparator | Drug: Placebo gelPlacebo gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent/assent
- Healthy male or non-pregnant females, >18 years old
- Subjects must have clinical diagnosis of actinic keratosis
- Subjects must be in general good health and free from any clinically significant disease that might interfere with the study evaluations in the opinion of the investigator
- Subjects must be willing to refrain from using non-approved products on the targeted treatment area during the study period.
Key exclusion criteria (25 listed)
- Females who are pregnant, nursing, or planning a pregnancy within the study participation period
- Subjects who are immunocompromised or HIV positive or who have any immune-system disorders including auto-immune disease
- Subjects who have or had an active herpes infection within 14 days prior to the baseline visit
- Subjects who have any evidence of carcinoma or any other cancer on the face and scalp
- Presence of an incompletely healed wound within the treatment area or within 5cm of the 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 (Perrigo)Also: Perrigo product | Drug | Test Product |
| Ingenol Mebutate (Reference)Also: Reference Listed Drug Product | Drug | Reference product |
| Placebo gel | Drug | Placebo product |
Primary outcome
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator
Time frame: Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ingenol Mebutate (Perrigo) and Ingenol Mebutate (Reference) in people with Actinic Keratosis, run by Padagis LLC.
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 25 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 22 Jan 2021). 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?
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions as Determined by Visual Inspection of the Investigator (time frame: Day 57). 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 2 Nov 2021.