Actinic KeratosisPhase 3NCT02459795
To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug 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 compared to an FDA approved drug 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
- 469 participants
- Where
- No sites listed yet
- Study dates
- May 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
- IRB approved written informed consent/assent for this study.
- Healthy males or females, at least 18 years of age.
- General good health and free from any clinically significant disease, other than Actinic Keratosis
- Clinical diagnosis of Actinic Keratosis, defined as having 4 to 8 clinically typical, visible and discrete, non-hyperkeratotic, non-hypertrophic, Actinic Keratosis lesions within a contiguous 25cm2 treatment area.
- Willing to refrain from using lotions, sunscreens, moisturizers, cleansers, or creams on the treatment area during the treatment period. Non-Medicated moisturizers, emollients, humectants, sunscreens or similar products used routinely prior to the start of the trial by subjects, may be used after the treatment period.
- Willing to refrain from using any type of bandage or occlusive dressing on the treatment area or applying the gel to open skin wounds, infections or exfoliative dermatitis.
- Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, refrain from use of all other topical Actinic Keratosis medication during the 57 day (8 week) study period, return for the required study visits, comply with therapy prohibitions, and are able to complete the study.
- Females of childbearing potential (excluding women who are surgically sterilized or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.
Who cannot join
- Pregnant, nursing, or planning a pregnancy within the study period.
- Immunocompromised or HIV positive or who have any immune-system disorders including auto-immune diseases.
- Active herpes infection within 14 days prior to the Visit1/Day 1 (Baseline) (i.e., including presence of herpes labialis).
- Any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other cancer in the treatment area.
- Presence of an incompletely healed wound within the treatment area or within 5 cm of the treatment area.
- Presence of any confounding skin conditions in the treatment area that may be made worse by treatment with Ingenol Mebutate gel (e.g., psoriasis, atopic dermatitis, eczema).
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- Subjects who have used a tanning salon and/or tanning booths or have sunbathed or had 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 5 cm of the selected treatment area throughout the study.
- Use of NSAIDs within 7 days from Visit 1/Day 1 (Baseline) or initiation during the study. *Subjects may use Tylenol (Acetaminophen) for pain relief, as needed, throughout the study. Subjects may use low dose aspirin (81mg) for cardiac prophylaxis throughout the study.
- Subjects who had cosmetic or therapeutic procedures such as the following within 2 cm of the selected treatment area within 2 weeks (14 days) of Visit 1/Day 1 (Baseline) and within 10 cm of the selected treatment area planned anytime during the study.
- Cryodestruction/ cryotherapy/liquid nitrogen
- Surgical excision
- Curettage
- Dermabrasion
- Medium or greater depth chemical peel
- Laser resurfacing
- Subjects who have had or are scheduling elective surgery within 1 month (30 days) before or after the study period.
- Use within 1 month (30 days) prior to Visit 1/Day 1 (Baseline) or planned use during the study of:
- Immunomodulators (i.e. azathioprine)
- Immunosuppressive therapies (i.e., cyclosporine, prednisone, methotrexate, alefacept, infliximab)
- Interferon
- Interferon inducers
- Systemic corticosteroids (oral and injectable)
- Cytotoxic drugs (i.e., cyclophosphamide, vinblastine, chlorambucil, methotrexate, podophylllin, camptothecin)
- Subjects who are undergoing treatment or received treatment with the following within 2 months (56 days) of Visit 1/Day 1 (Baseline) and within 2 cm of the selected treatment area or planned anytime during the study.
- 5-Fluorouracil (5-FU)
- Imiquimod
- Diclofenac
- Photodynamic therapy (red or blue light) used in combination with photosensitizing cream (5-aminolaevulinic acid, methyl 5-aminolaevulianate)
- Use of Ingenol Mebutate gel within 2 months (56 days) of Visit 1/Day 1. Previous use (if > 2 months (56 days) of Ingenol Mebutate gel is allowed if a different treatment area was successfully treated.)
- History of unresponsiveness, hypersensitivity or allergy to ingenol mebutate therapy and/or any ingredient in the study medication.
- Subjects who used PUVA (psoralen plus ultraviolet A therapy), or UVB therapy in the treatment area within 6 months (180 days) prior to Visit 1/Day 1 (Baseline) or are planning to receive treatment with PUVA therapy, UVB therapy, nonprescription UV light sources anywhere on the body during the study.
- Subjects who have taken systemic chemotherapy medications within 6 months (180 days) prior to Visit 1/Day 1 (Baseline) or planned use anytime during the study.
- Subjects who have undergone Botox procedures in the selected treatment area 6 months (180 Days) prior to Visit 1/Day 1 (Baseline).
- Subjects who have been treated within 1 month (30 days) or are planning to receive treatment with 1) systemic retinoids (i.e., oral isotretinoin, acitretin, bexarotene), 2) hyaluronic acid, 3) other medicated Actinic Keratosis therapy (i.e., prescription topical retinoids, topical salicyclic acid, bichloroacettic acid, trichloroacetic aid, CO2 laser vaporization, electrocautery), 4) topical steroids (use within 2 cm of the selected treatment area after study Day 15 per PI discretion is allowed) anywhere on the treatment area during the study.
- Subjects who have had a 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. ("Significant change" will be determined by the Principal Investigator)
- Start or change of dose of hormonal treatment (oral, implanted, topical contraceptives and androgens) within the past 3 months (90 days) or planned start or change throughout the study. Use of such therapy must remain constant during 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 (that might influence the intended effects or mask the side effects of study medication) in the 30 days prior to Visit 1/Day 1 (Baseline) or throughout the study.
- Previous enrollment in this study or current enrollment in this study at another participating site.
- Employee (or employee's family member) of the research center or private practice, or subjects who have a conflict of interest.
- 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 compared to an FDA approved drug 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
Also called placebo
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Ingenol Mebutate (Perrigo) Receives: Drug: Ingenol Mebutate (Perrigo) |
| Reference product | Active comparator | Ingenol Mebutate (Reference) 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
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 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
- 469 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
- NCT02459795
- Sponsor's protocol ID
- PRG-NY-15-002
- Status last verified
- Oct 2021
- First submitted
- 29 May 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 Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02459795
- Acronym / sponsor ID
- PRG-NY-15-002
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jun 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 compared to an FDA approved drug 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 (Perrigo) |
| Reference product | Active comparator | Drug: Ingenol Mebutate (Reference)Ingenol Mebutate (Reference) |
| 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)
- IRB approved written informed consent/assent for this study.
- Healthy males or females, at least 18 years of age.
- General good health and free from any clinically significant disease, other than Actinic Keratosis
- Clinical diagnosis of Actinic Keratosis, defined as having 4 to 8 clinically typical, visible and discrete, non-hyperkeratotic, non-hypertrophic, Actinic Keratosis lesions within a contiguous 25cm2 treatment area.
- Willing to refrain from using lotions, sunscreens, moisturizers, cleansers, or creams on the treatment area during the treatment period. Non-Medicated moisturizers, emollients, humectants, sunscreens or similar products used routinely prior to the start of the trial by subjects, may be used after the treatment period.
Key exclusion criteria (42 listed)
- Pregnant, nursing, or planning a pregnancy within the study period.
- Immunocompromised or HIV positive or who have any immune-system disorders including auto-immune diseases.
- Active herpes infection within 14 days prior to the Visit1/Day 1 (Baseline) (i.e., including presence of herpes labialis).
- Any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other cancer in the treatment area.
- Presence of an incompletely healed wound within the treatment area or within 5 cm 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 gelAlso: placebo | Drug | Placebo product |
Primary outcome
Number of Participants With Complete Clearance (Absence) of Actinic Keratosis Lesions
Time frame: Baseline to 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 42 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 (time frame: Baseline to 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.