Actinic KeratosisPhase 4NCT02446223
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%
A Phase 4 study testing Inggenol Mebutate 0.015% in people with Actinic Keratosis, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015% 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?
- Inggenol Mebutate 0.015%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2016
- Phase
- Phase 4
- 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
- Male or female of at least 18 years of age.
- Subjects willing to comply with study requirements.
- The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2.
- For female subjects of childbearing potential willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study.
- A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus, without both ovaries or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide) and abstinence.
- Subjects willing to refrain from the use of topical products containing alpha-hydroxy acids, retinoic acid, retinol, salicylic acid, and vitamins C/D (or their derivatives) in the treatment area 7 Days prior to and during the entire study period
Who cannot join
- Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel.
- Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments.
- Presence of any skin condition or disease that might interfere with the diagnosis and evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis).
- Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study.
- Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study.
- Within 3 months of study entry treatments that may interfere with evaluation of the treatment area (e.g. other topical therapies for actinic keratosis of the chest, topical corticosteroids, topical retinoids, ultraviolet B phototherapy, or immunosuppressive, immunomodulating, or cytotoxic medications) or expected use of any of the above-mentioned therapies in the treatment area listed during the duration of the study.
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- Within 3 months of study entry topical treatment in the treatment area for actinic keratosis including, but not limited to imiquimond, 5- fluorouracil, diclofenac or liquid nitrogen.
- Within 6 months of study entry treatments with Poly-L-lactic acid (PLLA; Sculptra Aesthetic) that may interfere with the evaluation of the treatment area.
- Within 7 days of study entry use of self-tanners, excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of any listed during the time of the study within the treatment area.
- Any systemic disease that is not yet stabilized for at least six (6) Months prior to entering study.
- A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study
- Pregnant or nursing women or women planning a pregnancy during the study period.
- Any unhealed skin lesions or wounds within the treatment area.
- Existence of one (1) or more suspected basal cell carcinoma or squamous cell carcinoma within the treatment area.
- Current participation or participation within 30 days prior to the start of this study in a drug or investigational device research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Pilot Prospective Clinical Trial to Evaluate the Efficacy and Safety of Large-Scale, Field-Directed Topical Therapy of Actinic Keratosis of the Chest With Ingenol Mebutate 0.015%
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%
Read the detailed description
This will be an open-label study to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% used in topical therapy of actinic keratosis on the chest. Subjects that present with 4 or more actinic keratosis in one continuous 100cm2 area of the chest and meet all inclusion/exclusion criteria will be enrolled into this study.
Treatment with the investigational product (IP) will be applied for three continuous days. The investigator will guide application of the IP in-office at Day 0 and the subject will be instructed to self-administer the IP at Days 1 and 2. Follow-up visits will be scheduled at Days 1, 3, 10, 17, 24 and 59.
Prior to treatment and at each visit, the investigator will assess the subject's treatment area for lesion counts and at follow up visits 4, 5, 6 and 7 evaluation of clearance. Pre-treatment photography will also be collected at baseline and at each follow up visit.
- Conditions
- Actinic Keratosis
- Being tested
- Inggenol Mebutate 0.015%
- Keywords
- Actinic Keratosis AKs Chest Pre-Cancer
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inggenol Mebutate 0.015%Drug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Inggenol Mebutate 0.015% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lesion Count From Baseline to Day 59
The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.
Measured: Day 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2016
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 (1)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446223
- Sponsor's protocol ID
- PICATO-2013-01
- Status last verified
- Aug 2019
- First submitted
- 12 May 2015
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wu DC, Guiha I, Goldman MP. A Prospective Pilot Clinical Trial to Evaluate the Efficacy and Safety of Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest. J Clin Aesthet Dermatol. 2017 Aug;10(8):31-36. Epub 2017 Aug 1.
PubMed 28979661
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Clinical Trial to Evaluate the Efficacy and Safety of Large-Scale, Field-Directed Topical Therapy of Actinic Keratosis of the Chest With Ingenol Mebutate 0.015%
- ClinicalTrials.gov ID
- NCT02446223
- Acronym / sponsor ID
- PICATO-2013-01
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis AKs Chest Pre-Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Efficacy and Safety of Large-Scale Field-Directed Topical Therapy of Actinic Keratosis of the Chest w/Ingenol Mebutate 0.015%
Detailed description
This will be an open-label study to evaluate the efficacy and safety of ingenol mebutate gel, 0.015% used in topical therapy of actinic keratosis on the chest. Subjects that present with 4 or more actinic keratosis in one continuous 100cm2 area of the chest and meet all inclusion/exclusion criteria will be enrolled into this study.
Treatment with the investigational product (IP) will be applied for three continuous days. The investigator will guide application of the IP in-office at Day 0 and the subject will be instructed to self-administer the IP at Days 1 and 2. Follow-up visits will be scheduled at Days 1, 3, 10, 17, 24 and 59.
Prior to treatment and at each visit, the investigator will assess the subject's treatment area for lesion counts and at follow up visits 4, 5, 6 and 7 evaluation of clearance. Pre-treatment photography will also be collected at baseline and at each follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Inggenol Mebutate 0.015% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of at least 18 years of age.
- Subjects willing to comply with study requirements.
- The presence of four or more clinically typical actinic keratosis within one contiguous area of the chest that is 100cm2.
- For female subjects of childbearing potential willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study.
- A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus, without both ovaries or has had a bilateral tubal ligation.
Key exclusion criteria (15 listed)
- Known hypersensitivity, prior allergic reaction, or prior chest treatment with ingenol mebutate gel.
- Treatment area containing hypertrophic or hyperkeratotic lesions, cutaneous horns or lesions that had previously not responded to other standard treatments.
- Presence of any skin condition or disease that might interfere with the diagnosis and evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis).
- Subjects receiving ablative laser treatments on their chest must have discontinued the treatment at least 6 months prior to entering the study.
- Subjects receiving Intense Pulse Light treatments on their chest must have discontinued the treatment at least 30 days prior to entering the study.
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 |
|---|---|---|
| Inggenol Mebutate 0.015% | Drug | Active |
Primary outcome
Change in Lesion Count From Baseline to Day 59
Time frame: Day 59
The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28979661Wu DC, Guiha I, Goldman MP. A Prospective Pilot Clinical Trial to Evaluate the Efficacy and Safety of Topical Therapy with Ingenol Mebutate Gel 0.015% for Actinic Keratosis on an Expanded Area of the Chest. J Clin Aesthet Dermatol. 2017 Aug;10(8):31-36. Epub 2017 Aug 1.
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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.
Mitchel P Goldman, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inggenol Mebutate 0.015% in people with Actinic Keratosis, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site 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 15 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Sep 2019). 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?
Change in Lesion Count From Baseline to Day 59 (time frame: Day 59). 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 NCT02446223, which also lists 1 linked publication.
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 6 Sep 2019.