Actinic KeratosisPhase 2NCT02632110
Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
A Phase 2 study testing ALA, IBL 10 mW and Microneedle lesion preparation in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face. 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?
- ALA, IBL 10 mW and Microneedle lesion preparation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2016to 12 Sep 2016
- Phase
- Phase 2
- 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
- Four to eight AKs on the face
Who cannot join
- Pregnancy
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- Subject is immunosuppressed
- currently enrolled in an investigational drug or device study
Show all 15Show fewer
- has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
- use of the following topical preparations on the extremity to be treated:
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days
- Curettage or Cryotherapy within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
- use of systemic retinoid therapy within 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
MOORE Clinical Research, Inc
Brandon, Florida, 33609
Shideler Clinical Research Center
Carmel, Indiana, 46032
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
UCSD Dermatology
San Diego, California, 92122
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
- Conditions
- Actinic Keratosis
- Being tested
- ALA, Topical Solution Vehicle, IBL 10 mW, Microneedle lesion preparation, IBL 20 mW
- Keywords
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALADrug
Also called Levulan Kerastick, Aminolevulinic acid
20% ALA applied to face prior to light treatment
Topical Solution VehicleDrug
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
IBL 10 mWDevice
Also called Investigational Blue Light (IBL)
10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
Microneedle lesion preparationProcedure or surgery
Microneedling of all visible/palpable AK lesions prior to solution application.
IBL 20 mWDevice
Also called Investigational Blue Light
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
| Study group | Role | What they receive |
|---|---|---|
| ALA 25 min 10 Milliwatts (mW) | Experimental | ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: ALA; Device: IBL 10 mW |
| MN + ALA 25 min 10 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: ALA; Device: IBL 10 mW; Procedure: Microneedle lesion preparation |
| ALA 25 min 20 mW | Experimental | ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. Receives: Drug: ALA; Device: IBL 20 mW |
| MN + ALA 25 min 20 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. Receives: Drug: ALA; Procedure: Microneedle lesion preparation; Device: IBL 20 mW |
| ALA 60 min 10 mW | Experimental | ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: ALA; Device: IBL 10 mW |
| MN + ALA 60 min 10 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: ALA; Device: IBL 10 mW; Procedure: Microneedle lesion preparation |
| ALA 60 min 20 mW | Experimental | ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. Receives: Drug: ALA; Device: IBL 20 mW |
| MN + ALA 60 min 20 mW | Experimental | Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. Receives: Drug: ALA; Procedure: Microneedle lesion preparation; Device: IBL 20 mW |
| VEH | Placebo comparator | Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: Topical Solution Vehicle; Device: IBL 10 mW |
| MN + VEH | Placebo comparator | Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. Receives: Drug: Topical Solution Vehicle; Device: IBL 10 mW; Procedure: Microneedle lesion preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance Rate
Number of AK Fields with 0 lesions
Measured: Week 12
Secondary outcomes (6)
Complete Clearance Rate
Number of AK Fields with 0 Lesions
Measured: Week 8
Subject Satisfaction Score
Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all)
Measured: Week 12
Baseline AKCR
AK clearance rate (AKCR) for only those lesions present at Baseline
Measured: Baseline and Week 8
Baseline AKCR
AK clearance rate for only those lesions present at Baseline
Measured: Baseline and Week 12
Percent Change
Percent change in the total AK number as compared with Baseline
Measured: Baseline and Week 8
Percent Change
Percent change in the total AK number as compared with Baseline
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMar 2016
- Primary completion12 Sep 2016
- Study completion12 Sep 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Marcus, MD, PhD, Study director, DUSA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632110
- Sponsor's protocol ID
- CP0112
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2015
- Last updated
- 18 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Keratoses on the Face
- ClinicalTrials.gov ID
- NCT02632110
- Acronym / sponsor ID
- CP0112
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 12 Sep 2016 (actual)
- Study completion
- 12 Sep 2016 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 13 Dec 2017
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 determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ALA 25 min 10 Milliwatts (mW) | Experimental | Drug: ALA, Device: IBL 10 mWALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| MN + ALA 25 min 10 mW | Experimental | Drug: ALA, Device: IBL 10 mW, Procedure: Microneedle lesion preparationMicroneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| ALA 25 min 20 mW | Experimental | Drug: ALA, Device: IBL 20 mWALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
| MN + ALA 25 min 20 mW | Experimental | Drug: ALA, Procedure: Microneedle lesion preparation, Device: IBL 20 mWMicroneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
| ALA 60 min 10 mW | Experimental | Drug: ALA, Device: IBL 10 mWALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| MN + ALA 60 min 10 mW | Experimental | Drug: ALA, Device: IBL 10 mW, Procedure: Microneedle lesion preparationMicroneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| ALA 60 min 20 mW | Experimental | Drug: ALA, Device: IBL 20 mWALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
| MN + ALA 60 min 20 mW | Experimental | Drug: ALA, Procedure: Microneedle lesion preparation, Device: IBL 20 mWMicroneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. |
| VEH | Placebo comparator | Drug: Topical Solution Vehicle, Device: IBL 10 mWVehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
| MN + VEH | Placebo comparator | Drug: Topical Solution Vehicle, Device: IBL 10 mW, Procedure: Microneedle lesion preparationMicroneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Four to eight AKs on the face
Key exclusion criteria (15 listed)
- Pregnancy
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- Subject is immunosuppressed
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 |
|---|---|---|
| ALAAlso: Levulan Kerastick, Aminolevulinic acid20% ALA applied to face prior to light treatment | Drug | ALA 25 min 10 Milliwatts (mW), ALA 25 min 20 mW, ALA 60 min 10 mW, ALA 60 min 20 mW, MN + ALA 25 min 10 mW, MN + ALA 25 min 20 mW, MN + ALA 60 min 10 mW, MN + ALA 60 min 20 mW |
| Topical Solution VehicleLevulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment | Drug | MN + VEH, VEH |
| IBL 10 mWAlso: Investigational Blue Light (IBL)10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds | Device | ALA 25 min 10 Milliwatts (mW), ALA 60 min 10 mW, MN + ALA 25 min 10 mW, MN + ALA 60 min 10 mW, MN + VEH, VEH |
| Microneedle lesion preparationMicroneedling of all visible/palpable AK lesions prior to solution application. | Procedure or surgery | MN + ALA 25 min 10 mW, MN + ALA 25 min 20 mW, MN + ALA 60 min 10 mW, MN + ALA 60 min 20 mW, MN + VEH |
| IBL 20 mWAlso: Investigational Blue Light10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds | Device | ALA 25 min 20 mW, ALA 60 min 20 mW, MN + ALA 25 min 20 mW, MN + ALA 60 min 20 mW |
Primary outcome
Complete Clearance Rate
Time frame: Week 12
Number of AK Fields with 0 lesions
6 secondary outcomes
Complete Clearance Rate
Time frame: Week 8
Subject Satisfaction Score
Time frame: Week 12
Baseline AKCR
Time frame: Baseline and Week 8
Baseline AKCR
Time frame: Baseline and Week 12
Percent Change
Time frame: Baseline and Week 8
Percent Change
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- 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.
Stuart Marcus, MD, PhD study director
DUSA Pharmaceuticals, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALA, IBL 10 mW and Microneedle lesion preparation in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 8 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 1 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Dec 2017). 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 Rate (time frame: Week 12). 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 18 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.