Actinic KeratosisPhase 3NCT03024060
Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp
A Phase 3 study testing ALA, IBL 20 mW and IBL 10 mW in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a… 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 20 mW and IBL 10 mW
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2017to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
Who cannot join
- Pregnancy
- grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
- 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
Show all 17Show fewer
- unsuccessful outcome from previous ALA-PDT therapy
- currently enrolled in an investigational drug or device study
- 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 active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area
- 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 of initiation of treatment.
- Curettage or Cryotherapy within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- use of systemic retinoid therapy within 6 months of initiation of treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.
Austin, Texas, 78759
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
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP
The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
- Conditions
- Actinic Keratosis
- Being tested
- ALA, Vehicle, IBL 20 mW, IBL 10 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 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
VehicleDrug
Also called Topical Solution Vehicle
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
IBL 20 mWDevice
Also called Investigational Blue Light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
IBL 10 mWDevice
Also called Investigational Blue Light
10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
| Study group | Role | What they receive |
|---|---|---|
| ALA 20 mW | Experimental | ALA + IBL 10J at 20 mW (8min 20 sec) Receives: Drug: ALA; Device: IBL 20 mW |
| ALA 10 mW | Experimental | ALA + IBL 10J at 10 mW (16 min 40 sec) Receives: Drug: ALA; Device: IBL 10 mW |
| Vehicle | Placebo comparator | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group Receives: Drug: Vehicle; Device: IBL 20 mW; Device: IBL 10 mW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Measured: Week 12
Secondary outcomes (5)
Baseline AK Clearance Rate
{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
Measured: Baseline and Week 12
Baseline AK Clearance Rate
{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
Measured: Baseline and Week 8
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Measured: Week 8
Baseline AK Clearance Rate
{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all)
Measured: Baseline and Week 4
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startMar 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionJan 2018 (estimated)
Why it stopped: Study withdrawn due to corporate business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Outcomes assessor
- Enrolment
- 0 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
- NCT03024060
- Sponsor's protocol ID
- CP0114
- Status last verified
- Nov 2017
- First submitted
- 13 Jan 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP
- ClinicalTrials.gov ID
- NCT03024060
- Acronym / sponsor ID
- CP0114
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to corporate business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
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 prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALA 20 mW | Experimental | Drug: ALA, Device: IBL 20 mWALA + IBL 10J at 20 mW (8min 20 sec) |
| ALA 10 mW | Experimental | Drug: ALA, Device: IBL 10 mWALA + IBL 10J at 10 mW (16 min 40 sec) |
| Vehicle | Placebo comparator | Drug: Vehicle, Device: IBL 20 mW, Device: IBL 10 mWVehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group |
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 fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp
Key exclusion criteria (17 listed)
- Pregnancy
- grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area
- 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
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 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light | Drug | ALA 10 mW, ALA 20 mW |
| VehicleAlso: Topical Solution VehicleLevulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light | Drug | Vehicle |
| IBL 20 mWAlso: Investigational Blue Light10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds | Device | ALA 20 mW, Vehicle |
| IBL 10 mWAlso: Investigational Blue Light10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds | Device | ALA 10 mW, Vehicle |
Primary outcome
Complete Clearance Rate
Time frame: Week 12
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
5 secondary outcomes
Baseline AK Clearance Rate
Time frame: Baseline and Week 12
Baseline AK Clearance Rate
Time frame: Baseline and Week 8
Complete Clearance Rate
Time frame: Week 8
Baseline AK Clearance Rate
Time frame: Baseline and Week 4
Complete Clearance Rate
Time frame: Week 4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- 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.
Stuart Marcus, MD, PhD study director
DUSA Pharmaceuticals, Inc.
7 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 ALA, IBL 20 mW and IBL 10 mW in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 7 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 17 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: withdrawn, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was withdrawn before enrolling participants, so there are no results.
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 7 Nov 2017.