Actinic KeratosisNCT01812837
The Use of Microneedles in Photodynamic Therapy
A study testing Microneedle, Aminolevulinic Acid and Blue light in people with Actinic Keratosis, run by University of California, Davis at 1 site in United States.
Trial summary
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Microneedle, Aminolevulinic Acid and Blue light
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are 18 and older
- Subjects who have at least 3 actinic keratoses on each side of the forehead
- Subjects who signed an IRB approved informed consent
Who cannot join
- Subjects who smoke
- Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
- Subjects who received a diagnosis of skin cancer on the face in past year
- Subjects who received field treatment for actinic keratoses to the face in the past 60 days
Trial locations and contacts
1 site in 1 country.
About this study
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses
The specific aims are as follows:
- Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
- Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.
- Conditions
- Actinic Keratosis
- Being tested
- Microneedle, Aminolevulinic Acid, Blue light
- Keywords
- actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedleDevice
Also called Microchannles
The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
Aminolevulinic AcidDrug
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Blue lightRadiation
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
| Study group | Role | What they receive |
|---|---|---|
| 20 minutes incubation - with pretreatment | Experimental | Not described Receives: Device: Microneedle; Drug: Aminolevulinic Acid; Radiation: Blue light |
| 40 minutes incubation - with pretreatment | Experimental | Not described Receives: Device: Microneedle; Drug: Aminolevulinic Acid; Radiation: Blue light |
| 60 minutes incubation - with pretreatment | Experimental | Not described Receives: Device: Microneedle; Drug: Aminolevulinic Acid; Radiation: Blue light |
| 60 minutes incubation - no pretreatment | Sham comparator | Not described Receives: Drug: Aminolevulinic Acid; Radiation: Blue light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actinic Keratoses Reduction Percent
Measured: one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812837
- Sponsor's protocol ID
- 282150
- Status last verified
- May 2017
- First submitted
- 13 Mar 2013
- Last updated
- 15 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Microneedles in Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT01812837
- Acronym / sponsor ID
- 282150
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, microneedles, photodynamic therapy, levulan, Aminolevulinic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Posted 30 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses
The specific aims are as follows:
- Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
- Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 minutes incubation - with pretreatment | Experimental | Device: Microneedle, Drug: Aminolevulinic Acid, Radiation: Blue light |
| 40 minutes incubation - with pretreatment | Experimental | Device: Microneedle, Drug: Aminolevulinic Acid, Radiation: Blue light |
| 60 minutes incubation - with pretreatment | Experimental | Device: Microneedle, Drug: Aminolevulinic Acid, Radiation: Blue light |
| 60 minutes incubation - no pretreatment | Sham comparator | Drug: Aminolevulinic Acid, Radiation: Blue light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are 18 and older
- Subjects who have at least 3 actinic keratoses on each side of the forehead
- Subjects who signed an IRB approved informed consent
Key exclusion criteria (4 listed)
- Subjects who smoke
- Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.
- Subjects who received a diagnosis of skin cancer on the face in past year
- Subjects who received field treatment for actinic keratoses to the face in the past 60 days
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 |
|---|---|---|
| MicroneedleAlso: MicrochannlesThe study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles. | Device | 20 minutes incubation - with pretreatment, 40 minutes incubation - with pretreatment, 60 minutes incubation - with pretreatment |
| Aminolevulinic AcidLevulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA | Drug | 20 minutes incubation - with pretreatment, 40 minutes incubation - with pretreatment, 60 minutes incubation - no pretreatment, 60 minutes incubation - with pretreatment |
| Blue lightBlu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA) | Radiation | 20 minutes incubation - with pretreatment, 40 minutes incubation - with pretreatment, 60 minutes incubation - no pretreatment, 60 minutes incubation - with pretreatment |
Primary outcome
Actinic Keratoses Reduction Percent
Time frame: one month after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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.
Raja K Sivamani, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle, Aminolevulinic Acid and Blue light in people with Actinic Keratosis, run by University of California, Davis 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 3 inclusion and 4 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 15 Jun 2017. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 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?
Actinic Keratoses Reduction Percent (time frame: one month after treatment). 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 15 Jun 2017.