Keratosis, ActinicNCT02594644
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
A study testing Microneedle Roller, Aminolevulinic Acid and Blue Light in people with Keratosis, Actinic, run by University of California, Davis at 1 site in United States.
Trial summary
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Microneedle Roller, Aminolevulinic Acid and Blue Light
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2014to 22 Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older
- Subjects has actinic keratoses and qualifies for photodynamic therapy
- Do not meet any of the exclusion criteria
Who cannot join
- Subjects who smoke
- Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
- Subjects who have established allergy to topical ALA
- Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
About this study
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Read the detailed description
The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
- Conditions
- Keratosis, Actinic
- Being tested
- Microneedle Roller, Aminolevulinic Acid, Blue Light
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle RollerDevice
The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
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 |
|---|---|---|
| 10-minute Incubation with Microneedle Roller & Sham | Experimental | 10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. Receives: Device: Microneedle Roller; Drug: Aminolevulinic Acid; Radiation: Blue Light |
| 20-minute Incubation with Microneedle Roller & Sham | Experimental | 20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. Receives: Device: Microneedle Roller; Drug: Aminolevulinic Acid; Radiation: Blue Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Percentage of Complete Clearance of the Actinic Keratoses
The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
Measured: Baseline, 2 Months
Secondary outcomes (1)
Visual Analog Pain Scale
The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: Immediately Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study start6 Nov 2014
- Primary completion22 Jun 2016
- Study completion22 Jun 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 Keratosis, ActinicStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594644
- Sponsor's protocol ID
- 553703
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2015
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.
PubMed 28514458
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT02594644
- Acronym / sponsor ID
- 553703
- Conditions
- Keratosis, Actinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- 22 Jun 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Posted 29 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Detailed description
The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.
The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-minute Incubation with Microneedle Roller & Sham | Experimental | Device: Microneedle Roller, Drug: Aminolevulinic Acid, Radiation: Blue Light10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. |
| 20-minute Incubation with Microneedle Roller & Sham | Experimental | Device: Microneedle Roller, Drug: Aminolevulinic Acid, Radiation: Blue Light20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Subjects has actinic keratoses and qualifies for photodynamic therapy
- Do not meet any of the exclusion criteria
Key exclusion criteria (4 listed)
- Subjects who smoke
- Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
- Subjects who have established allergy to topical ALA
- Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months
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 |
|---|---|---|
| Microneedle RollerThe study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length. | Device | 10-minute Incubation with Microneedle Roller & Sham, 20-minute Incubation with Microneedle Roller & Sham |
| Aminolevulinic AcidLevulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA | Drug | 10-minute Incubation with Microneedle Roller & Sham, 20-minute Incubation with Microneedle Roller & Sham |
| Blue LightBlu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA | Radiation | 10-minute Incubation with Microneedle Roller & Sham, 20-minute Incubation with Microneedle Roller & Sham |
Primary outcome
Difference in the Percentage of Complete Clearance of the Actinic Keratoses
Time frame: Baseline, 2 Months
The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
1 secondary outcome
Visual Analog Pain Scale
Time frame: Immediately Post-Treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28514458Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.
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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 Sivamani, M.D. principal investigator
University of California, 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 Roller, Aminolevulinic Acid and Blue Light in people with Keratosis, Actinic, 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 29 Nov 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2018). 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?
Difference in the Percentage of Complete Clearance of the Actinic Keratoses (time frame: Baseline, 2 Months). 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 NCT02594644, 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 29 Nov 2018.