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Trial · NCT02594644

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

NCT02594644, Not applicable, Completed, University of California, Davis; results first posted 2018-11-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy. Trials, record NCT02594644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02594644

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy
NCT number
NCT02594644
Status
Completed
Phases
Not applicable
Enrollment
32 participants, actual
Lead sponsor
University of California, Davis
Conditions
Keratosis, Actinic
Interventions
Microneedle Roller, Aminolevulinic Acid, Blue Light
First posted
2015-11-03
Last updated
2018-11-29
Results first posted
2018-11-29

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDifference in the Percentage of Complete Clearance of the Actinic KeratosesBaseline, 2 MonthsThe primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.
SecondaryVisual Analog Pain ScaleImmediately Post-Treatment
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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYDifference in the Percentage of Complete Clearance of the Actinic KeratosesBaseline, 2 MonthsPercentage of AK ClearanceMEAN
SECONDARYVisual Analog Pain ScaleImmediately Post-TreatmentMillimetersMEAN

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Difference in the Percentage of Complete Clearance of the Actinic Keratoses10-minute Incubation With Microneedle Roller43Standard Error 13Percentage of AK Clearance
Difference in the Percentage of Complete Clearance of the Actinic Keratoses20-minute Incubation With Microneedle Roller76Standard Error 3.9Percentage of AK Clearance
Difference in the Percentage of Complete Clearance of the Actinic Keratoses10-minute Incubation With Sham Microneedles38Standard Error 8.1Percentage of AK Clearance
Difference in the Percentage of Complete Clearance of the Actinic Keratoses20-minute Incubation With Sham Microneedles58Standard Error 5.7Percentage of AK Clearance
Visual Analog Pain ScalePain_microneedle: 10-minute Incubation With Microneedle Roller1.4Standard Error .5Millimeters
Visual Analog Pain ScalePain_microneedle: 20-minute Incubation With Microneedle Roller1.3Standard Error .4Millimeters
Visual Analog Pain ScalePain_microneedle: 10-minute Incubation With Microneedle Sham.3Standard Error .2Millimeters
Visual Analog Pain ScalePain_microneedle: 20-minute Incubation With Microneedle Sham.3Standard Error .2Millimeters
Visual Analog Pain ScalePain_PDT: 10-minute Incubation With Microneedle Sham0.3Standard Error 0.2Millimeters
Visual Analog Pain ScalePain_PDT: 10-minute Incubation With Microneedle Roller.5Standard Error .2Millimeters

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED10-minute Incubation With Microneedle Roller & Sham16
Overall StudySTARTED20-minute Incubation With Microneedle Roller16
Overall StudyCOMPLETED10-minute Incubation With Microneedle Roller & Sham16
Overall StudyCOMPLETED20-minute Incubation With Microneedle Roller15
Overall StudyNOT COMPLETED10-minute Incubation With Microneedle Roller & Sham0
Overall StudyNOT COMPLETED20-minute Incubation With Microneedle Roller1

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality10-minute Incubation With Microneedle Roller & Sham016
Total, all-cause mortality20-minute Incubation With Microneedle Roller & Sham016
Total, other adverse events10-minute Incubation With Microneedle Roller & Sham016
Total, other adverse events20-minute Incubation With Microneedle Roller & Sham016
Total, serious adverse events10-minute Incubation With Microneedle Roller & Sham016
Total, serious adverse events20-minute Incubation With Microneedle Roller & Sham016

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
28514458DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
10-minute Incubation With Microneedle Roller & Sham vs 20-minute Incubation With Microneedle Roller & Sham: deaths from any causeTrial comparisons
10-minute Incubation With Microneedle Roller & Sham vs 20-minute Incubation With Microneedle Roller & Sham: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02594644

GET https://conductscience.org/api/trials/v1/NCT02594644/registered