Trial · NCT02632110

Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

NCT02632110, Phase 2, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2017-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face. Trials, record NCT02632110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02632110

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Trial

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

Title: Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
NCT number: NCT02632110
Status: Completed
Phases: Phase 2
Enrollment: 137 participants, actual
Lead sponsor: DUSA Pharmaceuticals, Inc.
Conditions: Actinic Keratosis
Interventions: ALA, Topical Solution Vehicle, IBL 10 mW, Microneedle lesion preparation, IBL 20 mW
First posted: 2015-12-16
Last updated: 2018-01-18
Results first posted: 2017-12-13

Source ClinicalTrials.gov

Registered outcomes46

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

List	Outcome	Time frame	Description
Primary	Complete Clearance Rate	Week 12	Number of AK Fields with 0 lesions
Secondary	Complete Clearance Rate	Week 8	Number of AK Fields with 0 Lesions
Secondary	Subject Satisfaction Score	Week 12	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Secondary	Baseline AKCR	Baseline and Week 8	AK clearance rate (AKCR) for only those lesions present at Baseline
Secondary	Baseline AKCR	Baseline and Week 12	AK clearance rate for only those lesions present at Baseline
Secondary	Percent Change	Baseline and Week 8	Percent change in the total AK number as compared with Baseline
Secondary	Percent Change	Baseline and Week 12	Percent change in the total AK number as compared with Baseline
Other	Hyperpigmentation	Baseline	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Other	Hyperpigmentation	24-48 hours after PDT #1	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Other	Hyperpigmentation	2 Weeks after PDT #1	HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas

1 to 10 of 46Source ClinicalTrials.gov

See all 46 registered outcomes

Outcomes46

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Clearance Rate	Week 12	Split-face study	AK Fields	COUNT_OF_UNITS
SECONDARY	Complete Clearance Rate	Week 8	split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.	AK Fields	COUNT_OF_UNITS
SECONDARY	Subject Satisfaction Score	Week 12	split-face.	AK Fields	COUNT_OF_UNITS
SECONDARY	Baseline AKCR	Baseline and Week 8	split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.	percentage cleared	MEAN
SECONDARY	Baseline AKCR	Baseline and Week 12	split-face	percentage cleared	MEAN
SECONDARY	Percent Change	Baseline and Week 8	split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.	percent change	MEAN
SECONDARY	Percent Change	Baseline and Week 12	split-face	percent change	MEAN
OTHER_PRE_SPECIFIED	Hyperpigmentation	Baseline	split-face	AK Fields	COUNT_OF_UNITS
OTHER_PRE_SPECIFIED	Hyperpigmentation	24-48 hours after PDT #1	split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.	AK Fields	COUNT_OF_UNITS
OTHER_PRE_SPECIFIED	Hyperpigmentation	2 Weeks after PDT #1	split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.	AK Fields	COUNT_OF_UNITS

1 to 10 of 46Source ClinicalTrials.gov

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Results by group1,980

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

Outcome	Group	Value	Units
Complete Clearance Rate	MN + ALA 25 Min 10 mW	16	AK Fields
Complete Clearance Rate	ALA 25 Min 10 mW	15	AK Fields
Complete Clearance Rate	MN + ALA 25 Min 20 mW	10	AK Fields
Complete Clearance Rate	ALA 25 Min 20 mW	12	AK Fields
Complete Clearance Rate	MN + ALA 60 Min 10mW	19	AK Fields
Complete Clearance Rate	ALA 60 Min 10 mW	15	AK Fields
Complete Clearance Rate	MN + ALA 60 Min 20 mW	18	AK Fields
Complete Clearance Rate	ALA 60 Min 20 mW	18	AK Fields
Complete Clearance Rate	MN + VEH	4	AK Fields
Complete Clearance Rate	VEH PDT	4	AK Fields

1 to 10 of 1,980Source ClinicalTrials.gov

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Participant flow30

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

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	MN + ALA 25 Min 10 mW	25	25
Overall Study	STARTED	ALA 25 Min 10 mW	25	25
Overall Study	STARTED	MN + ALA 25 Min 20 mW	27	27
Overall Study	STARTED	ALA 25 Min 20 mW	27	27
Overall Study	STARTED	MN + ALA 60 Min 10mW	29	29
Overall Study	STARTED	ALA 60 Min 10 mW	29	29
Overall Study	STARTED	MN + ALA 60 Min 20 mW	26	26
Overall Study	STARTED	ALA 60 Min 20 mW	26	26
Overall Study	STARTED	MN + VEH 60 Min 10 mW	30	30
Overall Study	STARTED	VEH 60 Min 10 mW	30	30

1 to 10 of 30Source ClinicalTrials.gov

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Adverse events15

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

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	ALA 25 Min 10 mW	0	25
other	Upper respiratory tract infection	Infections and infestations	ALA 25 Min 20 mW	0	27
other	Upper respiratory tract infection	Infections and infestations	ALA 60 Min 10 mW	1	29
other	Upper respiratory tract infection	Infections and infestations	ALA 60 Min 20 mW	0	26
other	Upper respiratory tract infection	Infections and infestations	VEH 60 Min 10 mW	2	30
other	Pain	Injury, poisoning and procedural complications	ALA 25 Min 10 mW	1	25
other	Pain	Injury, poisoning and procedural complications	ALA 25 Min 20 mW	1	27
other	Pain	Injury, poisoning and procedural complications	ALA 60 Min 10 mW	3	29
other	Pain	Injury, poisoning and procedural complications	ALA 60 Min 20 mW	7	26
other	Pain	Injury, poisoning and procedural complications	VEH 60 Min 10 mW	0	30

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALA 25 Min 10 mW	0	25
Total, all-cause mortality	ALA 25 Min 20 mW	0	27
Total, all-cause mortality	ALA 60 Min 10 mW	0	29
Total, all-cause mortality	ALA 60 Min 20 mW	0	26
Total, all-cause mortality	VEH 60 Min 10 mW	0	30
Total, other adverse events	ALA 25 Min 10 mW	1	25
Total, other adverse events	ALA 25 Min 20 mW	1	27
Total, other adverse events	ALA 60 Min 10 mW	4	29
Total, other adverse events	ALA 60 Min 20 mW	7	26
Total, other adverse events	VEH 60 Min 10 mW	2	30

1 to 10 of 15Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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.

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