Trial · NCT01475955

Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

NCT01475955, Phase 2, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2013-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK). Trials, record NCT01475955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01475955

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Trial

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

Title: Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
NCT number: NCT01475955
Status: Completed
Phases: Phase 2
Enrollment: 235 participants, actual
Lead sponsor: DUSA Pharmaceuticals, Inc.
Conditions: Actinic Keratosis
Interventions: Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation, broad area ALA 3-hour incubation, Spot ALA 2 hour incubation, Vehicle PDT, Blue Light Treatment
First posted: 2011-11-22
Last updated: 2016-10-28
Results first posted: 2013-12-24

Source ClinicalTrials.gov

Registered outcomes70

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

List	Outcome	Time frame	Description
Primary	Complete Clearance Rate	Week 12	The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Secondary	Complete Clearance Rate	Week 4	The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Secondary	Complete Clearance Rate	Week 8	The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Secondary	Complete Clearance Rate	Week 24	the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Secondary	Partial Clearance Rate	Baseline, Week 4	proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Secondary	Partial Clearance Rate	Baseline, Week 8	proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Secondary	Partial Clearance Rate	Baseline, Week 12	proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Secondary	Partial Clearance Rate	Baseline Week 24	proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Secondary	AK Clearance Rate	Baseline, Week 4	AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]
Secondary	AK Clearance Rate	Baseline, Week 8	AK Clearance Rate (AKCR) for a subject is defined as: 100% x \[1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)\]

1 to 10 of 70Source ClinicalTrials.gov

See all 70 registered outcomes

Outcomes70

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	Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data	participants	NUMBER
SECONDARY	Complete Clearance Rate	Week 4	ITT LOCF	participants	NUMBER
SECONDARY	Complete Clearance Rate	Week 8		participants	NUMBER
SECONDARY	Complete Clearance Rate	Week 24		participants	NUMBER
SECONDARY	Partial Clearance Rate	Baseline, Week 4		participants	NUMBER
SECONDARY	Partial Clearance Rate	Baseline, Week 8		participants	NUMBER
SECONDARY	Partial Clearance Rate	Baseline, Week 12		participants	NUMBER
SECONDARY	Partial Clearance Rate	Baseline Week 24		participants	NUMBER
SECONDARY	AK Clearance Rate	Baseline, Week 4		percent clearance	MEDIAN
SECONDARY	AK Clearance Rate	Baseline, Week 8		percent clearance	MEDIAN

1 to 10 of 70Source ClinicalTrials.gov

See all 70 outcomes

Results by group1,325

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

Outcome	Group	Value	Units
Complete Clearance Rate	Broad Area ALA 1-hour + BLUE Light Treatment	14	participants
Complete Clearance Rate	Broad Area ALA 2-hour + BLUE Light Treatment	7	participants
Complete Clearance Rate	Broad Area ALA 3-hour + BLUE Light Treatment	13	participants
Complete Clearance Rate	Spot ALA 2-hour + BLUE Light Treatment	8	participants
Complete Clearance Rate	Vehicle + BLUE Light Treatment	1	participants
Complete Clearance Rate	Broad Area ALA 1-hour + BLUE Light Treatment	5	participants
Complete Clearance Rate	Broad Area ALA 2-hour + BLUE Light Treatment	8	participants
Complete Clearance Rate	Broad Area ALA 3-hour + BLUE Light Treatment	5	participants
Complete Clearance Rate	Spot ALA 2-hour + BLUE Light Treatment	4	participants
Complete Clearance Rate	Vehicle + BLUE Light Treatment	0	participants

1 to 10 of 1,325Source ClinicalTrials.gov

See all 1,325 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Broad Area ALA 1-hour + BLUE Light Treatment	48
Overall Study	STARTED	Broad Area ALA 2-hour + BLUE Light Treatment	48
Overall Study	STARTED	Broad Area ALA 3-hour + BLUE Light Treatment	47
Overall Study	STARTED	Spot ALA 2-hour + BLUE Light Treatment	46
Overall Study	STARTED	Vehicle + BLUE Light Treatment	46
Overall Study	COMPLETED	Broad Area ALA 1-hour + BLUE Light Treatment	47
Overall Study	COMPLETED	Broad Area ALA 2-hour + BLUE Light Treatment	48
Overall Study	COMPLETED	Broad Area ALA 3-hour + BLUE Light Treatment	44
Overall Study	COMPLETED	Spot ALA 2-hour + BLUE Light Treatment	46
Overall Study	COMPLETED	Vehicle + BLUE Light Treatment	46

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events90

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	Events
other	squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Broad Area ALA 1-hour	0	48	0
other	squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Broad Area ALA 2-hour	1	48	1
other	squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Broad Area ALA 3-hour	1	47	1
other	squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Spot ALA 2-hour	4	46	4
other	squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Vehicle PDT	4	46	5
serious	Kidney stone	Renal and urinary disorders	Broad Area ALA 1-hour	1	48	1
serious	Kidney stone	Renal and urinary disorders	Broad Area ALA 2-hour	0	48	0
serious	Kidney stone	Renal and urinary disorders	Broad Area ALA 3-hour	0	47	0
serious	Kidney stone	Renal and urinary disorders	Spot ALA 2-hour	0	46	0
serious	Kidney stone	Renal and urinary disorders	Vehicle PDT	0	46	0

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Broad Area ALA 1-hour
Total, all-cause mortality	Broad Area ALA 2-hour
Total, all-cause mortality	Broad Area ALA 3-hour
Total, all-cause mortality	Spot ALA 2-hour
Total, all-cause mortality	Vehicle PDT
Total, other adverse events	Broad Area ALA 1-hour	0	48
Total, other adverse events	Broad Area ALA 2-hour	1	48
Total, other adverse events	Broad Area ALA 3-hour	1	47
Total, other adverse events	Spot ALA 2-hour	4	46
Total, other adverse events	Vehicle PDT	4	46

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38125671	DERIVED

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 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.

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Read this trial from software.

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