Trial · NCT00706433

Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

NCT00706433, Phase 2, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2009-08-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne. Trials, record NCT00706433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00706433

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Trial

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

Title: Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne
NCT number: NCT00706433
Status: Completed
Phases: Phase 2
Enrollment: 266 participants, actual
Lead sponsor: DUSA Pharmaceuticals, Inc.
Conditions: Acne Vulgaris
Interventions: aminolevulinic acid HCL (ALA), Vehicle (VEH)
First posted: 2008-06-27
Last updated: 2011-10-24
Results first posted: 2009-08-21

Source ClinicalTrials.gov

Registered outcomes77

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

List	Outcome	Time frame	Description
Primary	Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 3 weeks after final treatment
Primary	Investigator Global Assessment of Acne Severity Successes	Baseline and 3 weeks after final treatment	Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Secondary	Percent Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 3 weeks after final treatment
Secondary	Percent Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 6 weeks after final treatment
Secondary	Subject Satisfaction Score	6 weeks after final treatment	Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Secondary	Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 6 weeks after final treatment	change in lesion counts compared to baseline
Secondary	Investigator Global Assessment of Acne Severity Successes	Baesline and 6 weeks after final treatment	Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
Secondary	Hyperpigmentation 48 Hours After PDT #1	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
Secondary	Hyperpigmentation at Visit 3 (Week 3)	Visit 3 (Week 3)	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
Secondary	Hyperpigmentation at Visit 5 (Week 6)	Visit 5 (Week 6)	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 77Source ClinicalTrials.gov

See all 77 registered outcomes

Outcomes77

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 3 weeks after final treatment	ITT analysis, LOCF	change in lesion count	MEDIAN
PRIMARY	Investigator Global Assessment of Acne Severity Successes	Baseline and 3 weeks after final treatment	ITT LOCF	participants	NUMBER
SECONDARY	Percent Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 3 weeks after final treatment	ITT LOCF	percent change in lesion count	MEDIAN
SECONDARY	Percent Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 6 weeks after final treatment	ITT LOCF	percent change in lesion count	MEDIAN
SECONDARY	Subject Satisfaction Score	6 weeks after final treatment	ITT, observed	participants	NUMBER
SECONDARY	Change in Inflammatory Lesion Counts Relative to Baseline	Baseline and 6 weeks after final treatment	ITT LOCF	change in lesion count	MEDIAN
SECONDARY	Investigator Global Assessment of Acne Severity Successes	Baesline and 6 weeks after final treatment	ITT LOCF	participants	NUMBER
SECONDARY	Hyperpigmentation 48 Hours After PDT #1	48 hours after PDT #1	ITT, observed	participants	NUMBER
SECONDARY	Hyperpigmentation at Visit 3 (Week 3)	Visit 3 (Week 3)	ITT, observed	participants	NUMBER
SECONDARY	Hyperpigmentation at Visit 5 (Week 6)	Visit 5 (Week 6)	ITT, observed	participants	NUMBER

1 to 10 of 77Source ClinicalTrials.gov

See all 77 outcomes

Results by group1,192

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

Outcome	Group	Category	Value	Spread	Units
Change in Inflammatory Lesion Counts Relative to Baseline	ALA 1000 Seconds		-18.0	Standard Deviation 26.3	change in lesion count
Change in Inflammatory Lesion Counts Relative to Baseline	ALA 500 Seconds		-14.0	Standard Deviation 26.8	change in lesion count
Change in Inflammatory Lesion Counts Relative to Baseline	Vehicle 1000 Seconds		-19.0	Standard Deviation 22.8	change in lesion count
Change in Inflammatory Lesion Counts Relative to Baseline	Vehicle 500 Seconds		-14.5	Standard Deviation 24.0	change in lesion count
Investigator Global Assessment of Acne Severity Successes	ALA 1000 Seconds	Success	13		participants
Investigator Global Assessment of Acne Severity Successes	ALA 500 Seconds	Success	11		participants
Investigator Global Assessment of Acne Severity Successes	Vehicle 1000 Seconds	Success	15		participants
Investigator Global Assessment of Acne Severity Successes	Vehicle 500 Seconds	Success	11		participants
Investigator Global Assessment of Acne Severity Successes	ALA 1000 Seconds	Failure	55		participants
Investigator Global Assessment of Acne Severity Successes	ALA 500 Seconds	Failure	54		participants

1 to 10 of 1,192Source ClinicalTrials.gov

See all 1,192 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ALA 1000 Seconds	68
Overall Study	STARTED	ALA 500 Seconds	65
Overall Study	STARTED	Vehicle 1000 Seconds	67
Overall Study	STARTED	Vehicle 500 Seconds	66
Overall Study	COMPLETED	ALA 1000 Seconds	63
Overall Study	COMPLETED	ALA 500 Seconds	62
Overall Study	COMPLETED	Vehicle 1000 Seconds	57
Overall Study	COMPLETED	Vehicle 500 Seconds	64
Overall Study	NOT COMPLETED	ALA 1000 Seconds	5
Overall Study	NOT COMPLETED	ALA 500 Seconds	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

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	Vomiting	Gastrointestinal disorders	ALA 1000 Seconds	1	68	1
other	Vomiting	Gastrointestinal disorders	ALA 500 Seconds	1	65	1
other	Vomiting	Gastrointestinal disorders	Vehicle 1000 Seconds	1	67	1
other	Vomiting	Gastrointestinal disorders	Vehicle 500 Seconds	3	66	3
other	Upper respiratory tract infection	Infections and infestations	ALA 1000 Seconds	5	68	5
other	Upper respiratory tract infection	Infections and infestations	ALA 500 Seconds	2	65	2
other	Upper respiratory tract infection	Infections and infestations	Vehicle 1000 Seconds	0	67	0
other	Upper respiratory tract infection	Infections and infestations	Vehicle 500 Seconds	5	66	5
other	Headache	Nervous system disorders	ALA 1000 Seconds	5	68	6
other	Headache	Nervous system disorders	ALA 500 Seconds	4	65	9

1 to 10 of 52Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALA 1000 Seconds
Total, all-cause mortality	ALA 500 Seconds
Total, all-cause mortality	Vehicle 1000 Seconds
Total, all-cause mortality	Vehicle 500 Seconds
Total, other adverse events	ALA 1000 Seconds	35
Total, other adverse events	ALA 500 Seconds	38
Total, other adverse events	Vehicle 1000 Seconds	19
Total, other adverse events	Vehicle 500 Seconds	22
Total, serious adverse events	ALA 1000 Seconds	0	68
Total, serious adverse events	ALA 500 Seconds	0	65

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

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

GET https://conductscience.org/api/trials/v1/NCT00706433

GET https://conductscience.org/api/trials/v1/NCT00706433/registered?page=2

API reference For AI assistants