Trial · NCT01458587
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
NCT01458587, Phase 2, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2013-02-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK). Trials, record NCT01458587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01458587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
- NCT number
- NCT01458587
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 70 participants, actual
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Conditions
- Keratosis, Actinic
- Interventions
- Aminolevulinic Acid PDT (ALA), Vehicle PDT (VEH)
- First posted
- 2011-10-25
- Last updated
- 2013-03-14
- Results first posted
- 2013-02-04
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lesion Clearance Rate | Week 12 | Clearance rate for all lesions |
| Secondary | Lesion Clearance Rate | Week 8 | |
| Secondary | Complete Clearance Rate | Week 8 | proportion of subjects with a count of zero lesions in the treatment area |
| Secondary | Complete Clearance Rate | Week 12 | proportion of subjects with a count of zero lesions in the treatment area |
| Secondary | Partial Clearance Rate | Baseline and 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 and Week 12 | proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. |
| 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 | Hyperpigmentation at Baseline | 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 |
| Secondary | Hyperpigmentation at Visit 3 | 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 |
| Secondary | Hyperpigmentation at Visit 4 | 8 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 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lesion Clearance Rate | Week 12 | ITT analysis with LOCF | percentage of lesions cleared | MEDIAN |
| SECONDARY | Lesion Clearance Rate | Week 8 | ITT LOCF | percentage of lesions cleared | MEDIAN |
| SECONDARY | Complete Clearance Rate | Week 8 | ITT LOCF | arms 100% cleared | NUMBER |
| SECONDARY | Complete Clearance Rate | Week 12 | ITT LOCF | arms 100% cleared | NUMBER |
| SECONDARY | Partial Clearance Rate | Baseline and Week 8 | ITT LOCF | arms >75% cleared | NUMBER |
| SECONDARY | Partial Clearance Rate | Baseline and Week 12 | ITT LOCF | arms >75% cleared | NUMBER |
| SECONDARY | Subject Satisfaction Score | Week 12 | ITT | participants | NUMBER |
| SECONDARY | Hyperpigmentation at Baseline | Baseline | ITT | participants | NUMBER |
| SECONDARY | Hyperpigmentation at Visit 3 | 2 weeks after PDT #1 | ITT | participants | NUMBER |
| SECONDARY | Hyperpigmentation at Visit 4 | 8 weeks after PDT #1 | ITT | participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group584
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lesion Clearance Rate | ALA+OCC | 88.7 | Standard Deviation 25.1 | percentage of lesions cleared | |
| Lesion Clearance Rate | ALA-OCC | 70.0 | Standard Deviation 31.1 | percentage of lesions cleared | |
| Lesion Clearance Rate | VEH+OCC | 16.7 | Standard Deviation 27.6 | percentage of lesions cleared | |
| Lesion Clearance Rate | VEH-OCC | 5.6 | Standard Deviation 26.8 | percentage of lesions cleared | |
| Lesion Clearance Rate | ALA+OCC | 75.0 | Standard Deviation 34.6 | percentage of lesions cleared | |
| Lesion Clearance Rate | ALA-OCC | 47.4 | Standard Deviation 30.7 | percentage of lesions cleared | |
| Lesion Clearance Rate | VEH+OCC | 3.3 | Standard Deviation 28.7 | percentage of lesions cleared | |
| Lesion Clearance Rate | VEH-OCC | 6.3 | Standard Deviation 25.8 | percentage of lesions cleared | |
| Complete Clearance Rate | ALA+OCC | 8 | arms 100% cleared | ||
| Complete Clearance Rate | ALA-OCC | 4 | arms 100% cleared |
1 to 10 of 584Source ClinicalTrials.gov
See all 584 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aminolevulinic Acid | 35 | |
| Overall Study | STARTED | Vehicle | 35 | |
| Overall Study | COMPLETED | Aminolevulinic Acid | 34 | |
| Overall Study | COMPLETED | Vehicle | 35 | |
| Overall Study | NOT COMPLETED | Aminolevulinic Acid | 1 | |
| Overall Study | NOT COMPLETED | Vehicle | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Upper respiratory tract infection | Infections and infestations | Aminolevulinic Acid | 2 | 35 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle | 1 | 35 | 1 |
| other | Wound infection | Infections and infestations | Aminolevulinic Acid | 0 | 35 | 0 |
| other | Wound infection | Infections and infestations | Vehicle | 2 | 35 | 2 |
| other | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Aminolevulinic Acid | 4 | 35 | 5 |
| other | Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle | 0 | 35 | 0 |
| other | Actinic keratosis | Skin and subcutaneous tissue disorders | Aminolevulinic Acid | 0 | 35 | 0 |
| other | Actinic keratosis | Skin and subcutaneous tissue disorders | Vehicle | 2 | 35 | 2 |
| other | Pain | Skin and subcutaneous tissue disorders | Aminolevulinic Acid | 9 | 35 | 10 |
| other | Pain | Skin and subcutaneous tissue disorders | Vehicle | 0 | 35 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aminolevulinic Acid | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Aminolevulinic Acid | 17 | 35 |
| Total, other adverse events | Vehicle | 5 | 35 |
| Total, serious adverse events | Aminolevulinic Acid | 0 | 35 |
| Total, serious adverse events | Vehicle | 0 | 35 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aminolevulinic Acid vs Vehicle: serious adverse events |
Source Trial 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.
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/NCT01458587
GET https://conductscience.org/api/trials/v1/NCT01458587/registered?page=2