Trial · NCT02137785
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
NCT02137785, Phase 3, Completed, DUSA Pharmaceuticals, Inc.; results first posted 2015-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities. Trials, record NCT02137785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02137785
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
- NCT number
- NCT02137785
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 269 participants, actual
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Conditions
- Actinic Keratosis
- Interventions
- Aminolevulinic Acid (ALA), Topical Solution Vehicle, Blue Light Photodynamic Therapy Illuminator (BLU-U)
- First posted
- 2014-05-14
- Last updated
- 2015-09-16
- Results first posted
- 2015-09-16
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Clearance Rate | Week 12 | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area |
| Secondary | AK Clearance Rate | Baseline and Week 12 | {1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100 |
| Secondary | AK Clearance Rate | Baseline and Week 8 | {1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100 |
| Secondary | Complete Clearance Rate | Week 8 | proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area |
| 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) |
| 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 |
| Other | Hyperpigmentation | 4 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 |
| Other | Hyperpigmentation | 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 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
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 | ITT | participants | NUMBER |
| SECONDARY | AK Clearance Rate | Baseline and Week 12 | ITT using observed data only | percentage of baseline lesions cleared | MEAN |
| SECONDARY | AK Clearance Rate | Baseline and Week 8 | ITT using observed data only | percentage of baseline lesions cleared | MEAN |
| SECONDARY | Complete Clearance Rate | Week 8 | ITT | participants | NUMBER |
| SECONDARY | Subject Satisfaction Score | Week 12 | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hyperpigmentation | Baseline | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hyperpigmentation | 24-48 hours after PDT #1 | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hyperpigmentation | 2 Weeks after PDT #1 | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hyperpigmentation | 4 Weeks after PDT #1 | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Hyperpigmentation | 8 Weeks after PDT #1 | ITT | participants | NUMBER |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group460
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Clearance Rate | ALA-PDT | 42 | participants | ||
| Complete Clearance Rate | Vehicle | 17 | participants | ||
| AK Clearance Rate | ALA-PDT | 69.1 | Standard Deviation 37.4 | percentage of baseline lesions cleared | |
| AK Clearance Rate | Vehicle | 29.9 | Standard Deviation 51.5 | percentage of baseline lesions cleared | |
| AK Clearance Rate | ALA-PDT | 53.4 | Standard Deviation 45.0 | percentage of baseline lesions cleared | |
| AK Clearance Rate | Vehicle | 26.3 | Standard Deviation 44.3 | percentage of baseline lesions cleared | |
| Complete Clearance Rate | ALA-PDT | 35 | participants | ||
| Complete Clearance Rate | Vehicle | 12 | participants | ||
| Subject Satisfaction Score | ALA-PDT | Very Satisfied | 71 | participants | |
| Subject Satisfaction Score | Vehicle | Very Satisfied | 29 | participants |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALA-PDT | 135 | |
| Overall Study | STARTED | Vehicle | 134 | |
| Overall Study | COMPLETED | ALA-PDT | 132 | |
| Overall Study | COMPLETED | Vehicle | 130 | |
| Overall Study | NOT COMPLETED | ALA-PDT | 3 | |
| Overall Study | NOT COMPLETED | Vehicle | 4 |
Source ClinicalTrials.gov
Adverse events26
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 | Nasopharyngitis | Infections and infestations | ALA-PDT | 2 | 135 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle | 4 | 134 | |
| other | Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ALA-PDT | 4 | 135 | |
| other | Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle | 2 | 134 | |
| serious | Angina Unstable | Cardiac disorders | ALA-PDT | 1 | 135 | 1 |
| serious | Angina Unstable | Cardiac disorders | Vehicle | 0 | 134 | 0 |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | ALA-PDT | 0 | 135 | |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Vehicle | 1 | 134 | 1 |
| serious | Atrial Fibrillation | Cardiac disorders | ALA-PDT | 1 | 135 | 1 |
| serious | Atrial Fibrillation | Cardiac disorders | Vehicle | 0 | 134 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALA-PDT | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | ALA-PDT | 6 | 135 |
| Total, other adverse events | Vehicle | 6 | 134 |
| Total, serious adverse events | ALA-PDT | 5 | 135 |
| Total, serious adverse events | Vehicle | 2 | 134 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ALA-PDT vs Vehicle: Complete Clearance Rate | Trial comparisons |
| ALA-PDT vs Vehicle: Complete Clearance Rate | Trial comparisons |
| ALA-PDT vs Vehicle: serious adverse events | 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/NCT02137785
GET https://conductscience.org/api/trials/v1/NCT02137785/registered?page=2