Trial · NCT01256424
Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
NCT01256424, Phase 2, Completed, Photocure; results first posted 2014-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia. Trials, record NCT01256424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256424
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
- NCT number
- NCT01256424
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 262 participants, actual
- Lead sponsor
- Photocure
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- HAL 5% with illumination, HAL 1% with illumination, HAL 0.2% with illumination, Placebo ointment without illumination
- First posted
- 2010-12-08
- Last updated
- 2016-05-16
- Results first posted
- 2014-08-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | 3 months after last treatment | Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative. |
| Secondary | Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | 3 months after treatment | HPV response was defined as clearance of baseline HPV infection, asssessed by genotype |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | 3 months after last treatment | Patients with CIN2 at baseline, based on central histology review | percentage of patients | NUMBER |
| SECONDARY | Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | 3 months after treatment | Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline | percentage of patients | NUMBER |
| POST_HOC | Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment. | 6 months after first treatment | Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis. | percentage of participants | NUMBER |
| POST_HOC | Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment | 9 months after first treatment | Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 5% With Illumination | 95 | percentage of patients | ||
| Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 1% With Illumination | 69 | percentage of patients | ||
| Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 0.2% With Illumination | 63 | percentage of patients | ||
| Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | Placebo Ointment Without Illumination | 57 | percentage of patients | ||
| Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 5% With Illumination | 62 | percentage of patients | ||
| Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 1% With Illumination | 38 | percentage of patients | ||
| Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | HAL 0.2% With Illumination | 41 | percentage of patients | ||
| Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. | Placebo Ointment Without Illumination | 28 | percentage of patients | ||
| Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment. | HAL 5% With Illumination | 76 | percentage of participants | ||
| Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment. | HAL 1% With Illumination | 45 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HAL 5% With Illumination | 65 | |
| Overall Study | STARTED | HAL 1% With Illumination | 67 | |
| Overall Study | STARTED | HAL 0.2% With Illumination | 62 | |
| Overall Study | STARTED | Placebo Ointment Without Illumination | 68 | |
| Overall Study | COMPLETED | HAL 5% With Illumination | 56 | |
| Overall Study | COMPLETED | HAL 1% With Illumination | 59 | |
| Overall Study | COMPLETED | HAL 0.2% With Illumination | 55 | |
| Overall Study | COMPLETED | Placebo Ointment Without Illumination | 61 | |
| Overall Study | NOT COMPLETED | HAL 5% With Illumination | 9 | |
| Overall Study | NOT COMPLETED | HAL 1% With Illumination | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Local discomfort | Reproductive system and breast disorders | HAL 5% With Illumination | 24 | 65 | 33 |
| other | Local discomfort | Reproductive system and breast disorders | HAL 1% With Illumination | 12 | 67 | 15 |
| other | Local discomfort | Reproductive system and breast disorders | HAL 0.2% With Illumination | 9 | 62 | 9 |
| other | Local discomfort | Reproductive system and breast disorders | Placebo Ointment Without Illumination | 10 | 68 | 13 |
| other | Discharge | Reproductive system and breast disorders | HAL 5% With Illumination | 22 | 65 | 27 |
| other | Discharge | Reproductive system and breast disorders | HAL 1% With Illumination | 12 | 67 | 17 |
| other | Discharge | Reproductive system and breast disorders | HAL 0.2% With Illumination | 9 | 62 | 10 |
| other | Discharge | Reproductive system and breast disorders | Placebo Ointment Without Illumination | 8 | 68 | 9 |
| other | Spotting | Reproductive system and breast disorders | HAL 5% With Illumination | 6 | 65 | 6 |
| other | Spotting | Reproductive system and breast disorders | HAL 1% With Illumination | 8 | 67 | 8 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HAL 5% With Illumination | ||
| Total, all-cause mortality | HAL 1% With Illumination | ||
| Total, all-cause mortality | HAL 0.2% With Illumination | ||
| Total, all-cause mortality | Placebo Ointment Without Illumination | ||
| Total, other adverse events | HAL 5% With Illumination | 40 | 65 |
| Total, other adverse events | HAL 1% With Illumination | 29 | 67 |
| Total, other adverse events | HAL 0.2% With Illumination | 23 | 62 |
| Total, other adverse events | Placebo Ointment Without Illumination | 33 | 68 |
| Total, serious adverse events | HAL 5% With Illumination | 2 | 65 |
| Total, serious adverse events | HAL 1% With Illumination | 1 | 67 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25467012 | 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.
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/NCT01256424
GET https://conductscience.org/api/trials/v1/NCT01256424/events?page=2