Trial · NCT00708942

Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

NCT00708942, Phase 2, Terminated, Photocure; results first posted 2013-04-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1. Trials, record NCT00708942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00708942

On this page

Trial

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

Title: Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
NCT number: NCT00708942
Status: Terminated
Phases: Phase 2
Enrollment: 83 participants, actual
Lead sponsor: Photocure
Conditions: Cervical Intraepithelial Neoplasia
Interventions: Hexaminolevulinate (HAL), Placebo, Hexaminolevulinate (HAL), Placebo
First posted: 2008-07-03
Last updated: 2013-04-24
Results first posted: 2013-04-15
Limitations and caveats: Slow recruitment lead to early terminaiton of the second part of the trial, including arms 4 and 5, after enrolment of 13 patients. No formal statistical analysis conducted on this part of the data.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Complete Response Rate	6 month	Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Secondary	Eradication of HPV	6 months	High risk HPV
Secondary	Incidence of Patients With Adverse Events	3 months

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Response Rate	6 month	Per protocol population. Patients with major protocol violations excluded.	percentage of no. of patients analyzed	NUMBER
SECONDARY	Eradication of HPV	6 months	Patients who were positive for high risk HPV at baseline	percentage of no. of patients analyzed	NUMBER
SECONDARY	Incidence of Patients With Adverse Events	3 months	All patients treated	percentage of no of patients analyzed	NUMBER

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Units
Complete Response Rate	Arm 1: HAL Suppository, Laser Illumination	57.1	percentage of no. of patients analyzed
Complete Response Rate	Arm 2: Placebo Suppository, Laser Illumination	40.0	percentage of no. of patients analyzed
Complete Response Rate	Arm 3: No Intervention	0.0	percentage of no. of patients analyzed
Complete Response Rate	Arm 4: HAL Ointment, LED Diode Illumination	90.0	percentage of no. of patients analyzed
Complete Response Rate	Arm 5: Placebo Ointment, no Illumination	33.3	percentage of no. of patients analyzed
Eradication of HPV	Arm 1: HAL Suppository, Laser Illumination	60.0	percentage of no. of patients analyzed
Eradication of HPV	Arm 2: Placebo Suppository, Laser Illumination	28.6	percentage of no. of patients analyzed
Eradication of HPV	Arm 3: No Intervention	100	percentage of no. of patients analyzed
Eradication of HPV	Arm 4: HAL Ointment, LED Diode Illumination	50.0	percentage of no. of patients analyzed
Eradication of HPV	Arm 5: Placebo Ointment, no Illumination	33.3	percentage of no. of patients analyzed

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1: HAL Suppository, Laser Illumination	47
Overall Study	STARTED	Arm 2: Placebo Suppository, Laser Illumination	12
Overall Study	STARTED	Arm 3: No Intervention	11
Overall Study	STARTED	Arm 4: HAL Ointment, LED Diode Illumination	10
Overall Study	STARTED	Arm 5: Placebo Ointment, no Illumination	3
Overall Study	COMPLETED	Arm 1: HAL Suppository, Laser Illumination	40
Overall Study	COMPLETED	Arm 2: Placebo Suppository, Laser Illumination	11
Overall Study	COMPLETED	Arm 3: No Intervention	9
Overall Study	COMPLETED	Arm 4: HAL Ointment, LED Diode Illumination	10
Overall Study	COMPLETED	Arm 5: Placebo Ointment, no Illumination	2

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events110

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	Uterine pain	Reproductive system and breast disorders	Arm 1: HAL Suppository, Laser Illumination	2	47	2
other	Uterine pain	Reproductive system and breast disorders	Arm 2: Placebo Suppository, Laser Illumination	1	12	1
other	Uterine pain	Reproductive system and breast disorders	Arm 3: No Intervention	0	11	0
other	Uterine pain	Reproductive system and breast disorders	Arm 4: HAL Ointment, LED Diode Illumination	0	10	0
other	Uterine pain	Reproductive system and breast disorders	Arm 5: Placebo Ointment, no Illumination	0	3	0
other	Pain	General disorders	Arm 1: HAL Suppository, Laser Illumination	2	47	2
other	Pain	General disorders	Arm 2: Placebo Suppository, Laser Illumination	0	12	0
other	Pain	General disorders	Arm 3: No Intervention	0	11	0
other	Pain	General disorders	Arm 4: HAL Ointment, LED Diode Illumination	0	10	0
other	Pain	General disorders	Arm 5: Placebo Ointment, no Illumination	0	3	0

1 to 10 of 110Source ClinicalTrials.gov

See all 110 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1: HAL Suppository, Laser Illumination
Total, all-cause mortality	Arm 2: Placebo Suppository, Laser Illumination
Total, all-cause mortality	Arm 3: No Intervention
Total, all-cause mortality	Arm 4: HAL Ointment, LED Diode Illumination
Total, all-cause mortality	Arm 5: Placebo Ointment, no Illumination
Total, other adverse events	Arm 1: HAL Suppository, Laser Illumination	16	47
Total, other adverse events	Arm 2: Placebo Suppository, Laser Illumination	3	12
Total, other adverse events	Arm 3: No Intervention	1	11
Total, other adverse events	Arm 4: HAL Ointment, LED Diode Illumination	6	10
Total, other adverse events	Arm 5: Placebo Ointment, no Illumination	2	3

1 to 10 of 15Source ClinicalTrials.gov

See all 15 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/NCT00708942

GET https://conductscience.org/api/trials/v1/NCT00708942/events?page=2

API reference For AI assistants