Trial Outcomes & Findings for Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1 (NCT NCT00708942)
NCT ID: NCT00708942
Last Updated: 2013-04-24
Results Overview
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
6 month
Results posted on
2013-04-24
Participant Flow
All subjects recruited from medical clinics/hospitals. Start of recruitment arms 1-3: Jan 2009 End of recruitment arms 1-3: Feb 2010 Start of recruitment arms 4-5: Nov 2010 End of recruitment arms 4-5: Jul 2011
Recruitment to part 1, including arms 1-3, completed before initiation of part 2 (arms 4-5). Arms 4 and 5 was a protocol amendment.
Participant milestones
| Measure |
Arm 1: HAL Suppository, Laser Illumination
|
Arm 2: Placebo Suppository, Laser Illumination
|
Arm 3: No Intervention
|
Arm 4: HAL Ointment, LED Diode Illumination
|
Arm 5: Placebo Ointment, no Illumination
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
12
|
11
|
10
|
3
|
|
Overall Study
COMPLETED
|
40
|
11
|
9
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1
Baseline characteristics by cohort
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=47 Participants
|
Arm 2: Placebo Suppository, Laser Illumination
n=12 Participants
|
Arm 3: No Intervention
n=11 Participants
|
Arm 4: HAL Ointment, LED Diode Illumination
n=10 Participants
|
Arm 5: Placebo Ointment, no Illumination
n=3 Participants
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
83 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age Continuous
|
30.2 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
31.0 years
STANDARD_DEVIATION 4.0 • n=21 Participants
|
31.4 years
STANDARD_DEVIATION 7.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
83 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
10 participants
n=8 Participants
|
|
Region of Enrollment
Norway
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
9 participants
n=4 Participants
|
3 participants
n=21 Participants
|
13 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
40 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
60 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 6 monthPopulation: Per protocol population. Patients with major protocol violations excluded.
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Outcome measures
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=35 Participants
|
Arm 2: Placebo Suppository, Laser Illumination
n=10 Participants
|
Arm 3: No Intervention
n=6 Participants
|
Arm 4: HAL Ointment, LED Diode Illumination
n=10 Participants
|
Arm 5: Placebo Ointment, no Illumination
n=3 Participants
|
|---|---|---|---|---|---|
|
Complete Response Rate
|
57.1 percentage of no. of patients analyzed
0
|
40.0 percentage of no. of patients analyzed
0
|
0.0 percentage of no. of patients analyzed
0
|
90.0 percentage of no. of patients analyzed
0
|
33.3 percentage of no. of patients analyzed
0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patients who were positive for high risk HPV at baseline
High risk HPV
Outcome measures
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=20 Participants
|
Arm 2: Placebo Suppository, Laser Illumination
n=7 Participants
|
Arm 3: No Intervention
n=3 Participants
|
Arm 4: HAL Ointment, LED Diode Illumination
n=4 Participants
|
Arm 5: Placebo Ointment, no Illumination
n=3 Participants
|
|---|---|---|---|---|---|
|
Eradication of HPV
|
60.0 percentage of no. of patients analyzed
0
|
28.6 percentage of no. of patients analyzed
0
|
100 percentage of no. of patients analyzed
0
|
50.0 percentage of no. of patients analyzed
0
|
33.3 percentage of no. of patients analyzed
0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All patients treated
Outcome measures
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=47 Participants
|
Arm 2: Placebo Suppository, Laser Illumination
n=12 Participants
|
Arm 3: No Intervention
n=11 Participants
|
Arm 4: HAL Ointment, LED Diode Illumination
n=10 Participants
|
Arm 5: Placebo Ointment, no Illumination
n=3 Participants
|
|---|---|---|---|---|---|
|
Incidence of Patients With Adverse Events
|
44.7 percentage of no of patients analyzed
|
25.0 percentage of no of patients analyzed
|
18.2 percentage of no of patients analyzed
|
70.0 percentage of no of patients analyzed
|
66.7 percentage of no of patients analyzed
|
Adverse Events
Arm 1: HAL Suppository, Laser Illumination
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 2: Placebo Suppository, Laser Illumination
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 3: No Intervention
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 4: HAL Ointment, LED Diode Illumination
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 5: Placebo Ointment, no Illumination
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=47 participants at risk
|
Arm 2: Placebo Suppository, Laser Illumination
n=12 participants at risk
|
Arm 3: No Intervention
n=11 participants at risk
|
Arm 4: HAL Ointment, LED Diode Illumination
n=10 participants at risk
|
Arm 5: Placebo Ointment, no Illumination
n=3 participants at risk
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Jaw fracture
|
2.1%
1/47 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Psychiatric disorders
Schizophrenia
|
2.1%
1/47 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
General disorders
Concomitant disease aggravated
|
2.1%
1/47 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
0.00%
0/47
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/3
|
Other adverse events
| Measure |
Arm 1: HAL Suppository, Laser Illumination
n=47 participants at risk
|
Arm 2: Placebo Suppository, Laser Illumination
n=12 participants at risk
|
Arm 3: No Intervention
n=11 participants at risk
|
Arm 4: HAL Ointment, LED Diode Illumination
n=10 participants at risk
|
Arm 5: Placebo Ointment, no Illumination
n=3 participants at risk
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.3%
2/47 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/47
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
0.00%
0/3
|
|
Infections and infestations
Vaginal infection
|
4.3%
2/47 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.4%
3/47 • Number of events 4
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Vascular disorders
Haemorrhage
|
4.3%
2/47 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Infections and infestations
Influenza
|
0.00%
0/47
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Uterine pain
|
4.3%
2/47 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
General disorders
Pain
|
4.3%
2/47 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.3%
2/47 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
Immune system disorders
Seasonal allergy
|
4.3%
2/47 • Number of events 2
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
0.00%
0/3
|
|
General disorders
Discomfort
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
20.0%
2/10 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/10
|
33.3%
1/3 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.1%
1/47 • Number of events 1
|
0.00%
0/12
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/47
|
0.00%
0/12
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may publish the results from his/her site, provided that the publication does not disclose confidential information or interfere with sponsor's efforts to obtain patent protection for inventions. The sponsor must receive material for review not less than sixty (60) days prior to their proposed submission. In this multi center study, collective publications are anticipated. The PI must not independently publish the results of the Study before the first collective publication.
- Publication restrictions are in place
Restriction type: OTHER