Trial Outcomes & Findings for Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia (NCT NCT01256424)
NCT ID: NCT01256424
Last Updated: 2016-05-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
262 participants
Primary outcome timeframe
3 months after last treatment
Results posted on
2016-05-16
Participant Flow
Participant milestones
| Measure |
HAL 5% With Illumination
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
62
|
68
|
|
Overall Study
COMPLETED
|
56
|
59
|
55
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
Baseline characteristics by cohort
| Measure |
HAL 5% With Illumination
n=65 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=67 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=62 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=68 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
262 Participants
n=21 Participants
|
|
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
|
|
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
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
262 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: 3 months after last treatmentPopulation: Patients with CIN2 at baseline, based on central histology review
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.
Outcome measures
| Measure |
HAL 5% With Illumination
n=19 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=29 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=19 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=21 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
|
95 percentage of patients
|
69 percentage of patients
|
63 percentage of patients
|
57 percentage of patients
|
SECONDARY outcome
Timeframe: 3 months after treatmentPopulation: Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline
HPV response was defined as clearance of baseline HPV infection, asssessed by genotype
Outcome measures
| Measure |
HAL 5% With Illumination
n=13 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=24 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=17 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=18 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
|
62 percentage of patients
|
38 percentage of patients
|
41 percentage of patients
|
28 percentage of patients
|
POST_HOC outcome
Timeframe: 6 months after first treatmentPopulation: Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.
Response was defined as absence of HSIL, and absence of oncogenic HPV if LSIL.
Outcome measures
| Measure |
HAL 5% With Illumination
n=21 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=22 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=23 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=18 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment.
|
76 percentage of participants
|
45 percentage of participants
|
43 percentage of participants
|
28 percentage of participants
|
POST_HOC outcome
Timeframe: 9 months after first treatmentPopulation: Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.
Response was defined as absence of HSIL, and absence of oncogenic HPF if LSIL
Outcome measures
| Measure |
HAL 5% With Illumination
n=21 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=22 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=23 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=18 Participants
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment
|
76 percentage of participants
|
50 percentage of participants
|
43 percentage of participants
|
33 percentage of participants
|
Adverse Events
HAL 5% With Illumination
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
HAL 1% With Illumination
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
HAL 0.2% With Illumination
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Placebo Ointment Without Illumination
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HAL 5% With Illumination
n=65 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=67 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=62 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=68 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Infections and infestations
Salpingo-oophoritis
|
1.5%
1/65 • Number of events 1
|
0.00%
0/67
|
0.00%
0/62
|
0.00%
0/68
|
|
Infections and infestations
Tubo-ovarian abscess
|
1.5%
1/65 • Number of events 1
|
0.00%
0/67
|
0.00%
0/62
|
0.00%
0/68
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/65
|
1.5%
1/67 • Number of events 1
|
0.00%
0/62
|
0.00%
0/68
|
Other adverse events
| Measure |
HAL 5% With Illumination
n=65 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
|
HAL 1% With Illumination
n=67 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
|
HAL 0.2% With Illumination
n=62 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
|
Placebo Ointment Without Illumination
n=68 participants at risk
Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Local discomfort
|
36.9%
24/65 • Number of events 33
|
17.9%
12/67 • Number of events 15
|
14.5%
9/62 • Number of events 9
|
14.7%
10/68 • Number of events 13
|
|
Reproductive system and breast disorders
Discharge
|
33.8%
22/65 • Number of events 27
|
17.9%
12/67 • Number of events 17
|
14.5%
9/62 • Number of events 10
|
11.8%
8/68 • Number of events 9
|
|
Reproductive system and breast disorders
Spotting
|
9.2%
6/65 • Number of events 6
|
11.9%
8/67 • Number of events 8
|
11.3%
7/62 • Number of events 7
|
5.9%
4/68 • Number of events 6
|
|
Reproductive system and breast disorders
Local infection
|
9.2%
6/65 • Number of events 9
|
3.0%
2/67 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
13.2%
9/68 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • Number of events 2
|
3.0%
2/67 • Number of events 2
|
1.6%
1/62 • Number of events 1
|
2.9%
2/68 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/65 • Number of events 2
|
0.00%
0/67
|
0.00%
0/62
|
0.00%
0/68
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
2/65 • Number of events 2
|
1.5%
1/67 • Number of events 1
|
0.00%
0/62
|
0.00%
0/68
|
|
Infections and infestations
Cystitis
|
1.5%
1/65 • Number of events 1
|
4.5%
3/67 • Number of events 3
|
0.00%
0/62
|
1.5%
1/68 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/65
|
3.0%
2/67 • Number of events 3
|
1.6%
1/62 • Number of events 1
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/65
|
0.00%
0/67
|
1.6%
1/62 • Number of events 1
|
5.9%
4/68 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60