Cervical DysplasiaPhase 1/2NCT00369018
A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.
A Phase 1/2 study testing methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) in people with Cervical Dysplasia, run by Photocure at 2 sites in 2 countries.
Trial summary
The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2006to Jul 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive histology of CIN 1-3
Who cannot join
- Patients with endocervical lesions
- Patients with AGUS
- Patients with invasive disease
- Patients with porphyria
- Patients sensitive to MAL and HAL
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Medizinische Hochschule Hannover, Department of Obstetrics and Gynecology
Hanover, 30625
Norway1 site
Ullevål University Hospital, Department of Obstetrics and Gynecology
Oslo, 0407
About this study
Official title: Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
Read the detailed description
Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.
This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.
- Conditions
- Cervical Dysplasia
- Being tested
- methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)
- Keywords
- photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)Drug
MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application
| Study group | Role | What they receive |
|---|---|---|
| MAL 3 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| MAL 12 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 10, 3 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 10, 12 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 40, 3 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 40, 12 | Active comparator | Not described Receives: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion eradication
Measured: 6 months
Secondary outcomes (2)
Eradication of lesion and HPV
Measured: 6 and 12 months
Safety assessment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Hillemanns, Md PhD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369018
- Sponsor's protocol ID
- PC CE101/06
- Status last verified
- Nov 2010
- First submitted
- 28 Aug 2006
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study
- ClinicalTrials.gov ID
- NCT00369018
- Acronym / sponsor ID
- PC CE101/06
- Conditions
- Cervical Dysplasia
- Keywords
- photodynamic therapy, methyl aminolevulinate, hexaminolevulinate, dose-finding, cervical dysplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).
Detailed description
Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.
This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MAL 3 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| MAL 12 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 10, 3 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 10, 12 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 40, 3 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
| HAL 40, 12 | Active comparator | Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive histology of CIN 1-3
Key exclusion criteria (5 listed)
- Patients with endocervical lesions
- Patients with AGUS
- Patients with invasive disease
- Patients with porphyria
- Patients sensitive to MAL and HAL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)MAL 1.2M, HAL 10mM and HAL 40mM solutions for 3 and 12 hours application | Drug | HAL 10, 12, HAL 10, 3, HAL 40, 12, HAL 40, 3, MAL 12, MAL 3 |
Primary outcome
Lesion eradication
Time frame: 6 months
2 secondary outcomes
Eradication of lesion and HPV
Time frame: 6 and 12 months
Safety assessment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hillemanns, Md PhD principal investigator
Hannover Medical School
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) in people with Cervical Dysplasia, run by Photocure at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion eradication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.