Cervical Intraepithelial NeoplasiaPhase 2NCT01256424
Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
A Phase 2 study testing HAL 5% with illumination, HAL 1% with illumination and HAL 0.2% with illumination in people with Cervical Intraepithelial Neoplasia, run by Photocure at 2 sites in 2 countries.
Trial summary
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- HAL 5% with illumination, HAL 1% with illumination and HAL 0.2% with illumination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month
- Satisfactory colposcopy examination including:
- visibility of entire transformation zone including the squamocolumnar junction and
- visibility of entire lesion margin
- Negative endocervical os by colposcopy
- Colposcopical visible lesion at visit 2, before treatment
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- Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap
- Age 18 or above
- Written informed consent signed
Who cannot join
- Previous treatment of CIN or invasive disease
- Lesion(s) extending to the vaginal vault
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease
- Suspicion of endocervical disease on colposcopy
- Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination
- Undiagnosed vaginal bleeding
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- History of toxic shock syndrome
- Known or suspected porphyria
- Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- Pregnancy, or intention to become pregnant during the study period
- Nursing
- Childbirth or miscarriage within six weeks of enrolment
- Use of heart pacemaker
- Participation in other clinical studies either concurrently or within the last 30 days
- Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.
- Unwillingness to use adequate birth control (not abstinence) from screening until last PDT
- Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- HAL 5% with illumination, HAL 1% with illumination, HAL 0.2% with illumination, Placebo ointment without illumination
- Keywords
- CIN
- 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.
HAL 5% with illuminationDrug
Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
HAL 1% with illuminationDrug
Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
HAL 0.2% with illuminationDrug
Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
Placebo ointment without illuminationDrug
Treatment with a singe dose of 2g placebo ointment, no photoactivation
| Study group | Role | What they receive |
|---|---|---|
| HAL 5% with illumination | Experimental | HAL PDT 5% Receives: Drug: HAL 5% with illumination |
| HAL 1% with illumination | Experimental | HAL PDT 1% Receives: Drug: HAL 1% with illumination |
| HAL 0.2% with illumination | Experimental | HAL PDT 0.2% Receives: Drug: HAL 0.2% with illumination |
| Placebo ointment without illumination | Placebo comparator | Placebo without illumination Receives: Drug: Placebo ointment without illumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After 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.
Measured: 3 months after last treatment
Secondary outcomes (1)
Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
HPV response was defined as clearance of baseline HPV infection, asssessed by genotype
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Hillemanns, MD, PhD, Principal investigator, University Hospital Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256424
- Sponsor's protocol ID
- PC CE203/10
- Status last verified
- Apr 2016
- First submitted
- 7 Dec 2010
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hillemanns P, Garcia F, Petry KU, Dvorak V, Sadovsky O, Iversen OE, Einstein MH. A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2. Am J Obstet Gynecol. 2015 Apr;212(4):465.e1-7. doi: 10.1016/j.ajog.2014.10.1107. Epub 2014 Oct 31.
PubMed 25467012
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)
- ClinicalTrials.gov ID
- NCT01256424
- Acronym / sponsor ID
- PC CE203/10
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- CIN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 21 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HAL 5% with illumination | Experimental | Drug: HAL 5% with illuminationHAL PDT 5% |
| HAL 1% with illumination | Experimental | Drug: HAL 1% with illuminationHAL PDT 1% |
| HAL 0.2% with illumination | Experimental | Drug: HAL 0.2% with illuminationHAL PDT 0.2% |
| Placebo ointment without illumination | Placebo comparator | Drug: Placebo ointment without illuminationPlacebo without illumination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month
- Satisfactory colposcopy examination including:
- Negative endocervical os by colposcopy
- Colposcopical visible lesion at visit 2, before treatment
- Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap
Key exclusion criteria (17 listed)
- Previous treatment of CIN or invasive disease
- Lesion(s) extending to the vaginal vault
- Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease
- Suspicion of endocervical disease on colposcopy
- Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination
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 |
|---|---|---|
| HAL 5% with illuminationTreatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation | Drug | HAL 5% with illumination |
| HAL 1% with illuminationTreatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation | Drug | HAL 1% with illumination |
| HAL 0.2% with illuminationTreatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation | Drug | HAL 0.2% with illumination |
| Placebo ointment without illuminationTreatment with a singe dose of 2g placebo ointment, no photoactivation | Drug | Placebo ointment without illumination |
Primary outcome
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Time frame: 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.
1 secondary outcome
Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
Time frame: 3 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25467012Hillemanns P, Garcia F, Petry KU, Dvorak V, Sadovsky O, Iversen OE, Einstein MH. A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2. Am J Obstet Gynecol. 2015 Apr;212(4):465.e1-7. doi: 10.1016/j.ajog.2014.10.1107. Epub 2014 Oct 31.
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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
University Hospital Hannover
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAL 5% with illumination, HAL 1% with illumination and HAL 0.2% with illumination in people with Cervical Intraepithelial Neoplasia, 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 9 inclusion and 17 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 16 May 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. (time frame: 3 months after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256424, which also lists 1 linked publication.
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 16 May 2016.