Actinic CheilitisPhase 4NCT00849992
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy
A Phase 4 study testing Imiquimod 5% and Photodynamic therapy in people with Actinic Cheilitis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Cheilitis
- What is being tested?
- Imiquimod 5% and Photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Nov 2013
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical findings of actinic cheilitis.
- Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
- Age above 18.
- Willingness to take post-treatment biopsy.
Who cannot join
- Disorders predisposing to photosensitivity (porphyria, SLE).
- Pregnancy or nursing.
- Known allergy to any excipients in the study creams.
- prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.
Read the detailed description
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.
- Conditions
- Actinic Cheilitis
- Being tested
- Imiquimod 5%, Photodynamic therapy
- Keywords
- Actinic cheilitis, Imiquimod 5%, Photodynamic therapy
- Medical subject headings
- Actinic cheilitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 5%Drug
Also called Aldara
Imiquimod 5% cream used three days a week for 4 weeks
Photodynamic therapyProcedure or surgery
Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod 5% | Other | Patients randomized to this arm will receive treatment with imiquimod 5% Receives: Drug: Imiquimod 5% |
| Photodynamic therapy | Other | Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area. Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and pathological complete cure rates.
Measured: 3 and 12 months after therapy
Secondary outcomes (1)
clinical, safety, epidemiological and histopathological data
Through collecting patient data and post-treatment biopsy
Measured: post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic CheilitisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Stein H Sundstrøm, PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849992
- Sponsor's protocol ID
- 20115
- Status last verified
- May 2017
- First submitted
- 23 Feb 2009
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis
- ClinicalTrials.gov ID
- NCT00849992
- Acronym / sponsor ID
- 20115
- Conditions
- Actinic Cheilitis
- Keywords
- Actinic cheilitis, Imiquimod 5%, Photodynamic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Mar 2009 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Feb 2009 (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.
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.
Detailed description
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imiquimod 5% | Other | Drug: Imiquimod 5%Patients randomized to this arm will receive treatment with imiquimod 5% |
| Photodynamic therapy | Other | Procedure: Photodynamic therapyPatients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical findings of actinic cheilitis.
- Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe).
- Age above 18.
- Willingness to take post-treatment biopsy.
Key exclusion criteria (4 listed)
- Disorders predisposing to photosensitivity (porphyria, SLE).
- Pregnancy or nursing.
- Known allergy to any excipients in the study creams.
- prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.
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 |
|---|---|---|
| Imiquimod 5%Also: AldaraImiquimod 5% cream used three days a week for 4 weeks | Drug | Imiquimod 5% |
| Photodynamic therapyPhotodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval. | Procedure or surgery | Photodynamic therapy |
Primary outcome
clinical and pathological complete cure rates.
Time frame: 3 and 12 months after therapy
1 secondary outcome
clinical, safety, epidemiological and histopathological data
Time frame: post-treatment
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 15 May 2017.
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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.
Stein H Sundstrøm, PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod 5% and Photodynamic therapy in people with Actinic Cheilitis, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 4 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
clinical and pathological complete cure rates. (time frame: 3 and 12 months after therapy). 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 15 May 2017.