Erythroleukoplakia of MouthPhase 2NCT03279744
A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion
A Phase 2 study testing Radion™-pdt in people with Erythroleukoplakia of Mouth and Verrucous Hyperplasia of Oral Mucosa, run by Pharma Power Biotec Co., Ltd. at 1 site in Taiwan.
Trial summary
A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Erythroleukoplakia of Mouth, Verrucous Hyperplasia of Oral Mucosa
- What is being tested?
- Radion™-pdt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2017to 20 Dec 2019
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥20 years old;
- Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
- Patient who is willing and able to comply with study procedures and sign informed consent
Who cannot join
- Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
- Record of previous unsuccessful treatment with photodynamic therapy;
- Patients who have been diagnosed as having oral cancer or carcinoma in situ;
- Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
- Patients with impaired hepatic function (defined as AST and/or ALT > 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine > 1.5 mg/dL);
- Female patient of childbearing potential who:
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- is lactating; or
- has positive urine pregnancy test at visit -1; or
- refuses to adopt reliable method of contraception during the study;
- Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
- Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)
A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).
Read the detailed description
This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL).
Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows:
- Screening (within 2 weeks before dosing)
- Treatment period (up to 14 weeks)
- Safety follow-up period (within 2 weeks after final treatment)
- Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.
- Being tested
- Radion™-pdt
- Keywords
- Oral Verrucous Hyperplasia, Oral Erythroleukoplakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radion™-pdtDrug
The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Radion™-pdt Receives: Drug: Radion™-pdt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total
The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total.
Complete response (CR): lack of detectable lesion confirmed by visual evaluation.
Measured: 2-week safety follow-up period after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start6 Sep 2017
- Primary completion4 Sep 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythroleukoplakia of MouthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharma Power Biotec Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsin-Ming Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279744
- Sponsor's protocol ID
- IRC241001
- Status last verified
- Dec 2019
- First submitted
- 8 Sep 2017
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label, Phase II. Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-Pdt in Patients With Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia)
- ClinicalTrials.gov ID
- NCT03279744
- Acronym / sponsor ID
- IRC241001
- Keywords
- Oral Verrucous Hyperplasia, Oral Erythroleukoplakia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pharma Power Biotec Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).
Detailed description
This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL).
Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows:
- Screening (within 2 weeks before dosing)
- Treatment period (up to 14 weeks)
- Safety follow-up period (within 2 weeks after final treatment)
- Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: Radion™-pdtRadion™-pdt |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥20 years old;
- Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
- Patient who is willing and able to comply with study procedures and sign informed consent
Key exclusion criteria (11 listed)
- Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
- Record of previous unsuccessful treatment with photodynamic therapy;
- Patients who have been diagnosed as having oral cancer or carcinoma in situ;
- Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
- Patients with impaired hepatic function (defined as AST and/or ALT > 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine > 1.5 mg/dL);
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 |
|---|---|---|
| Radion™-pdtThe Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion. | Drug | Single-Arm |
Primary outcome
The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total
Time frame: 2-week safety follow-up period after last treatment
The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total. Complete response (CR): lack of detectable lesion confirmed by visual evaluation.
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 2 Jan 2020.
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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.
Hsin-Ming Chen principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radion™-pdt in people with Erythroleukoplakia of Mouth and Verrucous Hyperplasia of Oral Mucosa, run by Pharma Power Biotec Co., Ltd. at 1 site in Taiwan.
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 3 inclusion and 11 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 2 Jan 2020. 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 Taiwan. 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 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?
The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total (time frame: 2-week safety follow-up period after last treatment). 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 2 Jan 2020.