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A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279744
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Pharma Power Biotec Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Erythroleukoplakia of Mouth Verrucous Hyperplasia of Oral Mucosa Drug: Radion™-pdt Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : September 4, 2019
Actual Study Completion Date : December 20, 2019

Arm Intervention/treatment
Experimental: Single-Arm
Radion™-pdt
Drug: Radion™-pdt
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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged ≥20 years old;
  2. 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.
  3. Patient who is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

  1. Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
  2. Record of previous unsuccessful treatment with photodynamic therapy;
  3. Patients who have been diagnosed as having oral cancer or carcinoma in situ;
  4. 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;
  5. 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);
  6. Female patient of childbearing potential who:

    • is lactating; or
    • has positive urine pregnancy test at visit -1; or
    • refuses to adopt reliable method of contraception during the study;
  7. Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
  8. Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279744


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist, Taiwan, 100
Sponsors and Collaborators
Pharma Power Biotec Co., Ltd.
Investigators
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Principal Investigator: Hsin-Ming Chen National Taiwan University Hospital
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Responsible Party: Pharma Power Biotec Co., Ltd.
ClinicalTrials.gov Identifier: NCT03279744    
Other Study ID Numbers: IRC241001
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharma Power Biotec Co., Ltd.:
Oral Verrucous Hyperplasia
Oral Erythroleukoplakia
Additional relevant MeSH terms:
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Hyperplasia
Pathologic Processes