cervical intraepithelial neoplasia(CIN)
Conditions
Interventions
Local administration of aminolevulinic acid jelly 2-3hours before PDT PDT: irradiation for a red light of 635nm for 3-6minutes (total 100J/m2)
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)pathological diagnosis within 3months of the registration of this clinical trial 2)20-50 years-old and premenopausal female 3)ECOG Performance Status(PS) 0-2 4)Patients with organ function is maintained sufficiently 5)Patients with written consent of this clinical trial 6)outpatients
Exclusion criteria
Exclusion criteria: 1)patients with porphyrin hypersensitivity 2)patients with Porphyrias 3)severe drug allergy 4)patients who use a drug causing photosensitivity 5)the patients with other malignant tumors 6)patient with uncontrolled infection 7)patients with myocardial infarction within 6months 8)patients with severe underlying disease 9)patients with severe mental disorders 10)gravida and lactational woman 11)patients judged by investigators as inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety(topical pain,erosion and overall status):at each PDT and 12 and 24weeks after last PDT | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response(CR) rate: 12 and 24weeks after last PDT Treatment time | — |
Countries
Japan
Contacts
Public ContactYoji Hisamatsu
Kansai Medical University Obstetrics and gynecology
Outcome results
None listed