The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are. In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
Placebo suppository, for 3-7 hours application
Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
Department of Obstetrics and Gyneacology, Lille University Hospital
Lille, France
Department of Obstetrics and Gynecology
Hanover, Germany
Fritzøe klinikk
Larvik, Norway
Department of Obstetrics and Gynaecology, Ullevål University Hospital
Oslo, Norway
Complete Response Rate
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Time frame: 6 month
Eradication of HPV
High risk HPV
Time frame: 6 months
Incidence of Patients With Adverse Events
Time frame: 3 months
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Placebo ointment for 5 hours application
Medicus
Trondheim, Norway