Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical intraepithelial neoplasia (CIN)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Detailed description:
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.

Arms:
arm 1: HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2) arm 2: Placebo suppository (single administration), laser illumination (50J/cm2) arm 3: None arm 4: HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2) arm 5: Placebo ointment (single administration), no illumination

Interventions: intervention 1: Hexaminolevulinate (HAL) intervention 2: Placebo intervention 3: Hexaminolevulinate (HAL) intervention 4: Placebo
Intervention descriptions: intervention 1: Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application intervention 2: Placebo suppository, for 3-7 hours application intervention 3: Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application intervention 4: Placebo ointment for 5 hours application

Protocol document: