Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief summary:
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Detailed description:

Arms:
arm 1: HAL PDT 5% arm 2: HAL PDT 1% arm 3: HAL PDT 0.2% arm 4: Placebo without illumination

Interventions: intervention 1: HAL 5% with illumination intervention 2: HAL 1% with illumination intervention 3: HAL 0.2% with illumination intervention 4: Placebo ointment without illumination
Intervention descriptions: intervention 1: Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation intervention 2: Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation intervention 3: Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation intervention 4: Treatment with a singe dose of 2g placebo ointment, no photoactivation

Protocol document: