A Dose-finding Study of MAL and HAL Photodynamic Therapy of Cervical Premalignant Lesions.

Photocure

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervical Dysplasia

Treatments: Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369018

PC CE101/06

Details and patient eligibility

About

The study will determine the best drug (MAL or HAL) dosage for photodynamic therapy of cervical precancerous lesions (dysplasia) in women that are referred for conisation (surgery).

Full description

Surgery (conisation) of precancerous cervical lesions (dysplasia) increase the risk of preterm deliveries in young women. Photodynamic therapy (PDT) is a selective, tissue preserving method that may become a good treatment option for these patients.

This study will explore topical application of methyl aminolevulinate (MAL) and hexaminolevulinate (HAL) of the cervix for photodynamic therapy using red light (630 nm). Different doses of MAL and HAL will be used with different application time, followed by illumination.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive histology of CIN 1-3

Exclusion criteria

• Patients with endocervical lesions
• Patients with AGUS
• Patients with invasive disease
• Patients with porphyria
• Patients sensitive to MAL and HAL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 6 patient groups

MAL 3

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

MAL 12

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

HAL 10, 3

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

HAL 10, 12

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

HAL 40, 3

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)

HAL 40, 12

Active Comparator group

Treatment:

Drug: methyl aminolevulinate (MAL) and hexaminolevulinate (HAL)