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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Photocure
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

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