Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia

PHASE2CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

December 31, 2012

Conditions
Cervical Intraepithelial Neoplasia
Interventions
DRUG

HAL 5% with illumination

Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation

DRUG

HAL 1% with illumination

Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation

DRUG

HAL 0.2% with illumination

Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation

DRUG

Placebo ointment without illumination

Treatment with a singe dose of 2g placebo ointment, no photoactivation

Trial Locations (2)

5021

Haukeland University Hospital, Bergen

Unknown

University Hospital Hannover, Hanover

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Photocure

INDUSTRY