Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

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

Details

• Lead Sponsor: Photocure
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

• Satisfactory colposcopy examination

• Negative endocervical canal by colposcopy

• Ectocervical CIN1 as verified by local pathologist (biopsy).

• Colposcopical visible lesion at visit 2, before photoactivation

• Written Informed Consent signed

• Age 18 or above

Exclusion Criteria:

• Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease

• Malignant cells on cytology or histology

• Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology

• Suspicion of endocervical disease on colposcopy

• Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination

• Known or suspected porphyria

• Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)

• Use of heart pacemaker

• Pregnancy

• Nursing

• Childbirth or miscarriage within six weeks of enrolment - Known

• Participation in other "competitive" clinical studies either concurrently or within the last 30 days

• Risk of poor protocol compliance

• Not willing to use adequate birth control from screening until last PDT

• Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.