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

NCT ID: NCT00708942

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-01-31

Brief Summary

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

Detailed Description

Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.

In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.

Conditions

Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)

Group Type: ACTIVE_COMPARATOR

Hexaminolevulinate (HAL)

Intervention Type: DRUG

Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application

2

Placebo suppository (single administration), laser illumination (50J/cm2)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo suppository, for 3-7 hours application

3

Group Type: NO_INTERVENTION

No interventions assigned to this group

4

HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)

Group Type: ACTIVE_COMPARATOR

Hexaminolevulinate (HAL)

Intervention Type: DRUG

Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application

5

Placebo ointment (single administration), no illumination

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo ointment for 5 hours application

Interventions

Hexaminolevulinate (HAL)

Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application

Intervention Type: DRUG

Placebo

Placebo suppository, for 3-7 hours application

Intervention Type: DRUG

Hexaminolevulinate (HAL)

Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application

Intervention Type: DRUG

Placebo

Placebo ointment for 5 hours application

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Photocure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hillemanns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Hochschule Hannover, Hannover, Germany

Locations

Department of Obstetrics and Gyneacology, Lille University Hospital

Lille, , France

Department of Obstetrics and Gynecology

Hanover, , Germany

Fritzøe klinikk

Larvik, , Norway

Department of Obstetrics and Gynaecology, Ullevål University Hospital

Oslo, , Norway

Medicus

Trondheim, , Norway

Countries

France; Germany; Norway

Other Identifiers

PC CE201/08

Identifier Type: -

Identifier Source: org_study_id