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

Photocure

Status and phase: Terminated; Phase 2

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: Hexaminolevulinate (HAL); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708942

PC CE201/08

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: Hexaminolevulinate (HAL)

Drug: Hexaminolevulinate (HAL)

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

3

No Intervention group

4

Active Comparator group

Description:

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

Treatment:

Drug: Hexaminolevulinate (HAL)

Drug: Hexaminolevulinate (HAL)

5

Placebo Comparator group

Description:

Placebo ointment (single administration), no illumination

Treatment:

Drug: Placebo

Drug: Placebo