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

Sponsor
Photocure
Study ID
NCT00708942
Phase
PHASE2
Status
Terminated

Conditions

  • Cervical Intraepithelial Neoplasia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hexaminolevulinate (HAL) — DRUG
    Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application
  • Placebo — DRUG
    Placebo suppository, for 3-7 hours application
  • Hexaminolevulinate (HAL) — DRUG
    Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application
  • Placebo — DRUG
    Placebo ointment for 5 hours application

Study Details

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

Key Dates

Start date
Jan 31, 2009
Status verified
Apr 2013
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2)
  • Placebo Comparator: 2
    Placebo suppository (single administration), laser illumination (50J/cm2)
  • No Intervention: 3
  • Active Comparator: 4
    HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2)
  • Placebo Comparator: 5
    Placebo ointment (single administration), no illumination

Primary Outcome Measure

Complete Response Rate [ Time Frame: 6 month ]

Related Studies