Condition 1: Mild Cervical intraepithelial neoplasia. Condition 2: Moderate Cervical intraepithelial neoplasia. Condition 3: Severe cervical dysplasia. Mild cervical dysplasia Moderate cervical dysplasia Severe cervical dysplasia, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: Self-medicate with 250 mg of imiquimod 5% cream intravaginally once a week for 12 weeks. Intervention 2: Control group: Standard excisional treatment.
Sponsors
Oroumia University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Women 18 years of age or older With a histologically confirmed diagnosis of CIN 1, CIN 2, or CIN 3, positive for high-risk human papillomavirus (HPV) Eligible for treatment based on colposcopy findings.
Exclusion criteria
Exclusion criteria: Pregnancy Breastfeeding Immunity deficiency Recent CIN treatment within the past year Any known allergy to imiquimod or any of its components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological regression of CIN to a lower grade or complete remission. Timepoint: Improvement in cytological histology at baseline compared to 6 months after treatment assessed by colposcopy-guided biopsy. Method of measurement: Colposcopy-guided biopsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| HPV clearance rate. Timepoint: 6 months after starting treatment. Method of measurement: Negative high-risk HPV test.;Patient compliance with treatment protocol. Timepoint: From the start of treatment to the end. Method of measurement: Patient follow-up.;Tolerability based on reported side effects. Timepoint: From the start of treatment to the end. Method of measurement: Patient follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParya Aghazadeh
Oroumia University of Medical Sciences
Outcome results
None listed