Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix

• Status: Completed
• Trial end date: 2017-05-09
• Target enrollment: 0
• Participant gender: Female

Summary

OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United States Naval Medical Center, San Diego
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Healthy women older than age 21, military or civilian

• Negative pregnancy test results

• Confirmed CIN 2-3 on cervical biopsy with a negative endocervical curettage (ECC) and satisfactory colposcopy visualizing the complete transformation zone of the cervix.

• The patient will be available and in the San Diego area for 6 months after enrollment to complete the clinic visits and follow up.

Exclusion Criteria:

• Positive CIN 2-3 on ECC

• Presence of cancer

• Pregnancy or lactation

• Immuno-compromised (systemic lupus erythematosus, kidney transplant)

• Hepatitis

• Hypersensitivity to Imiquimod

• Ulcerative colitis

• Crohn's disease

• Human Immunodeficiency virus