Clinical efficacy and safety of Capilliposide for cervical intraepithelial neoplasia with HR-HPV infection: a prospective, multicentre, single arm study

Cervical intraepithelial neoplasia (CIN), as precancerous lesions of cervical carcinoma, are closely linked to the prevalence and progression of cervical cancer. We conducted a prospective study of 81 participants with CIN 1/2/3 and HR-HPV infection and assessed the safety and efficacy of 1% Capilliposide B and Capilliposide C vaginal gel (CVG) for them. Group 1 received CVG intravaginally every other day for 4 weeks for preliminary safety evaluation. After confirming no significant side effects, Group 2 underwent a 12-week efficacy and safety evaluation. All participants returned in 3-6 months for HPV typing and Thinprep Cytologic Test (TCT) or further biopsy. Adverse event rates were 25% (2/8) in Group 1 and 30% (20/67) in Group 2. Complete regression was observed histologically in 70% of CIN 1 and 30% of CIN 2/3 participants. Based on TCT, 80% (36/45) of cervical lesions regressed to no intraepithelial lesion or malignancy (NILM). The HR-HPV clearance rate was 34.3%, with 72% (8/11) for HPV 16 and 60% (3/5) for HPV 18. CVG treatment was well tolerated. The self-administered CVG was found to be safe, tolerable, and effective for treating CIN 1/2/3 with HR-HPV.