Introduction/Background Data on non-surgical treatment approaching cervical intraepithelial neoplasia (CIN) are scarce. Retrospective analysis suggest high efficacy of topical treatment with trichloroacetic acid (TCA). This study set out to investigate the efficacy of a single application of 85% TCA in the treatment of CIN I/II.

Methodology In this prospective phase II trial patients with CIN I/II were treated a single time with 85% TCA. After three and six months colposcopic, histologic and HPV evaluation was performed. The primary endpoint was treatment efficacy defined as complete histologic remission six months after treatment. The secondary endpoint was HPV clearance six months after treatment. Rates of histologic regression and remission and type specific HPV clearance three and six months after treatment are described.

Results A total of 102 patients with a median age of 26.6 (19.3–50.0) were included into this trial. Complete histologic remission rates were 75.5% (66.0 – 83.5%) and 78.4% (69.2 – 86.0%) three and six months after TCA treatment, respectively. The observed complete histologic remission rate is significantly higher than an expected spontaneous remission rate of 55% (p<0.001). Clearance rates of HPV 16, 18 and other high risk types were 76.5%, 91.7%, 68.7% after six months, respectively. Side effects of TCA were mild and lasted usually less than 30 minutes.

Conclusion This is the first prospective trial reporting high histologic complete remission rates in patients with CIN I/II after a single 85% TCA treatment. In the future, TCA may represent an effective and feasible non-surgical treatment approach for CIN.