FINAL CLINICAL TRIAL RESULTS FROM ‘THE PALOMA STUDY’
Papilocare Science Source: Serrano L, et al. “Efficacy of a Coriolus versicolor-Based Vaginal Gel in Women With Human Papillomavirus-Dependent Cervical Lesions: The PALOMA Study.” Journal of Lower Genital Tract Disease vol. 25,2 (2021): 130-136. doi:10.1097/LGT.0000000000000596
Repair of Cervical HPV-Induced Lesions (Primary Endpoint of Study)
The percentage of patients presenting with normal Pap smear findings and concordant colposcopy observations after 6 months was significantly higher in the treatment group than in the control group (84.9% vs 64.5%, p = .031), with this difference being even more noticeable in the High-risk HPV subgroup (87.8% vs 56.0% for the treatment and control groups, respectively, p = .003). Significant differences were also observed at 3 months in the total sample (78.0% vs 54.8% for the treatment and control groups, respectively, p = .023) and the HR HPV subgroup (79.5% vs 52.0%, p = .017).
Cervical Re-epithelization (A Secondary Endpoint of the Study)
The cervical re-epithelization score of the treated patients improved significantly between the baseline (mean = 4.2 [SD = 0.9]) and month 6 (mean = 4.5 [SD = 0.7], p = .001; see Figure 3). At the 6-month visit, the score was significantly higher among the patients of the treatment group compared with those of the control group (mean = 4.1 [SD = 0.9], p = .017). A trend toward a higher percentage of patients with no ectopy was observed with Papilocare (from 45.8% at baseline to 62.3% at 6 months) in comparison with the control group (from 37.5% to 35.5%). At the 3-month visit, significant differences were observed between the percentage of patients with no ectopy in the treatment group versus the control group (52.5% vs 40.6%, p = .013).