Microneedling-assisted Panax ginseng exosome protocol for vulvovaginal symptoms and vulvar skin tone changes: A preliminary pilot observational study.

BackgroundNonhormonal approaches for vulvovaginal symptoms and vulvar skin concerns are increasingly being explored. However, clinical evidence for combined microneedling-assisted topical protocols in this setting remains limited.ObjectivesThis preliminary pilot observational study explored the short-term feasibility, patient-reported outcomes, tolerability, and qualitative photographic findings associated with a combined microneedling-assisted Panax ginseng exosome protocol with adjunctive inner gel use.DesignSingle-arm preliminary pilot observational study.MethodsFourteen women (mean age, 48.6 years; range, 24-63 years) underwent three treatment sessions at 2-week intervals, followed by a final assessment 2 weeks after the third treatment session, resulting in a total study duration of 6 weeks from baseline to final follow-up for each participant. Microneedling was performed on the vulvar area using a 2-mm dermaroller, followed by topical application of a Panax ginseng exosome formulation. Participants also used an adjunctive inner gel between visits. Outcomes included the Vulvovaginal Symptom Questionnaire (VSQ), the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, procedural pain assessed using a visual analogue scale (VAS), safety observations, and qualitative clinical photographic assessment.ResultsTotal VSQ score decreased after treatment (mean change, -2.86; 95% confidence interval [CI], -4.76 to -0.95; p = 0.00648). Total DIVA score also decreased (mean change, -5.43; 95% CI, -9.55 to -1.30; p = 0.0138), with significant improvement in the daily activities domain (median change, -2.0; p = 0.00849). The emotion and sexual life domains showed directional decreases but did not reach statistical significance. Procedure-related pain was transient and generally decreased within 30 minutes after treatment. Clinical photographs showed qualitative observational changes in pigmentation intensity and skin tone uniformity. No serious adverse events were observed during the short follow-up period.ConclusionThis small uncontrolled pilot study found that the combined microneedling-assisted Panax ginseng exosome protocol with adjunctive inner gel use was associated with short-term improvements in patient-reported vulvovaginal symptoms and qualitative vulvar skin tone observations. Because of the single-arm design, small sample size, combined intervention, subjective photographic assessment, and short follow-up, these findings should be interpreted as preliminary and hypothesis-generating.