A Multi-center, Randomized, Double-blind, Placebo-controlled Trial of Topical Ketotifen Fumarate 0.25% Cream for Females With Secondary Vestibulodynia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of topical ketotifen fumarate 0.25% cream in adult women diagnosed with secondary provoked vestibulodynia (PVD), a chronic vulvar pain condition causing burning or sharp pain during vaginal penetration or touch. This Phase 2, multi-center, randomized, double-blind, placebo-controlled trial aims to explore a new non-surgical treatment option targeting neuroinflammation and abnormal nerve growth in the vulvar vestibule, conditions that currently lack FDA-approved pharmacologic therapies. Participants will first undergo a 1-week screening followed by a 2-week single-blind placebo run-in period. Those who do not respond strongly to placebo or have intolerance to the vehicle cream will be randomized in a 1:1 ratio to receive either ketotifen fumarate 0.25% cream or a matching placebo cream. Both creams are applied twice daily to the vulvar vestibule for 12 weeks. The study includes visits at baseline, Week 3 (randomization), Week 9, and Week 15, with a 30-day safety follow-up after treatment. Throughout the study, participants will complete pain and functional assessments including an 11-point pain rating scale during vaginal dilator testing, vulvodynia-specific questionnaires, and pressure pain threshold measurements. Researchers will monitor safety through physical exams, vital signs, pregnancy testing, and documentation of adverse events and local reactions. Study cream adherence is tracked via tube weights and self-reports. The primary outcome measures change in pain intensity at Week 15 compared to baseline, with secondary outcomes assessing quality of life, pain thresholds, and participant-reported meaningful benefit.

Topical Ketotifen 0.25% for Secondary Vestibulodynia