Topical Ketotifen 0.25% for Secondary Vestibulodynia

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Center for Vulvovaginal Disorders
Study ID
NCT07257029
Phase
PHASE2
Status
Recruiting
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Conditions

  • Instertional Dyspareunia
  • Mast Cell-mediated Neuroinflammation
  • Neuroproliferative Vestibulodynia
  • Provoked Vestibulodynia
  • Secondary Provoked Vestibulodynia
  • Vulvary Pain Disorders
  • Vulvodynia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketotifen Fumarate 0.25% Cream — DRUG
    Participants apply topical ketotifen fumarate 0.25% cream as a thin layer to the vulvar vestibule twice daily (approximately every 8-12 hours) for 12 weeks after completing the 2-week placebo run-in period. The cream is provided in pre-weighed tubes and used throughout the randomized treatment phase.
  • Placebo (Vehicle Cream) — DRUG
    Participants apply the matching vehicle cream as a thin layer to the vulvar vestibule twice daily (approximately every 8-12 hours) for 12 weeks following completion of the 2-week placebo run-in period. The placebo cream is identical in appearance and packaging to the ketotifen cream and is provided in pre-weighed tubes for use throughout the randomized treatment phase.

Study Details

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of topical ketotifen fumarate 0.25% cream in adult women with secondary provoked vestibulodynia (PVD). Secondary PVD is a chronic vulvar pain condition characterized by burning or sharp pain with vaginal penetration (e.g., intercourse, tampon use) and touch of the vulvar vestibule, often following recurrent infections or topical irritant exposures. Preclinical studies suggest that ketotifen, a mast-cell stabilizer and histamine H1 antagonist, may reduce neuroinflammation and abnormal nerve growth in the vulvar vestibule, offering a mechanism-based, non-surgical treatment option. Approximately 54 women aged 18 years and older who meet ISSVD/ISSWSH/IPPS criteria for secondary PVD without vulvovaginal atrophy will be enrolled. After a 1-week screening period, all participants will complete a 2-week single-blind placebo run-in; those with a strong placebo response or intolerance to vehicle cream will not be randomized. Eligible participants will then be randomized 1:1 to receive ketotifen fumarate 0.25% cream or matching placebo cream applied twice daily to the vulvar vestibule for 12 weeks. The primary outcome is change from baseline to Week 15 in pain intensity with the baseline dilator maximum tested size (DMTS), measured on an 11-point numeric rating scale. Secondary outcomes include changes in Vulvodynia Experience Questionnaire (VEQ) scores, vestibular pain thresholds measured by Wagner algometry, and participant-reported meaningful benefit at the end of treatment. Safety assessments will include adverse events, application-site reactions, physical examinations, vital signs, and pregnancy testing. This study will provide the first controlled clinical data on topical ketotifen for secondary PVD and inform the feasibility of larger registration trials.

Key Dates

Start date
Jan 2, 2026
Status verified
Nov 2025
Primary completion
Aug 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketotifen Fumarate 0.25% Cream
    Participants receive topical ketotifen fumarate 0.25% cream applied as a thin layer to the vulvar vestibule twice daily (approximately every 8-12 hours) for 12 weeks following completion of the 2-week placebo run-in period. The ketotifen cream is supplied in pre-weighed tubes and used for the full randomized treatment phase.
  • Placebo Comparator: Placebo (Vehicle Cream)
    Participants receive the matching vehicle cream applied as a thin layer to the vulvar vestibule twice daily (approximately every 8-12 hours) for 12 weeks following completion of the 2-week placebo run-in period. The placebo cream is identical in appearance and packaging to the active study cream and is supplied in pre-weighed tubes for the full randomized treatment phase.

Primary Outcome Measure

Change in Dilator-Induced Pain at the Baseline Dilator Maximum Tested Size (DMTS) [ Time Frame: Baseline to Week 15 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The Center for Vulvovaginal Disorders - Washington, DCWashington D.C.District of Columbia20037
Chailee Moss, MD
[email protected]
202-887-0568
The Center for Vulvovaginal DisordersTampaFlorida33609
Jill Krapf, MD
[email protected]
813-358-7634
The Center for Vulvovaginal Disorders - New YorkNew YorkNew York10036
Andrew T Goldstein, MD
[email protected]
410-279-0209

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The Center for Vulvovaginal Disorders - Washington, DC· Washington D.C., DCThe Center for Vulvovaginal Disorders· Tampa, FLThe Center for Vulvovaginal Disorders - New York· New York, NY

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