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Mast Cell Treatment in Post-tick Bite Illness (PTBI)

NCT07526558
Conditions
Post-tick Bite Illness, Mast Cell Stabilizer
Interventions
Ketotifen, fexofenadine, Cromolyn Sodium
Drug
Lead sponsor
University of North Carolina, Chapel Hill
Other
Eligibility
21 Years to 65 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Conditions
Provoked Vestibulodynia, Secondary Provoked Vestibulodynia, Vulvodynia, Vulvary Pain Disorders, Neuroproliferative Vestibulodynia, Mast Cell-mediated Neuroinflammation, Instertional Dyspareunia
Interventions
Ketotifen Fumarate 0.25% Cream, Placebo (Vehicle Cream)
Drug
Lead sponsor
Center for Vulvovaginal Disorders
Other
Eligibility
18 Years and older · Female only
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
3
States / cities
Washington D.C., District of Columbia • Tampa, Florida • New York, New York
Conditions
Fibromyalgia
Interventions
Ketotifen, Placebo (Sugar Pill)
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years to 65 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
1
States / cities
Indianapolis, Indiana