A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herp… (NCT03521479) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
Stopped: Study drug out of specification
United States40 participantsStarted 2018-03-12
Plain-language summary
Primary Objective: To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and ≤ 65
Exclusion criteria
✕. Self report having four (4) or more episodes of herpes labialis in the past 12 months.
✕. At least half of the subject's episodes of the previous 12 months should be vesicular in nature and at least half preceded by prodromal symptoms. Prodromal symptoms may include tingling, itching, burning or pain before the development of a herpetic lesion.
✕. Pregnant or lactating females.
✕. Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection in the last 12 months.
✕. Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks prior to the screening visit, or at any time during the study (including inhaled corticosteroids for asthma), except for topical steroids in sites other than face.
✕. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers).