Overview
Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis
Status:
Completed
Completed
Trial end date:
2018-12-20
2018-12-20
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Squarex, LLCTreatments:
Squaric acid dibutyl ester
Criteria
Inclusion Criteria:- Age ≥18
- Clinical diagnosis of herpes labialis, which may be made at the screening visit based
on the patient's self-reported history of symptoms. An active herpes labialis outbreak
at the time of entry into the clinical trial will neither be required nor will be an
exclusion criteria.
- Self report having four or more episodes of herpes labialis in the past 12 months
Exclusion Criteria:
- People that have had treatment with anti viral therapy within 2 weeks before
sensitization dose.
- 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.
- Therapy with glucocorticoid or immunosuppressants at time of recruitment or within
past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in
sites other than face.
- History of malignancy (except patients with surgically cured basal cell or squamous
cell skin cancers)
- History of organ transplantation
- HIV-positive status determined by history at screening or known history of any other
immunosuppressive disease.
- Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline
will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable
angina pectoris, oxygen-dependent severe pulmonary disease
- History of exposure to squaric acid or squaric acid dibutyl ester.
- Known hypersensitivity to DMSO
- Any condition judged by the investigator to cause this clinical trial to be
detrimental to the patient.
- Subject is currently enrolled in another investigational device or drug trial(s), or
subject has received other investigational agent(s) within 28 days of baseline visit.
- Previous or current participation in a clinical trial of SADBE to treat herpes
labialis.