CompletedNCT02965781P2aUpdated Nov 2, 2021Results posted

Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

A Phase 1/2 interventional study of SADBE and Placebo in Herpes Labialis and Cold Sore, sponsored by Squarex, LLC. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-02.

Sponsored by Squarex, LLC · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 139
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Herpes Labialis
Cold Sore

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In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 139 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Squarex, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 139 participants (actual)

Study arms

Active comparator
One SADBE application
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.
Drug: SADBE · Other: Placebo
Active comparator
Two SADBE applications
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.
Drug: SADBE
Placebo comparator
Placebo application (DMSO only-No SADBE)
Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.
Other: Placebo

Interventions

DrugSADBE
Topical solution
Also known as: Squaric acid dibutyl ester
OtherPlacebo
Topical solution
Also known as: Vehicle-DMSO

What researchers measure

Primary outcomes

Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose
Time frame: 43 - 121 days after the first dose

Secondary outcomes

Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months
The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose
Time frame: From day 43 after the first dose up to 12 months

Results

Posted Nov 2, 2021

Participant flow

Participant flow — Overall Study
Milestone	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)
Started	46	46	47
Completed	46	46	47
Not completed	0	0	0

Outcome measures

PrimaryDays to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose

The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose

Time frame:: 43 - 121 days after the first dose
Reported as:: Median · days

Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
days	Placebo Application (DMSO Only-No SADBE)	Two SADBE Applications	One SADBE Application
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose	128 (4 to 318)	163 (7 to 318)	174 (17 to 318)

SecondaryNumber of Outbreaks Beginning 43 Days After the First Dose up to 12 Months

The number of new herpes labialis episodes per subject during the 12-month follow up period following the first drug dose, beginning day 43 after the first dose

Time frame:: From day 43 after the first dose up to 12 months
Reported as:: Mean · outbreaks per participant

Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months
outbreaks per participant	Placebo Application (DMSO Only-No SADBE)	Two SADBE Applications	One SADBE Application
Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months	0.610 ± 0.802	0.500 ± 0.849	0.231 ± 0.427

Adverse events

Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Application (DMSO Only-No SADBE)	0/47 (0%)	0/47 (0%)	17/47 (36.2%)
Two SADBE Applications	0/46 (0%)	0/46 (0%)	19/46 (41.3%)
One SADBE Application	0/46 (0%)	0/46 (0%)	18/46 (39.1%)

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Placebo Application (DMSO Only-No SADBE)	Two SADBE Applications	One SADBE Application
Erythema, stain, or rash at application siteSkin and subcutaneous tissue disorders	4/47	7/46	6/46
Irritation, itching at application siteSkin and subcutaneous tissue disorders	1/47	3/46	4/46
Tingling, stinging at application siteSkin and subcutaneous tissue disorders	4/47	0/46	0/46
Tingling distal from application siteSkin and subcutaneous tissue disorders	3/47	1/46	0/46
Flushed burning sensation on faceSkin and subcutaneous tissue disorders	0/47	1/46	2/46
Dermatitis from adhesiveSkin and subcutaneous tissue disorders	2/47	0/46	0/46
Dead skin at application siteSkin and subcutaneous tissue disorders	0/47	0/46	1/46
Dermatitis at application siteSkin and subcutaneous tissue disorders	0/47	1/46	1/46
Erythema distal from application siteSkin and subcutaneous tissue disorders	0/47	1/46	0/46
Herpes lesion on genitals, anus, or spineSkin and subcutaneous tissue disorders	1/47	1/46	1/46

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
<=18 years	0	0	0	0
Between 18 and 65 years	46	46	47	139
>=65 years	0	0	0	0

Age, Continuous
Age, Continuous(years)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Median	47.8 (19.8 to 82.6)	44.2 (23.8 to 80.4)	50.1 (21.1 to 82.6)	47.1 (19.8 to 82.6)

Sex: Female, Male
Sex: Female, Male(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Female	31	28	26	85
Male	15	18	21	54

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Asian	1	2	1	4
Black	11	7	8	26
Hispanic	13	18	17	48
White	21	18	21	60
Unasnswered	0	1	0	1

Region of Enrollment
Region of Enrollment(participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
United States	46	46	47	139

HSV-1-neg / HSV-2 neg
HSV-1-neg / HSV-2 neg(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Count of participants	1	2	3	6

HSV-1-neg / HSV-2 pos
HSV-1-neg / HSV-2 pos(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Count of participants	1	3	5	9

HSV-1-pos / HSV-2 neg
HSV-1-pos / HSV-2 neg(Participants)	One SADBE Application	Two SADBE Applications	Placebo Application (DMSO Only-No SADBE)	Total
Count of participants	30	19	24	73

4 further baseline measures are reported on the registry.

Study locations

5 sites

Stanford Medicine Outpatient Center
Redwood City, California 94063, United States
International Research Partners, LLC
Doral, Florida 33166, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Quality Clinical Research, Inc
Omaha, Nebraska 68114, United States
Advantage Clinical Trials
Bronx, New York 10468, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 16, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02965781
Lead sponsor: Squarex, LLC
Responsible party: Sponsor
First posted: Nov 17, 2016
Start date: Dec 2016
Primary completion: Dec 20, 2018
Completion: Dec 20, 2018
Results posted: Nov 2, 2021
Last update: Nov 2, 2021

Study contacts

Hugh McTavish, PhD, JD

study director · Squarex, LLC

Thomas D Horn, MD

study chair · Squarex, LLC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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