A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis

NCT03521479 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: P2c
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Herpes Labialis; HSV

Keywords

Squaric Acid; SADBE; Squaric acid dibutyl ester

Outcome Measures

Primary Outcomes (1)

• Local and Generalized Adverse Events

  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).

  9 months

Study Arms (4)

Group A

EXPERIMENTAL

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.

Drug: Squaric Acid Dibutyl Ester

Group B

EXPERIMENTAL

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.

Drug: Squaric Acid Dibutyl Ester

Group C

ACTIVE COMPARATOR

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.

Drug: Squaric Acid Dibutyl Ester

Group D

ACTIVE COMPARATOR

Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.

Drug: Squaric Acid Dibutyl Ester

Interventions

Squaric Acid Dibutyl Ester DRUG

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).

Also known as: Repeat Dosing

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 65
• Self report having four (4) or more episodes of herpes labialis in the past 12 months.
• Subjects will NOT be told that four-or-more episodes in the previous 12 months is the entry criterion. Subjects will be asked "How many separate episodes of cold sores have you had in the previous 12 months?" They will be included if they give an answer of four or more and excluded if they give an answer of three or fewer.
• 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.

You may not qualify if:

• 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).
• History of organ transplantation.
• HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
• Severe co-morbidities (CHF \[NYHA class II or worse\], MI, CVA or TIA) within 3 months of screening visit, current unstable angina pectoris or oxygen-dependent severe pulmonary disease.
• Known hypersensitivity to Dimethyl sulfoxide (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 the screening visit.
• Previous exposure to SADBE (squaric acid or squaric acid dibutyl ester).
• Subject has an abnormal skin condition (e.g., acne, eczema, rosacea, psoriasis, albinism, or chronic vesiculo-bullous disorder) that occurs in the area ordinarily affected by herpes labialis
• Subject has an abnormal skin condition (e.g., eczema, rosacea, psoriasis, albinism, or chronic vesiculo-bullous disorder) that occurs in the inner aspect of either upper arm (the area where drug will be applied).
• Subject has had a vaccine for either HSV-1 or HSV-2.
• Subject has had treatment with anti-viral therapy (including ABREVA) within 2 weeks before first dose of SADBE or at any time during the study.

Sponsors & Collaborators

• Squarex, LLC: lead

Study Sites (2)

International Research Partners, LLC

Doral, Florida, 33166, United States

Location

Prism Clinical Research, LLC

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

squaric acid dibutyl ester

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Hugh McTavish
• Organization: Squarex LLC

hmctavish@squarex-pharma.com

6512078270

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The double-blinding only applies between groups A and B. Subjects for groups C and D will be recruited on an open label basis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive on a double blind basis one of two treatment regimens: * Group A: 15 subjects, treated with 2% SADBE on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8. * Group B: 15 subjects, treated with 2% SADBE on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8. And subjects will be recruited on an open label basis to two other treatment regimens: * Group C: 15 subjects, treated with 2% SADBE on day 0, month 3, and month 6. * Group D: 15 subjects, treated with 2% SADBE on day 0 and month 6.

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 11, 2018
• Study Start: March 12, 2018
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2019
• Last Updated: August 6, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)