NCT01971385

Brief Summary

Subjects with a history of recurrent herpes labialis will be sensitized with either 2% SADBE or placebo. Following this, subjects sensitized with 2% SADBE will received.2% sqauric acid or.5% squaric acid on their cold sore within 72 hours of a recurrence. Subjects sensitized with placebo solution will receive placebo solution on their cold sore within 72 hours of a recurrence. Subjects will be followed for up to 6 mos after application of study medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.9 years

First QC Date

October 17, 2013

Results QC Date

March 23, 2017

Last Update Submit

May 5, 2017

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

  • Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization

    Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff

    8 months

Secondary Outcomes (1)

  • Number of Adverse Events Reported

    8 months

Study Arms (2)

2% Squaric Acid Sensitization

ACTIVE COMPARATOR

2% Squaric Acid solution will be applied for sensitization to the inner arm.

Drug: Squaric Acid solution

Placebo Solution

PLACEBO COMPARATOR

Patients in placebo group will be given dimethyl sulfoxide.

Drug: Placebo solution

Interventions

Squaric Acid solutionDRUG
Also known as: Squaric Acid Dibutyl Ester solution, SADBE
2% Squaric Acid Sensitization
Placebo solutionDRUG
Placebo Solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18
  • With clinical diagnosis of herpes labialis.
  • who self report having six or more episodes of herpes labialis in the previous 12 months.

You may not qualify if:

  • Pregnant or lactating females.
  • Current or recurrent 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 immunosuppressant at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma.
  • History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
  • History of organ transplantation
  • Negative HIV-positive status determined by history at screening or known history of any other immuno-suppressing disease.
  • 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.
  • Subjects who have known hypersensitivity to Squaric acid or any of its components.
  • History of recent alcohol or substance abuse (\< 1 year)
  • Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
  • History of psychiatric disease that would interfere with the patient's ability to comply with the study protocol
  • History of non-compliance with other therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

squaric acid dibutyl ester

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Maria Alora-Palli
Organization
Massachusetts General Hospital
mpalli@mgh.harvard.edu
6177265066

Study Officials

  • Alexandra B Kimball, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Unit for Research Trials in Skin

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 29, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 2, 2017

Results First Posted

October 2, 2017

Record last verified: 2017-05

Locations

US(1)