NCT00297011

Brief Summary

A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

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

September 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 6, 2008

Status Verified

April 1, 2008

Enrollment Period

2.5 years

First QC Date

February 23, 2006

Last Update Submit

April 30, 2008

Conditions

Herpes Labialis

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is the maximum size of the primary lesion complex

Secondary Outcomes (1)

  • Secondary variables include: the proportion of primary lesions that are aborted; the mean time to healing of the primary lesion complex the frequency and mean duration of lesion pain among primary lesions; the frequency of secondary lesions

Interventions

valacyclovir+clobetasol gelDRUG

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older.
  • A history typical for recurrent herpes labialis. The subject must have experienced three or more cold sores in the last 12 months.
  • In general good health, without other serious medical conditions, as determined by the patient's account of his/her medical history.
  • Signature on the informed consent document.

You may not qualify if:

  • Patients who have participated in an investigational drug study in the four-week period prior to enrollment.
  • Previous herpes vaccine at any time.
  • Patients with major medical conditions such as chronic heart, pulmonary, renal or hepatic diseases.
  • Patients with immunodeficiency disorders such as HIV infection or cancer chemotherapy.
  • Patients using topical steroids on or near the face or systemic steroids within 30 days of enrollment.
  • Women who are pregnant, lactating or breast feeding.
  • Women of childbearing potential not using adequate contraception as judged by the Investigator.
  • Recent history of alcohol or drug abuse, which in the opinion of the investigator, may interfere with that study patient's compliance with study requirements.
  • Significant skin disease such as atopic dermatitis, acne, or rosacea that would interfere with the assessment of lesions.
  • Allergy or hypersensitivity to steroids, acyclovir, penciclovir and/or other nucleoside analogues.
  • Subjects with impaired renal function as defined as a serum creatinine above the upper limits of normal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Hull C, McKeough M, Sebastian K, Kriesel J, Spruance S. Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial. J Eur Acad Dermatol Venereol. 2009 Mar;23(3):263-7. doi: 10.1111/j.1468-3083.2008.03047.x. Epub 2009 Jan 8.

    PMID: 19143902DERIVED

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher Hull, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

September 1, 2004

Primary Completion

March 1, 2007

Study Completion

January 1, 2008

Last Updated

May 6, 2008

Record last verified: 2008-04

Locations

US(1)