NCT01477879

Brief Summary

This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

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

January 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

November 15, 2011

Last Update Submit

November 19, 2011

Conditions

Herpes

Outcome Measures

Primary Outcomes (2)

  • Pain

    Pain scale-- subjective

    2 weeks

  • Size

    Measure lesion size over 2 weeks

    2 weeks

Secondary Outcomes (1)

  • Appearance

    2 weeks

Study Arms (2)

Versabase/20% S. purpurea extract

ACTIVE COMPARATOR
Other: Versabase gel with sarracenia purpurea 20% liquid extract

placebo (versabase gel only)

PLACEBO COMPARATOR

placebo used will be versabase gel alone

Other: placebo (versabase gel only)

Interventions

Versabase gel with sarracenia purpurea 20% liquid extractOTHER

Topical application of gel/plant mix to lesions

Versabase/20% S. purpurea extract
placebo (versabase gel only)OTHER

versabase gel only

placebo (versabase gel only)

Eligibility Criteria

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

You may qualify if:

  • \- Hsv 1\&2

You may not qualify if:

  • No active lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naturopaths international

Flagstaff, Arizona, 86001, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Brandie Gowey

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 23, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

US(1)