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Zinc for the Treatment of Herpes Simplex Labialis (HSL)

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ClinicalTrials.gov Identifier: NCT00809809
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborators:
Women's Health Services, Santa Fe, New Mexico
Southwest College of Naturopathic Medicine
Beth Israel Medical Center
Matrixx Initiatives, Inc.
Information provided by (Responsible Party):
Integrative Medicine Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Herpes Simplex Labialis
Interventions Drug: Zicam (Ionic zinc)
Drug: placebo
Enrollment 157
Recruitment Details Subjects were recruited at 3 medical clinics: Women's Health Services, Santa Fe, NM; Continuum Center, NYC, NY; SCNM medical Clinic, Scottsdale, Az
Pre-assignment Details Subjects were excluded if they had HSL for more than one day
Arm/Group Title Active Treatment Placebo Treatment
Hide Arm/Group Description Active medication - Zinc Swabs Placebo medication - Swabs identical to medication group
Period Title: Overall Study
Started 78 79
Completed 75 [1] 77 [2]
Not Completed 3 2
[1]
3 dropped from the study when it was discovered they met the exclusion criteria
[2]
2 dropped from the study when it was discovered they met the exclusion criteria
Arm/Group Title Active Treatment Placebo Treatment Total
Hide Arm/Group Description Active medication - Zinc Swabs Placebo medication - Swabs identical to medication group Total of all reporting groups
Overall Number of Baseline Participants 78 79 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
78
 100.0%
79
 100.0%
157
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 79 participants 157 participants
42.6  (11.8) 43.8  (12.5) 43.1  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
Female
60
  76.9%
62
  78.5%
122
  77.7%
Male
18
  23.1%
17
  21.5%
35
  22.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 78 participants 79 participants 157 participants
78 79 157
1.Primary Outcome
Title Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.
Hide Description Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects.
Arm/Group Title Active Treatment Placebo Treatment
Hide Arm/Group Description:
Active medication - Zinc Swabs
Placebo medication - Swabs identical to medication group
Overall Number of Participants Analyzed 61 73
Median (95% Confidence Interval)
Unit of Measure: Days to resolution
8
(0 to 16)
6
(0 to 21)
2.Secondary Outcome
Title Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.
Hide Description [Not Specified]
Time Frame 14 days
Outcome Measure Data Not Reported
Time Frame 14 days per subject
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Treatment Placebo Treatment
Hide Arm/Group Description Active medication - Zinc Swabs Placebo medication - Swabs identical to medication group
All-Cause Mortality
Active Treatment Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Treatment Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Treatment Placebo Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/79 (0.00%) 
There may have been differences between the populations in the different study sites that influenced the outcome of this clinical trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Riley, MD
Organization: Integrative Medicine Institute
Phone: 505 690-0688
Responsible Party: Integrative Medicine Institute
ClinicalTrials.gov Identifier: NCT00809809     History of Changes
Other Study ID Numbers: IMIZnc2008
First Submitted: December 15, 2008
First Posted: December 17, 2008
Results First Submitted: March 21, 2012
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014