Trial Outcomes & Findings for Zinc for the Treatment of Herpes Simplex Labialis (HSL) (NCT NCT00809809)
NCT ID: NCT00809809
Last Updated: 2014-01-08
Results Overview
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.
COMPLETED
PHASE3
157 participants
14 days
2014-01-08
Participant Flow
Subjects were recruited at 3 medical clinics: Women's Health Services, Santa Fe, NM; Continuum Center, NYC, NY; SCNM medical Clinic, Scottsdale, Az
Subjects were excluded if they had HSL for more than one day
Participant milestones
| Measure |
Active Treatment
Active medication - Zinc Swabs
|
Placebo Treatment
Placebo medication - Swabs identical to medication group
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
79
|
|
Overall Study
COMPLETED
|
75
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zinc for the Treatment of Herpes Simplex Labialis (HSL)
Baseline characteristics by cohort
| Measure |
Active Treatment
n=78 Participants
Active medication - Zinc Swabs
|
Placebo Treatment
n=79 Participants
Placebo medication - Swabs identical to medication group
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
79 participants
n=7 Participants
|
157 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: 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.
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.
Outcome measures
| Measure |
Active Treatment
n=61 Participants
Active medication - Zinc Swabs
|
Placebo Treatment
n=73 Participants
Placebo medication - Swabs identical to medication group
|
|---|---|---|
|
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.
|
8 Days to resolution
Interval 0.0 to 16.0
|
6 Days to resolution
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 14 daysOutcome measures
Outcome data not reported
Adverse Events
Active Treatment
Placebo Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place