Herpes Labialis Clinical Trial
Official title:
A Randomized, Clinician-Blind, Clinical Study to Examine the Safety and Performance of Compeed© Total Careā¢ Cold Sore Patch With Zinc Sulfate for the Treatment of Herpes Labialis
If a person qualifies to participate in this study, they will have an equal chance of being
assigned to either of two groups. One group will receive a patch that they will need to
carry with them, because as soon as a cold sore starts (within 1 hour) they will need to put
the patch over the sore. The other group will not get a patch, but will need to follow the
other instructions anyway.
When a subject's outbreak begins, they will need to return to the study center within 24
hours. Then they will return according to the appointments given within 10 days. If the
study staff sees that their sore has healed enough before 10 days, subjects will be told
that they don't need to return again.
As long as subjects are in the study, they will need to answer a few simple questions every
day on a card or booklet called a diary, starting the first day of their outbreak. If a
subject is assigned to the patch group, they must wear the patch all the time, taking it off
only to replace it (if it gets loose, dirty, or unsightly) and at the study center, when
they are asked to remove the patch so the sore can be checked.
During the study subjects will be allowed to use paracetamol for pain, but no other
treatments or medicine. If they use paracetamol, subjects must record it in their diary. The
study will be stopped, and there will be no subject visits or treatments during the end of
year holiday break. If a subject experiences an outbreak during the holiday, they may follow
their usual treatment routine.
This is a two-arm, randomized, clinician-blind study. No severe adverse effects are expected
to be experienced in the control group. All subjects are allowed to treat cold sore related
pain with an oral analgesic - paracetamol (APAP). The use of APAP for pain will be recorded
as a concomitant medication. However, subjects will be required to refrain from using any
additional treatment (topical or systemic) during study participation.
Subjects randomized to treatment will be instructed to initiate the therapy within 1 hour
onset of their first sign or symptom and record their assessment in the diary card (for no
treatment subjects, they will only record assessments upon onset of first sign or symptom).
All subjects will return to the study center for clinical assessments within 24 hours and 48
hours after onset of first sign or symptom/initiation of treatment and every other day
thereafter, with a final visit at Day 10 or at the time of completion/discontinuation if
before Day 10. Diaries will be completed each day, beginning upon initiation of therapy (Day
0) and continuing until study completion/discontinuation, and will include information on
study product applications.
Subjects assigned to a patch treatment will wear a patch continuously on their lesion and
will apply a new patch on occasions where the patch becomes loose, falls off or becomes
unsightly, including at study visits to the facility where subjects will be asked to remove
their patch for clinical assessments. Treatment will continue until the lesion is healed,
for a maximum of 10 days. As the test period will possibly extend through the end of year
holiday break, subject visits and treatments will be halted during this break. All subjects
who have not initiated therapy including subjects assigned no treatment group, will be
allowed to use their regular therapy for a cold sore outbreak during the holiday break.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02483182 -
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
|
Phase 2 | |
Completed |
NCT00297011 -
Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis
|
Phase 2 | |
Completed |
NCT03310294 -
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes Labialis
|
N/A | |
Terminated |
NCT04539483 -
Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection
|
Phase 2 | |
Completed |
NCT02265913 -
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
|
Phase 3 | |
Completed |
NCT01971385 -
Safety and Efficacy of Squaric Acid Dibutyl Ester for the Treatment of Herpes Labialis
|
Phase 1 | |
Active, not recruiting |
NCT01695187 -
NB-001 Treatment of Recurrent Herpes Labialis
|
Phase 3 | |
Completed |
NCT00375570 -
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
|
Phase 3 | |
Completed |
NCT02871492 -
Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
|
Phase 2 | |
Completed |
NCT00769314 -
Phase 3 Clinical Study for the Treatment of Cold Sore
|
Phase 3 | |
Completed |
NCT00878072 -
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
|
Phase 2/Phase 3 | |
Completed |
NCT01574612 -
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
|
Phase 3 | |
Completed |
NCT03661541 -
Immune Response and General Immune Health in Subjects Infected With Herpes Simplex Virus Type 1 (HSV-1)
|
Phase 1 | |
Recruiting |
NCT01306084 -
Viral Infections in Healthy and Immunocompromised Hosts
|
||
Terminated |
NCT03521479 -
A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
|
Phase 2 | |
Terminated |
NCT00913692 -
A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis
|
Phase 2 | |
Completed |
NCT02207881 -
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
|
Phase 2 | |
Completed |
NCT01653509 -
An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
|
Phase 1 | |
Completed |
NCT00361881 -
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
|
Phase 3 | |
Recruiting |
NCT02582086 -
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
|
N/A |