- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02207881
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
Study Overview
Detailed Description
In the treatment of oral herpes labialis, it is desirable to have local absorption of the drug to provide pain relief directly at the lesion sites while minimizing overall exposure.
The present study is designed to elucidate the effects of VDO ( on recurrent herpes simplex labialis.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Changhua, Taiwan
- Changhua Christian Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female in the age group 20 to 75 years old.
- History of recurrent herpes labialis with at least one recurrence occurred during the past twenty-four months.
- Onset of prodrome, erythema or vesicle within 72 hours of initiation of treatment with the study drug.
- Subjects with previous herpes simplex labialis episodes must be healed for at least 14 days before the baseline.
- Must be willing and able to participate and to provide written informed consent.
- Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
Exclusion Criteria:
- Women during pregnancy, lactation or breastfeeding.
- Subjects using topical steroids on or near the face or systemic (oral, intravenous) steroids within 7 days prior to study drug administration; use of inhaled or nasal spray steroids does not exclude a subject from the study.
- Subjects have used anti-viral agents or NSAID in the preceding 7 days.
- Subjects are unwilling to stop for using topical medical, OTC, cosmetic or facial skin care products in or around the oral area during the study period.
- Subjects with immunodeficiency disorders such as human immunodeficiency virus (HIV) infection or receiving cancer chemotherapy.
- Subjects who have a history of hypersensitivity to diclofenac, lidocaine or propylene glycol.
- Subjects who have a known hypersensitivity to local anesthetics of the amide type, diclofenac, aspirin, or other NSAIDs.
- Subjects who are taking antiarrhythmics drug during screening visit;
- Subjects who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Subjects who use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery within 6 months before the study drug using.
- Subjects have history of substance abuse or psychiatric illness that would preclude compliance with the protocol.
- Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the investigator(s), would compromise the subject's participation in the study (including clinically significant dehydration or unstable vital signs).
- Subjects taking or having taken any other experimental drugs, drugs not approved in Taiwan, or participating in or having participated in other clinical studies in the 30 days prior to this clinical trial.
- Subjects who are considered unreliable as to medication compliance or adherence to scheduled appointments, or inappropriate for inclusion determined by the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
placebo gel, 25mg, 3 times up to 10 days
|
matching placebo gel
Other Names:
|
EXPERIMENTAL: VDO gel
VDO gel 25mg, 3 times a day up to 10 days
|
VDO gel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event
Time Frame: at the end of treatment (up to 10 days)
|
Incidences of adverse event
|
at the end of treatment (up to 10 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the duration and severity of pain
Time Frame: At the end of treatment (up to 10 days)
|
Pain intensity will be measured at baseline and in the Subject's DRC on a daily basis while receiving study drug until end of study. Pain and itching assessments will be using a Visual Analogue Scale (VAS) ranging 0 (no pain/itching) to 10 (the worst pain/itching imaginable). The subject will be asked the following question exactly as follows:「On a scale 1 to 10 where 0 means on pain/itching, and 10 means the worst possible pain/itching, rate the worst pain/itching that you have since last assessment」 |
At the end of treatment (up to 10 days)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: HUNG-MING WU, MD, PhD, Changhua Christian Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YSP-RMN3001-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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