Herpes LabialisPhase 2NCT02207881
A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
A Phase 2 study testing VDO gel in people with Herpes Labialis, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial summary
Recurrent herpes labialis are usually a minor malady of limited duration, although they are often painful and are uniformly discomforting for patients. Oral antivirals represent an advance in the treatment of recurrent herpes labialis, but the clinical implications are modest. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- VDO gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Recurrent herpes labialis are usually a minor malady of limited duration, although they are often painful and are uniformly discomforting for patients. Oral antivirals represent an advance in the treatment of recurrent herpes labialis, but the clinical implications are modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the duration of lesion episodes and pain by approximately one day. In recurrent HSV infections including herpes labialis, many instances of viral re-activation occur without symptoms, and can only be identified by detection of virus on the lips of infected individuals. In these cases, the virus is cleared from the local site without the development of a classical ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly stops viral replication in the skin and also causes the development of the herpes lesion prodrome and a considerable part of the symptoms associated with a classical ulcerative herpes lesion. One could therefore predict that treatment with an antiviral drug alone would help the immune system in shortening the virus replication, but may not substantially reduce the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related symptoms associated with the infection has been well established. We have found that a topical formulation of VDO is useful for alleviating pain and inflammation associated with infection caused by herpes virus.
Read the 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.
- Conditions
- Herpes Labialis
- Being tested
- VDO gel, placebo
- Keywords
- herpes labialis, cold sore
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VDO gelDrug
Also called RMN3001
VDO gel
placeboDrug
Also called RMN3001 placebo
matching placebo gel
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo gel, 25mg, 3 times up to 10 days Receives: Drug: placebo |
| VDO gel | Experimental | VDO gel 25mg, 3 times a day up to 10 days Receives: Drug: VDO gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Incidences of adverse event
Measured: at the end of treatment (up to 10 days)
Secondary outcomes (1)
the duration and severity of pain
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」
Measured: At the end of treatment (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Sponsor
- Investigators
- HUNG-MING WU, MD, PhD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207881
- Sponsor's protocol ID
- YSP-RMN3001-01
- Status last verified
- Jul 2014
- First submitted
- 31 Jul 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Topical VDO for the Treatment of Herpes Simplex Labialis
- ClinicalTrials.gov ID
- NCT02207881
- Acronym / sponsor ID
- YSP-RMN3001-01
- Conditions
- Herpes Labialis
- Keywords
- herpes labialis, cold sore
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Changhua Christian Hospital
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent herpes labialis are usually a minor malady of limited duration, although they are often painful and are uniformly discomforting for patients. Oral antivirals represent an advance in the treatment of recurrent herpes labialis, but the clinical implications are modest. Randomized, controlled clinical trials have shown that oral antivirals decrease the duration of lesion episodes and pain by approximately one day. In recurrent HSV infections including herpes labialis, many instances of viral re-activation occur without symptoms, and can only be identified by detection of virus on the lips of infected individuals. In these cases, the virus is cleared from the local site without the development of a classical ulcerative herpes lesion. In the other cases, the triggered specific immune response rapidly stops viral replication in the skin and also causes the development of the herpes lesion prodrome and a considerable part of the symptoms associated with a classical ulcerative herpes lesion. One could therefore predict that treatment with an antiviral drug alone would help the immune system in shortening the virus replication, but may not substantially reduce the disfiguring symptoms caused by the immune reaction. In dermatology, the principle of using an anti-inflammatory drug improve clinical outcomes by reducing inflammation-related symptoms associated with the infection has been well established. We have found that a topical formulation of VDO is useful for alleviating pain and inflammation associated with infection caused by herpes virus.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo gel, 25mg, 3 times up to 10 days |
| VDO gel | Experimental | Drug: VDO gelVDO gel 25mg, 3 times a day up to 10 days |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VDO gelAlso: RMN3001VDO gel | Drug | VDO gel |
| placeboAlso: RMN3001 placebomatching placebo gel | Drug | placebo |
Primary outcome
Adverse event
Time frame: at the end of treatment (up to 10 days)
Incidences of adverse event
1 secondary outcome
the duration and severity of pain
Time frame: At the end of treatment (up to 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HUNG-MING WU, MD, PhD principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VDO gel in people with Herpes Labialis, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: at the end of treatment (up to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.