A 20-Year-Old immune regulator faces its biggest test against cold sores
NCT ID NCT04065971
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether 2LHERP, an immune regulator available for over 20 years, can reduce the number of cold sore outbreaks in adults who get at least six per year. Participants take one capsule daily for six months, then researchers compare outbreak rates over a year against a placebo group. The goal is to see if 2LHERP can keep the herpes virus in check, though it cannot eliminate the virus entirely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 2LHERP, an immune regulator taken as one capsule daily for six months
- What this could lead to
- If effective, 2LHERP could offer a way to reduce the frequency of cold sore outbreaks, improving quality of life for people with recurrent herpes.
- What could go wrong
- This is a phase 4 trial with 140 participants, so results may not apply broadly. The treatment does not cure herpes, and its benefit over placebo is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Man or woman aged 16-80 years, * Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months' period (prior to the study entry), * Woman of childbearing age under effective contraception, * Patient reporting a current stable sexual relationship (steady sexual partner during study duration), * Patient having faculties to understand and respect the constraints of the study, * Signature of the Informed Consent Form. Exclusion Criteria: * Pregnant or breastfeeding woman, * Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, * Patient who had a suppressive antiviral therapy during last month, * Patient who wishes to continue his/her suppressive antiviral therapy, * Patient with known lactose intolerance, * Patient who participated in a clinical study in the previous 3-month period, * Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study, * Patient with severe immunodeficiency disease requiring long term treatment (\*) or under chemotherapy or radiotherapy or corticoid therapy, * Patient under listed homeopathic or phytotherapy treatment, * Patient using or addicted to recreational drugs. (\*) important renal or respiratory insufficiency, transplanted or grafted patients HIV/AIDS, terminal cancer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cabinet privé
RECRUITINGBeuzet, 5030, Belgium
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Cabinet privé
RECRUITINGNoirefontaine, 6831, Belgium
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Clinique Saint-Luc (Bouge)
RECRUITINGBouge, 5004, Belgium
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Private Practice
RECRUITINGBeerzel, 1650, Belgium
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Private Practice
RECRUITINGLinkebeek, 1630, Belgium
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Private Practice
RECRUITINGOisquercq, 1480, Belgium
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