Herpes SimplexNCT00642785
Activation of Alternative Cellular Energy (ACE) Pathway in the Therapy of Herpes Virus Infections
An observational study of Herpes Simplex and Herpes Zoster, run by Institute of Progressive Medicine.
Trial summary
The research question to be addressed is whether indirect phototherapy based activation of the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly inhibit both latent HSV infections and… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex, Herpes Zoster
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2008
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HSV and HZV infected patients
Who may be able to join
- Clinical diagnosis of active, latent or residual HSV or HZV infection
Who cannot join
- Unwilling or unable to provide Informed Consent
About this study
Official title: A Research Study Examining the Effectiveness of Distant Activation of ACE Pigments Associated With Recurrent Human Herpes Simplex Virus-Induced Skin Lesions.
The research question to be addressed is whether indirect phototherapy based activation of the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly inhibit both latent HSV infections and residual HZV infections.
- Conditions
- Herpes Simplex, Herpes Zoster
- Keywords
- herpes, HSV, zoster, HZV, shingles
- Medical subject headings
- Herpes Simplex, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with active oral or genital HSV skin lesions | |
| 2 | Patients with a history of recurrent oral or genital HSV but without an active lesion at the time of treatment | |
| 3 | Patients with active shingles/zoster | |
| 4 | Patients with post herpetic neuralgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expedited healing of active lesions
Measured: Within 1 day following therapy
Secondary outcomes (1)
Recurrence of lesions and/or symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes SimplexStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Progressive Medicine
- Sponsor type
- University, hospital or other
- Investigators
- W John Martin, MD, PhD, Principal investigator, Institute of Progressive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642785
- Sponsor's protocol ID
- 071/081
- Status last verified
- May 2008
- First submitted
- 19 Mar 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin WJ, Stoneburner J. Symptomatic relief of herpetic skin lesions utilizing an energy-based approach to healing. Exp Mol Pathol. 2005 Apr;78(2):131-4. doi: 10.1016/j.yexmp.2004.10.007. Epub 2005 Jan 5.
PubMed 15713438
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Research Study Examining the Effectiveness of Distant Activation of ACE Pigments Associated With Recurrent Human Herpes Simplex Virus-Induced Skin Lesions.
- ClinicalTrials.gov ID
- NCT00642785
- Acronym / sponsor ID
- 071/081
- Conditions
- Herpes Simplex, Herpes Zoster
- Keywords
- herpes, HSV, zoster, HZV, shingles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Progressive MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Mar 2008 (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.
The research question to be addressed is whether indirect phototherapy based activation of the body's alternative cellular energy (ACE) pathway will lead to expedited healing of active herpes simplex virus (HSV) and herpes zoster virus (HZV)skin lesions, and also possibly inhibit both latent HSV infections and residual HZV infections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with active oral or genital HSV skin lesions |
| 2 | – | –Patients with a history of recurrent oral or genital HSV but without an active lesion at the time of treatment |
| 3 | – | –Patients with active shingles/zoster |
| 4 | – | –Patients with post herpetic neuralgia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HSV and HZV infected patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of active, latent or residual HSV or HZV infection
Key exclusion criteria (1 listed)
- Unwilling or unable to provide Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Expedited healing of active lesions
Time frame: Within 1 day following therapy
1 secondary outcome
Recurrence of lesions and/or symptoms
Time frame: 3 months
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 3 Jun 2008.
- Background: PubMed 15713438Martin WJ, Stoneburner J. Symptomatic relief of herpetic skin lesions utilizing an energy-based approach to healing. Exp Mol Pathol. 2005 Apr;78(2):131-4. doi: 10.1016/j.yexmp.2004.10.007. Epub 2005 Jan 5.
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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.
W John Martin, MD, PhD principal investigator
Institute of Progressive Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Herpes Simplex and Herpes Zoster, run by Institute of Progressive Medicine.
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 1 inclusion and 1 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 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Expedited healing of active lesions (time frame: Within 1 day following therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642785, which also lists 1 linked publication.
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 3 Jun 2008.