Common ColdPhase 2NCT00993759
Efficacy Study of A Lotion to Prevent Common Colds
A Phase 2 study testing 3804-250A in people with Common Cold and Healthy, run by The Dial Corporation at 1 site in United States.
Trial summary
The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses. The study will also evaluate the safety of 3804-250A. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Healthy
- What is being tested?
- 3804-250A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2009
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Read and sign a copy of the approved Consent Form;
- 18-40 years of age;
- If a woman of child bearing potential (WOCBP) must have a negative urine pregnancy test and be using an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, vasectomized partner, abstinence, or condoms;
- Capable of compliance with the required study and sick visits (i.e., no planned travel commitments);
- Willing to follow study restrictions;
- Generally in good health based on medical history interview.
Who cannot join
- Current participation on any study;
- Participation in an investigational drug study within 30 days of enrollment;
- Participation within 30 days of enrollment on any study where the hands were the test site;
- Pregnancy (as determined by an urine pregnancy test), lactation or planning a pregnancy during the course of the study;
- Daily smoker;
- Current or significant history of sinusitis;
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- Skin conditions on the hands or wrists that would interfere with the evaluations, such as scars, tattoos, uneven skin tones, or other conditions;
- Allergy to soaps, detergents, preservatives, citric acid, malic acid or ethanol;
- Immunological disorders (i.e., AIDS, HIV, systemic lupus erythematosis, rheumatoid arthritis);
- Current use or use within 7 days prior to randomization of any antibacterial medications for treatment of respiratory infections;
- Current use or use within 7 days enrollment of topical drugs (e.g. hydrocortisone or other corticosteroids) to treat skin conditions on the hands or wrists, except for localized treatment of minor cuts or scrapes;
- Occupational or other requirement for unusually frequent hand washing (i.e. health care worker, food service worker);
- Currently suffering from respiratory allergies or a history of seasonal respiratory allergies that are normally active during the study period;
- History of dermatologic disease on the hands, wrists or arms;
- History of 3rd degree burns and/or skin grafts on the hands or wrists;
- History of significant or frequent skin and soft tissue infections;
- Use of androgens, immunomodulators (such as growth factors, systemic corticosteroids, immune globulin, interleukins, interferons) or immunosuppressive medications within 30 days prior to study entry.
- Erythema score of 1.0 and/or dryness scores on the hands at enrollment of greater than Grade 0;
- Subject does not experience colds;
- The subjects from TM\&R-0062-08-TXC who were discontinued for irritation, experienced test product related skin reactions or were withdrawn from the study or excluded from the per-protocol analysis for non-compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.
The study will also evaluate the safety of 3804-250A.
Read the detailed description
Rhinovirus infections are the most frequent cause of up to 80% of cold illness during the fall rhinovirus season. While viral upper respiratory tract infections are generally mild and self-limiting, they are associated with an enormous economic burden, both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.
Marketed treatment options for common colds consist primarily of symptomatic cold remedies that have only most effects on specific cold symptoms. 3804-250A is a topical treatment under investigation for the prevention of rhinovirus-associated colds by interruption of person-to-person transmission.
The study is a randomized trial conducted during a 9-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be randomly assigned to one of two treatment groups:
- AV Lotion or
- No Treatment control.
Subjects in the 3804-250A group will use the treatment on a defined schedule. The No Treatment control group will maintain their regular hand washing routine.
All subjects will record the presence of cold illness symptoms daily. Subjects will return to the study site weekly during the study for specimen collection for rhinovirus PCR, evaluation of irritation, review and clarification of study diary entries, for review and assessment of compliance, collection of adverse events and replenishment of study supplies. In addition, for the first five weeks of the study, subjects in the AV Lotion group will attend a second weekly compliance visits in which diaries and test product consumption will be assessed for compliance and collection of adverse events. Photographs of the hands will be taken for subjects who are withdrawn for skin irritation. The incidence of cold illness, rhinovirus-associated cold illness and rhinovirus infection will be compared between the treatment groups.
- Conditions
- Common Cold, Healthy
- Being tested
- 3804-250A
- Keywords
- common cold, rhinovirus, prevention
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3804-250ADrug
3.2 ml applied topically after hand washing and at least every 3 hours while awake.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Not described |
| 3804-250A lotion | Experimental | Not described Receives: Drug: 3804-250A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of rhinovirus-induced common colds.
Measured: 9 weeks
Secondary outcomes (1)
Reduction of rhinovirus infections and reduction of common colds.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dial Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hill Top Research
- Investigators
- Ronald Turner, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993759
- Sponsor's protocol ID
- TM&R-0108-09-TXC
- Status last verified
- Oct 2009
- First submitted
- 8 Oct 2009
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
PubMed 33215698Turner RB, Fuls JL, Rodgers ND, Goldfarb HB, Lockhart LK, Aust LB. A randomized trial of the efficacy of hand disinfection for prevention of rhinovirus infection. Clin Infect Dis. 2012 May;54(10):1422-6. doi: 10.1093/cid/cis201. Epub 2012 Mar 12.
PubMed 22412063
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
- ClinicalTrials.gov ID
- NCT00993759
- Acronym / sponsor ID
- TM&R-0108-09-TXC
- Conditions
- Common Cold, Healthy
- Keywords
- common cold, rhinovirus, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (actual)
- Lead sponsor
- The Dial CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Hill Top Research
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 12 Oct 2009 (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 purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.
The study will also evaluate the safety of 3804-250A.
Detailed description
Rhinovirus infections are the most frequent cause of up to 80% of cold illness during the fall rhinovirus season. While viral upper respiratory tract infections are generally mild and self-limiting, they are associated with an enormous economic burden, both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.
Marketed treatment options for common colds consist primarily of symptomatic cold remedies that have only most effects on specific cold symptoms. 3804-250A is a topical treatment under investigation for the prevention of rhinovirus-associated colds by interruption of person-to-person transmission.
The study is a randomized trial conducted during a 9-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be randomly assigned to one of two treatment groups:
- AV Lotion or
- No Treatment control.
Subjects in the 3804-250A group will use the treatment on a defined schedule. The No Treatment control group will maintain their regular hand washing routine.
All subjects will record the presence of cold illness symptoms daily. Subjects will return to the study site weekly during the study for specimen collection for rhinovirus PCR, evaluation of irritation, review and clarification of study diary entries, for review and assessment of compliance, collection of adverse events and replenishment of study supplies. In addition, for the first five weeks of the study, subjects in the AV Lotion group will attend a second weekly compliance visits in which diaries and test product consumption will be assessed for compliance and collection of adverse events. Photographs of the hands will be taken for subjects who are withdrawn for skin irritation. The incidence of cold illness, rhinovirus-associated cold illness and rhinovirus infection will be compared between the treatment groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | – |
| 3804-250A lotion | Experimental | Drug: 3804-250A |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Read and sign a copy of the approved Consent Form;
- 18-40 years of age;
- If a woman of child bearing potential (WOCBP) must have a negative urine pregnancy test and be using an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, vasectomized partner, abstinence, or condoms;
- Capable of compliance with the required study and sick visits (i.e., no planned travel commitments);
- Willing to follow study restrictions;
Key exclusion criteria (20 listed)
- Current participation on any study;
- Participation in an investigational drug study within 30 days of enrollment;
- Participation within 30 days of enrollment on any study where the hands were the test site;
- Pregnancy (as determined by an urine pregnancy test), lactation or planning a pregnancy during the course of the study;
- Daily smoker;
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 |
|---|---|---|
| 3804-250A3.2 ml applied topically after hand washing and at least every 3 hours while awake. | Drug | 3804-250A lotion |
Primary outcome
Reduction of rhinovirus-induced common colds.
Time frame: 9 weeks
1 secondary outcome
Reduction of rhinovirus infections and reduction of common colds.
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Derived from this study: PubMed 33215698Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
- Derived from this study: PubMed 22412063Turner RB, Fuls JL, Rodgers ND, Goldfarb HB, Lockhart LK, Aust LB. A randomized trial of the efficacy of hand disinfection for prevention of rhinovirus infection. Clin Infect Dis. 2012 May;54(10):1422-6. doi: 10.1093/cid/cis201. Epub 2012 Mar 12.
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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.
Ronald Turner, MD principal investigator
University of Virginia
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 3804-250A in people with Common Cold and Healthy, run by The Dial Corporation at 1 site in United States.
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 20 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: status not confirmed, as of the sponsor's last update on 12 Oct 2009. 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 United States. 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. 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?
Results are not available in the source record.
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?
Reduction of rhinovirus-induced common colds. (time frame: 9 weeks). 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 NCT00993759, which also lists 2 linked publications.
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 12 Oct 2009.