- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993759
Efficacy Study of A Lotion to Prevent Common Colds
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.
Study Overview
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 Photographs of the hands will be taken for subjects who are withdrawn for skin irritation.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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No treatment
|
|
EXPERIMENTAL: 3804-250A lotion
|
3.2 ml applied topically after hand washing and at least every 3 hours while awake.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of rhinovirus-induced common colds.
Time Frame: 9 weeks
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of rhinovirus infections and reduction of common colds.
Time Frame: 9 weeks
|
9 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Turner 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- TM&R-0108-09-TXC
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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