Status:
UNKNOWN
Efficacy Study of A Lotion to Prevent Common Colds
Lead Sponsor:
The Dial Corporation
Collaborating Sponsors:
Hill Top Research
Conditions:
Common Cold
Healthy
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief 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 preven...
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, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT00993759
Start Date
August 1 2009
End Date
December 1 2009
Last Update
October 12 2009
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908