Efficacy Study of A Lotion to Prevent Common Colds

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by The Dial Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hill Top Research
Information provided by:
The Dial Corporation
ClinicalTrials.gov Identifier:
NCT00993759
First received: October 8, 2009
Last updated: October 9, 2009
Last verified: October 2009

October 8, 2009
October 9, 2009
August 2009
November 2009   (final data collection date for primary outcome measure)
Reduction of rhinovirus-induced common colds. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993759 on ClinicalTrials.gov Archive Site
Reduction of rhinovirus infections and reduction of common colds. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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:

  1. AV Lotion or
  2. 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Common Cold
  • Healthy
Drug: 3804-250A
3.2 ml applied topically after hand washing and at least every 3 hours while awake.
  • No Intervention: No treatment
  • Experimental: 3804-250A lotion
    Intervention: Drug: 3804-250A
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
December 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993759
TM&R-0108-09-TXC
No
Leslie Lockhart, PhD / Principal Scientist, The Dial Corporation, A Henkel Company
The Dial Corporation
Hill Top Research
Principal Investigator: Ronald Turner, MD University of Virginia
The Dial Corporation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP