Double-blinded study to evaluate microbiome and skin health using natural formula vs. topical chlorhexidine in dogs with superficial pyoderma and atopic dermatitis

The University of Florida College of Veterinary Medicine is currently recruiting dogs diagnosed with superficial pyoderma and atopic dermatitis for a clinical research study.

Enrollment Status: Closed- Not enrolling

Inclusion Criteria: Patients are eligible for the study when they:

a)  Are diagnosed with superficial pyoderma due to non-seasonal atopic dermatitis (AD)

b)  Are between 1 and 10 years of age

c)   Have another co-allergy associated with AD

d)  Are on allergen specific immunotherapy for <6 months or >1 year

Exclusion criteria: Patients will be excluded from the study if they:

a) Used systemic antibiotics in the last three months before each collection.

b) Received baths the day before each collection.

c) Have any other systemic or neoplastic diseases.

Immunomodulatory drugs such as glucocorticoids, cyclosporine, or oclacitinib, along with antihistamines or essential fatty acids, will be allowed to alleviate clinical signs during a crisis, only after collecting at least one skin sample. However, to standardize results, only one immunomodulatory drug will be permitted, without combinations and selected according to the dermatologist’s evaluation.

Treatment: Your dog will be randomly assigned to either the study treatment (natural formula) or the control group (chlorhexidine).

Enrolled dogs will be seen on day 0 (enrollment), 30 (end of the study), and 60 (4 weeks post treatment). At each visit, the dogs will undergo a clinical scoring. In addition, at each visit we will collect information on the “owner’s clinical assessment” i.e. if the treatment is working and if the treatment is easy to use. At each visit dogs will undergo skin barrier function evaluations including tests of skin hydration and pH. The tools used for these evaluations are non-invasive probes that are touched to the skin in 4 areas of the body including inguinal, axilla, pinnae, and the interdigital space of one paw .Finally, on day 0, 30, and 60, a sterile swab will be used to collect bacteria from the skin (axillae and abdomen) for the evaluation of the skin microbiome. In addition, at each visit washing fluid of six standardized skin areas (2.7 cm²) from ventral abdomen of enrolled dogs will be collected.

Costs: The study will pay for each visit, the dermatology exam, the natural formula, control (chlorhexidine), and microbiome and immunological evaluation associated with each visit. No other costs will be covered. 

Contact: You can contact our Small Animal Hospital at (352) 392-2235 to schedule an appointment with the Clinical Trial Team. Study Interest Form

PI: Dr. Domenico Santoro

Background: Skin allergies are very common in dogs. Allergic dogs have changes in the bacteria that normally live on the skin (aka bacterial flora). In particular, disease causing bacteria predominate and they may induce a worsening of allergies. Thus, the goal of the present study is to evaluate the effects of natural formula (commercially available in Brazil) vs. topical chlorhexidine in dogs with superficial pyoderma and allergies. The shampoo and lotion contain plant extracts proven to be efficacious against bacterial infections in dogs. The expectation is that this shampoo and lotion combination will be effective in treating the skin infection associated with allergies. In addition, we expect that the testing formula will modify the skin bacterial flora reducing the presence of disease-causing bacteria and increasing the percentage of beneficial bacteria.