Alterations in the Human Microbiome With Commonly Used Topical Medications

390406

The global aim of this study is to investigate how the human microbiome changes from baseline with commonly used topical medications such as topical antifungals, low to mid potency topical steroids and emollients. The specific aims are as follows: 1. Investigate whether ketoconazole cream, a commonly used topical antifungal, causes alterations in the human skin microbiome with short-term use. 2. Investigate whether desonide 0.05 % ointment, a commonly used low potency topical steroid, alters the human microbiome with short-term use.

2013-01-28

2026-09-28

2026-09-28

Recruiting

Early phase I

24

The inclusion criteria: • Adults at least 18 years of age. The exclusion criteria: * Individuals with known chronically active skin diseases, including atopic dermatitis, psoriasis, seborrheic dermatitis, other autoimmune and inflammatory skin conditions. * Patients with a history of skin cancer, multiple nevi, or other isolated lesions will not be excluded. * Individuals who have used topical, intravenous, intramuscular, or oral antibiotics within the last 6 months * Individuals with known allergies to any of the study medications. * Individuals younger than 18 years of age. * Adults unable to consent * Non-English speaking individuals. Given the complexity in the instructions that subjects will need to follow for proper sample collection, we will not seek to recruit non-English speaking individuals for this pilot study. * Prisoners

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patient will be randomized to one of two groups, with one group receiving ketoconazole cream and the other receiving desonide ointment.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Investigator and subject will be blinded.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-01-23