A Phase 1 interventional study of Desonide 0.05% and Ketoconazole 2% in Healthy, sponsored by University of California, Davis. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by University of California, Davis · Phase 1, Interventional, and Basic science
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:
The microorganisms present on human skin influence human health and disease. Older methods of studying the skin microbiota, such as culture based techniques, favored bacteria, which readily grew under standard laboratory conditions, compared to current molecular approaches, which have shown a greater diversity of skin microbiota. Human skin is a large organ that contains a wide range of physiological and topographical diversity. Distinct niches exist which predispose certain areas, such as hairy, moist underarms to a different bacterial community from dry, smooth sites, such as forearms. Given that the skin is a critical barrier between the body's internal environment and the external environment, characterization of the microbiota of the skin may provide insight into the balance between skin health and disease.
Certain inflammatory skin diseases, such as seborrheic dermatitis, atopic dermatitis and psoriasis, have characteristic sites of involvement. The NIH funded Human Microbiome Project (HMP) aims to characterize the human microbiota and its role in health and disease. Recent research by the HMP showed that certain sites, such as the antecubital and popliteal fossa, sites commonly affected in atopic dermatitis, shared similar groups of organisms and distinct microbial communities. Sebaceous sites, commonly affected in seborrheic dermatitis, also shared similar microbial communities. In addition, Kong et al., showed that changes in microbial communities were temporally associated with disease flares in atopic dermatitis patients. Changes in the microbial communities in atopic dermatitis patients were not only associated with disease flares, but were also associated with whether the patient received treatment with topical medications, including antimicrobial or anti-inflammatory medications, during flares. These findings suggest that communities of microbes are important in the initiation and perpetuation of certain skin diseases and that the topical medications used in treatment of these diseases have an important role, which may be related to their alteration of the microbiome.
The most commonly used treatments in dermatology include topical steroids and topical antifungals, which have long established safety and efficacy. Understanding the changes that these topical medications cause in the human microbiome will provide further insight into their role in the treatment of certain skin diseases and may assist us in developing new therapies in the future.
University of California, Davis is the lead sponsor of 809 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria:
The exclusion criteria:
Individuals with known chronically active skin diseases, including atopic dermatitis, psoriasis, seborrheic dermatitis, other and inflammatory skin conditions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low potency steroid topical medication applied to specific locations on the face and extremities, twice daily for two weeks
Drug: Desonide 0.05%
Antifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks
Drug: Ketoconazole 2%
Desonide 0.05% ointment topically twice daily for two weeks
Ketoconazole 2% cream topically twice daily for two weeks
Number of bacteria per each species
Percentage of various bacteria present on each skin site
Time frame: 2 weeks after initial dispensing
Number of species at test sites
The taxonomic diversity and evenness of each skin site's microbiome
Time frame: 2 weeks after initial dispensing
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2013 (actual). Primary completion is estimated for Sep 2026, 164 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Desonide · Ketoconazole
University of California, Davis →