ClinicalTrials.gg
RecruitingNCT03437005Updated Feb 20, 2026

Alternation in the Human Microbiome With Commonly Used Topical Medications

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

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Jan 2013, registered Feb 2018).
  • Started Jan 2013; still recruiting 13 years 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • Healthy

Keywords

  • Human microbiome
  • Topical
  • Steroid
  • Anti-fungal
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Desonide 0.05%

    Low potency steroid topical medication applied to specific locations on the face and extremities, twice daily for two weeks

    Drug: Desonide 0.05%

  • Experimental
    Ketoconazole 2%

    Antifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks

    Drug: Ketoconazole 2%

Interventions

  • Desonide 0.05% ointment topically twice daily for two weeks

  • Ketoconazole 2% cream topically twice daily for two weeks

06

What researchers measure

Primary outcomes

  1. Number of bacteria per each species

    Percentage of various bacteria present on each skin site

    Time frame: 2 weeks after initial dispensing

Secondary outcomes

  1. Number of species at test sites

    The taxonomic diversity and evenness of each skin site's microbiome

    Time frame: 2 weeks after initial dispensing

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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.

Registered
Feb 12, 2018
First posted
Feb 19, 2018
StartActual
Jan 28, 2013
Primary completionEst.
Sep 28, 2026
CompletionEst.
Sep 28, 2026
Last update
Feb 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437005
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Jan 28, 2013
Primary completion
Sep 28, 2026 (estimated)
Completion
Sep 28, 2026 (estimated)
Last update
Feb 20, 2026

Study contacts

Emanual Maverakis, MD
Contact
emaverakis@ucdavis.edu
916-734-8254
Lauren Downing
Contact
ldowning@ucdavis.edu
916-551-2635
Emanual Maverakis, MD
principal investigator · UC Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Desonide · Ketoconazole

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