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HealthyPhase 1NCT03437005

Alternation in the Human Microbiome With Commonly Used Topical Medications

A Phase 1 study testing Desonide 0.05% and Ketoconazole 2% in people with Healthy, run by University of California, Davis at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Desonide 0.05% and Ketoconazole 2%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
28 Jan 2013to 28 Sep 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emanual Maverakis, MD contact

916-734-8254

emaverakis@ucdavis.edu

Lauren Downing contact

916-551-2635

ldowning@ucdavis.edu

United States1 site, 1 recruiting
  • University of California, Davis, Department of Dermatology

    Sacramento, California, 95816

    Emanual Maverakis, MD, 916-734-8254, emaverakis@ucdavis.edu

    Lauren Downing, 916-551-2635, ldowning@ucdavis.edu

    Recruiting

Other trials in United States

About this study

Official title: Alterations in the Human Microbiome With Commonly Used Topical Medications

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.

Conditions
Healthy
Being tested
Desonide 0.05%, Ketoconazole 2%
Keywords
Human microbiome, Topical, Steroid, Anti-fungal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desonide 0.05%Drug

    Desonide 0.05% ointment topically twice daily for two weeks

  • Ketoconazole 2%Drug

    Ketoconazole 2% cream topically twice daily for two weeks

Study groups in NCT03437005
Study groupRoleWhat they receive
Desonide 0.05%ExperimentalLow potency steroid topical medication applied to specific locations on the face and extremities, twice daily for two weeks
Receives: Drug: Desonide 0.05%
Ketoconazole 2%ExperimentalAntifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks
Receives: Drug: Ketoconazole 2%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of bacteria per each species

    Percentage of various bacteria present on each skin site

    Measured: 2 weeks after initial dispensing

Secondary outcomes (1)
  1. Number of species at test sites

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

    Measured: 2 weeks after initial dispensing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start28 Jan 2013
  3. Primary completion28 Sep 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patient will be randomized to one of two groups, with one group receiving ketoconazole cream and the other receiving desonide ointment.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03437005
Sponsor's protocol ID
390406
Status last verified
Feb 2026
First submitted
12 Feb 2018
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Desonide 0.05% and Ketoconazole 2% in people with Healthy, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emanual Maverakis, MD (916-734-8254, emaverakis@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of bacteria per each species (time frame: 2 weeks after initial dispensing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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