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.
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.
United States1 site, 1 recruiting
- 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
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:
- Investigate whether ketoconazole cream, a commonly used topical antifungal, causes alterations in the human skin microbiome with short-term use.
- 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 group | Role | What they receive |
|---|---|---|
| Desonide 0.05% | Experimental | Low 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% | Experimental | Antifungal 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.
Number of bacteria per each species
Percentage of various bacteria present on each skin site
Measured: 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
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.
- First posted19 Feb 2018
- Study start28 Jan 2013
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanual Maverakis, MD, Principal investigator, UC Davis
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in the Human Microbiome With Commonly Used Topical Medications
- ClinicalTrials.gov ID
- NCT03437005
- Acronym / sponsor ID
- 390406
- Conditions
- Healthy
- Keywords
- Human microbiome, Topical, Steroid, Anti-fungal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate whether ketoconazole cream, a commonly used topical antifungal, causes alterations in the human skin microbiome with short-term use.
- Investigate whether desonide 0.05 % ointment, a commonly used low potency topical steroid, alters the human microbiome with short-term use.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The patient will be randomized to one of two groups, with one group receiving ketoconazole cream and the other receiving desonide ointment.
| Arm | Type | Receives |
|---|---|---|
| Desonide 0.05% | Experimental | Drug: Desonide 0.05%Low potency steroid topical medication applied to specific locations on the face and extremities, twice daily for two weeks |
| Ketoconazole 2% | Experimental | Drug: Ketoconazole 2%Antifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desonide 0.05%Desonide 0.05% ointment topically twice daily for two weeks | Drug | Desonide 0.05% |
| Ketoconazole 2%Ketoconazole 2% cream topically twice daily for two weeks | Drug | Ketoconazole 2% |
Primary outcome
Number of bacteria per each species
Time frame: 2 weeks after initial dispensing
Percentage of various bacteria present on each skin site
1 secondary outcome
Number of species at test sites
Time frame: 2 weeks after initial dispensing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emanual Maverakis, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
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.