Alternation in the Human Microbiome With Commonly Used Topical Medications

NCT03437005 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 390406
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 1.Investigate whether ketoconazole cream, a commonly used topical antifungal, causes alterations in the human skin microbiome with short-term use.
2. 2.Investigate whether desonide 0.05 % ointment, a commonly used low potency topical steroid, alters the human microbiome with short-term use.

Conditions

Healthy

Keywords

Human microbiome; Topical; Steroid; Anti-fungal

Outcome Measures

Primary Outcomes (1)

• Number of bacteria per each species

  Percentage of various bacteria present on each skin site

  2 weeks after initial dispensing

Secondary Outcomes (1)

• Number of species at test sites

  2 weeks after initial dispensing

Study Arms (2)

Desonide 0.05%

EXPERIMENTAL

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

Drug: Desonide 0.05%

Ketoconazole 2%

EXPERIMENTAL

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

Drug: Ketoconazole 2%

Interventions

Desonide 0.05% DRUG

Desonide 0.05% ointment topically twice daily for two weeks

Desonide 0.05%

Ketoconazole 2% DRUG

Ketoconazole 2% cream topically twice daily for two weeks

Ketoconazole 2%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

RECRUITING

Study Officials

• Emanual Maverakis, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanual Maverakis, MD

CONTACT

916-734-8254; emaverakis@ucdavis.edu

Lauren Downing

CONTACT

916-551-2635; ldowning@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator and subject will be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be randomized to one of two groups, with one group receiving ketoconazole cream and the other receiving desonide ointment.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: January 28, 2013
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)