Alternation in the Human Microbiome With Commonly Used Topical Medications

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Desonide 0.05%; Drug: Ketoconazole 2%

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Emanual Maverakis, MD; Phone Number: 916-734-8254; Email: emaverakis@ucdavis.edu
• Study Contact Backup: Name: Lauren Downing; Phone Number: 916-551-2635; Email: ldowning@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • University of California, Davis, Department of Dermatology
      • Contact: Emanual Maverakis, MD; Phone Number: 916-734-8254; Email: emaverakis@ucdavis.edu
      • Contact: Lauren Downing; Phone Number: 916-551-2635; Email: ldowning@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%; Desonide 0.05% ointment topically twice daily for two weeks
Experimental: Ketoconazole 2%; Antifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks	Drug: Ketoconazole 2%; Ketoconazole 2% cream topically twice daily for two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bacteria per each species	Percentage of various bacteria present on each skin site	2 weeks after initial dispensing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of species at test sites	The taxonomic diversity and evenness of each skin site's microbiome	2 weeks after initial dispensing

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Emanual Maverakis, MD, UC Davis

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2013
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Steroid; Topical; Anti-fungal; Human microbiome
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole; Desonide
• Other Study ID Numbers: 390406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No