Alternation in the Human Microbiome With Commonly Used Topical Medications

• ClinicalTrials.gov Identifier: NCT03437005
• Recruitment Status: Recruiting
• First Posted: February 19, 2018
• Last Update Posted: April 28, 2021
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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. 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Desonide 0.05%; Drug: Ketoconazole 2%	Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Investigator)
• Masking Description: Investigator and subject will be blinded.
• Primary Purpose: Basic Science
• Official Title: Alterations in the Human Microbiome With Commonly Used Topical Medications
• Actual Study Start Date: January 28, 2013
• Estimated Primary Completion Date: September 28, 2026
• Estimated Study Completion Date: September 28, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of bacteria per each species [ Time Frame: 2 weeks after initial dispensing ]
   Percentage of various bacteria present on each skin site

Secondary Outcome Measures :

1. Number of species at test sites [ Time Frame: 2 weeks after initial dispensing ]
   The taxonomic diversity and evenness of each skin site's microbiome

Eligibility Criteria

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

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 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

Contacts and Locations

Contacts

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

Contact: Lauren Downing; 916-551-2635; ldowning@ucdavis.edu

Locations

United States, California

University of California, Davis, Department of Dermatology; Recruiting

Sacramento, California, United States, 95816

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

Contact: Lauren Downing 916-551-2635 ldowning@ucdavis.edu

Sponsors and Collaborators

University of California, Davis

Investigators

• Principal Investigator: Emanual Maverakis, MD; UC Davis

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03437005
• Other Study ID Numbers: 390406
• First Posted: February 19, 2018
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:

Human microbiome; Topical; Steroid; Anti-fungal

Additional relevant MeSH terms:

Ketoconazole; Desonide; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors; Anti-Inflammatory Agents