Alternation in the Human Microbiome With Commonly Used Topical Medications
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | January 28, 2013 |
| End Date: | September 28, 2026 |
| Contact: | Emanual Maverakis, MD |
| Email: | emaverakis@ucdavis.edu |
| Phone: | 916-734-8254 |
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.
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.
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.
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.
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
We found this trial at
1
site
Sacramento, California 95816
Phone: 916-734-8254
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