Topical Medications for Healthy Subjects

Overseen By Lauren Downing

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Must not be taking: Antibiotics

Disqualifiers: Atopic dermatitis, Psoriasis, Seborrheic dermatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have used antibiotics in the last 6 months, you cannot participate.

What data supports the effectiveness of the drug ketoconazole 2% for treating skin conditions?

Research shows that ketoconazole 2% is effective in treating seborrheic dermatitis, a common skin condition, and has been used successfully in various formulations like foam and gel for fungal and yeast infections on the skin. ^{1 2 3 4 5}

Is ketoconazole generally safe for use in humans?

Ketoconazole, when used topically, is generally well-tolerated with some reports of mild side effects like skin redness and burning sensation, which usually do not require stopping the treatment. It is considered safe for treating skin infections, although rare allergic reactions can occur. ^{1 2 6 7 8}

What makes the drug Desonide 0.05% and Ketoconazole 2% unique compared to other treatments?

This drug combination is unique because it combines Desonide, a mild corticosteroid that reduces inflammation, with Ketoconazole, an antifungal that disrupts fungal cell membranes. The novel foam formulation of Ketoconazole enhances skin penetration and patient compliance, making it potentially more effective and user-friendly than traditional creams or ointments. ^{1 2 3 7 9}

What is the purpose of this trial?

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.

Research Team

Emanual Maverakis, MD

Principal Investigator

UC Davis

Eligibility Criteria

This trial is for adults over 18 who speak English and haven't used antibiotics in the last 6 months. It's not for those with chronic skin diseases, allergies to study medications, inability to consent, prisoners, or a history of skin cancer.

Exclusion Criteria

Non-English speaking individuals

I have a long-term skin condition like eczema, psoriasis, or similar.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical medications (Desonide 0.05% or Ketoconazole 2%) to specific locations on the face and extremities, twice daily for two weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in the skin microbiome and taxonomic diversity at test sites

2 weeks

Treatment Details

Interventions

• Desonide 0.05%
• Ketoconazole 2%

Trial Overview The study tests how two topical treatments—Ketoconazole (an antifungal cream) and Desonide (a low potency steroid ointment)—affect the human skin microbiome after short-term use.

Participant Groups

Group I: Ketoconazole 2% Experimental Treatment 1 Intervention

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

Group II: Desonide 0.05% Experimental Treatment 1 Intervention

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

Desonide 0.05% is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Desonide for:

• Atopic dermatitis
• Contact dermatitis
• Seborrheic dermatitis
• Psoriasis

Approved in Canada as Desonide for:

• Atopic dermatitis
• Contact dermatitis
• Seborrheic dermatitis
• Psoriasis

Approved in European Union as Desonide for:

• Atopic dermatitis
• Contact dermatitis
• Seborrheic dermatitis
• Psoriasis

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

In a study involving 1,162 participants aged 12 and older, ketoconazole 2% foam was found to be significantly more effective than a vehicle foam for treating seborrheic dermatitis, with a treatment success rate of 56% compared to 42%.

The ketoconazole foam demonstrated similar efficacy to ketoconazole cream and was well-tolerated, with only a 14% incidence of treatment-related adverse events, indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions. Elewski, BE., Abramovits, W., Kempers, S., et al.[2013]

In a study of 41 patients with superficial dermatomycosis, both ketoconazole 1% cream and clotrimazole 2% ointment showed similar efficacy in treating the condition over a maximum of 4 weeks.

While both treatments had side effects, ketoconazole caused mild reactions in 2 patients, whereas clotrimazole required discontinuation in 3 patients due to more severe skin reactions, suggesting that ketoconazole may be better tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind comparative examination of ketoconazole 1% cream and clotrimazole 2% ointment in superficial dermatomycosis. Török, I., Stehlich, G.[2013]

Topical ketoconazole is effective in treating fungal infections and seborrheic dermatitis by disrupting the synthesis of ergosterol, which is essential for fungal cell membranes.

New foam and gel formulations of ketoconazole are expected to improve patient compliance and preference, potentially increasing its use for skin conditions due to their ease of application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoconazole: a review of a workhorse antifungal molecule with a focus on new foam and gel formulations. Scheinfeld, N.[2017]

Ketoconazole has broad-spectrum antifungal activity, particularly effective against Malassezia species, making it suitable for treating various skin infections linked to these fungi.

A new 2% anhydrous gel formulation of ketoconazole has been developed, optimizing its anti-inflammatory, antiseborrheic, and antiproliferative properties to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of ketoconazole in seborrheic dermatitis. Borgers, M., Degreef, H.[2013]

Ketoconazole effectively inhibits testosterone production in human testicular cells at lower concentrations (IC50: 0.08 μmol/L) compared to canine (IC50: 0.1 μmol/L) and rat cells (IC50 ≥ 0.2 μmol/L), indicating a higher sensitivity in humans.

The mechanism of action differs by species; in humans, ketoconazole primarily affects the 17-hydroxylation step in testosterone biosynthesis, while in rats and dogs, it first inhibits the 17,20-lyase activity before affecting 17-hydroxylation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of ketoconazole on rat, dog and human testicular steroidogenesis. De Coster, R., Coene, MC., Van Camp, C., et al.[2019]

In a study of 60 patients with skin infections, flutrimazole 1% cream was found to be more effective than ketoconazole 2% cream, with 70% of flutrimazole-treated patients achieving negative cultures compared to 53% for ketoconazole after 4 weeks.

Flutrimazole demonstrated a similar safety profile to ketoconazole, with fewer patients experiencing adverse effects and a lower rate of asymptomatic carriers at the end of treatment, indicating it is a safe and effective option for treating dermatophytosis and candidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1% cream: double-blind, randomized comparative trial with ketoconazole 2% cream. del Palacio, A., Cuétara, S., Pérez, A., et al.[2019]

Ketoconazole is a highly effective and well-tolerated antifungal medication that maintains long-lasting therapeutic levels in the body, making it easy to administer with low toxicity.

It has shown high efficacy in treating various fungal infections, including pityriasis versicolor and candidosis, and does not appear to lead to the development of resistant fungi even after more than a year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketoconazole. 3 years' experience with a new orally active broadspectrum antimycotic]. Haneke, E.[2013]

Contact sensitivity to imidazoles, while infrequent, was observed in a review of 15 patients, with miconazole, econazole, tioconazole, and isoconazole identified as the most common allergens.

Significant cross-reactivity was found among certain imidazoles, suggesting that patients allergic to one may react to others; however, alternatives like ketoconazole and non-imidazole antifungals can be safely recommended for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact allergy to imidazoles used as antimycotic agents. Dooms-Goossens, A., Matura, M., Drieghe, J., et al.[2019]

Connetics Corporation is developing a 2% ketoconazole foam formulation called Extina, which shows promising efficacy trends for treating seborrhoeic dermatitis based on a pilot study with 50 patients.

Extina demonstrated superior skin penetration, being twice as effective as Nizoral cream in permeating the skin, which may enhance its therapeutic effectiveness for dermatological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoconazole foam--connetics: connetics ketoconazole foam. [2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions. [2013]

2. Hungary pubmed.ncbi.nlm.nih.gov

Double-blind comparative examination of ketoconazole 1% cream and clotrimazole 2% ointment in superficial dermatomycosis. [2013]

3. Spain pubmed.ncbi.nlm.nih.gov

Ketoconazole: a review of a workhorse antifungal molecule with a focus on new foam and gel formulations. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

The role of ketoconazole in seborrheic dermatitis. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative effects of ketoconazole on rat, dog and human testicular steroidogenesis. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Topical treatment of dermatophytosis and cutaneous candidosis with flutrimazole 1% cream: double-blind, randomized comparative trial with ketoconazole 2% cream. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Ketoconazole. 3 years' experience with a new orally active broadspectrum antimycotic]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Contact allergy to imidazoles used as antimycotic agents. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ketoconazole foam--connetics: connetics ketoconazole foam. [2018]