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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how common skin treatments affect the skin's microbiome, the tiny organisms living on the skin. It tests two treatments: ketoconazole cream, which combats fungal infections, and desonide ointment, a mild steroid that reduces skin irritation. Participants will apply these treatments to their face and limbs for two weeks. Suitable candidates are adults without ongoing skin conditions like eczema or psoriasis and who haven't recently used antibiotics. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking skin health research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both desonide 0.05% and ketoconazole 2% are generally safe for skin use. Some individuals using desonide have experienced minor side effects such as skin irritation, redness, or dryness, which are typically mild and resolve on their own. More serious side effects, like high blood sugar or liver problems, are rare and occur in only a small number of cases.

Studies on ketoconazole cream indicate it may cause burning, itching, or irritation at the application site. These are the most common reactions and are usually not severe. It is important to note that ketoconazole should be used cautiously by individuals with liver problems, although this risk is more relevant for the oral form of the drug.

Both treatments are applied to the skin and do not present serious safety concerns with short-term use. However, monitoring for any unusual reactions and consulting a healthcare provider if concerns arise is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Desonide 0.05% and Ketoconazole 2% because they offer targeted topical solutions with potentially fewer side effects. Desonide 0.05% is a low-potency steroid, which means it can reduce inflammation effectively while minimizing the risk of skin thinning, a common side effect of stronger steroids like clobetasol. Ketoconazole 2%, an antifungal agent, not only tackles fungal infections but also exhibits anti-inflammatory properties, making it useful for conditions that involve both fungi and inflammation. These treatments apply directly to affected areas, which may offer faster relief and better control compared to systemic medications.

What evidence suggests that this trial's treatments could be effective for altering the human skin microbiome?

This trial will compare two topical medications: Desonide 0.05% and Ketoconazole 2%. Research has shown that Desonide 0.05% ointment relieves symptoms like redness and itching in skin conditions such as atopic dermatitis, leading to significant improvement and proving safe for long-term use. Meanwhile, Ketoconazole 2% cream effectively treats fungal infections like athlete's foot, reducing symptoms in just a few weeks. Both treatments have strong evidence supporting their effectiveness for their specific uses, demonstrating improvements in skin conditions and fungal infections. ^{2 3 6 7 8}

Who Is on the Research Team?

Emanual Maverakis, MD

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3225140/

Randomized Controlled Trial of Desonlde Hydrogel 0.05% ... Desonide hydrogel 0.05% and desonide ointment 0.05% successfully treated the symptoms of mild-to-moderate AD. Both formulations were significantly effective in ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2006/021978s000_SumR.pdf

SUMMARY REVIEW Desonide at 0.05% is already approved in other products. The long term safety update profie for the drug substance at the concentration ...

3. mayoclinic.org mayoclinic.org/drugs-supplements/desonide-topical-application-route/description/drg-20073898

Desonide (topical application route) - Side effects & dosage Desonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (eg, atopic dermatitis).

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7601950/

Multicenter trial for long-term safety and efficacy ... Desonide ointment showed greater efficacy, produced more rapid improvement, and demonstrated an equivalent cutaneous safety profile when compared with 1% ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021978s015lbl.pdf

VERDESO (desonide) foam, for topical use - accessdata.fda.gov The safety and efficacy of VERDESO Foam has not been established beyond 4 weeks of use. Unless directed by a physician, VERDESO Foam should not ...

6. vionausa.com vionausa.com/wp-content/uploads/2020/07/SDS-Desonide-Cream.pdf

Safety Data Sheet Desonide Cream, 0.05% Strength These were hyperglycemia (2%) and liver function abnormality (1%). The following additional local adverse reactions have been reported infrequently with topical ...

7. webmd.com webmd.com/drugs/2/drug-4079-420/desonide-topical/desonide-cream-gel-ointment-topical/details

Desonide topical: Uses, Side Effects, Interactions, Pictures, ... Find patient medical information for Desonide topical on WebMD including its uses, side effects and safety, interactions, pictures, warnings ...

8. drugs.com drugs.com/mtm/desonide-topical.html

Desonide topical Uses, Side Effects & Warnings Desonide topical side effects · stinging or burning of treated skin; · skin irritation, redness, itching, or hardening; · dry, scaly, or oily skin;.