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Topical Steroid

Topical Medications for Healthy Subjects

Phase 1
Recruiting
Led By Emanual Maverakis, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after initial dispensing
Awards & highlights

Study Summary

This trial will help researchers understand how commonly used topical medications affect the human microbiome.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include local irritation, redness, itching at the application site from Ketoconazole or Desonide. Long-term use can lead to more serious side effects but this study focuses on short-term usage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after initial dispensing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after initial dispensing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of bacteria per each species
Secondary outcome measures
Number of species at test sites

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ketoconazole 2%Experimental Treatment1 Intervention
Antifungal topical medication applied to specific locations on the face and extremities, twice daily for two weeks
Group II: Desonide 0.05%Experimental Treatment1 Intervention
Low potency steroid topical medication applied to specific locations on the face and extremities, twice daily for two weeks

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,495 Total Patients Enrolled
Emanual Maverakis, MDPrincipal InvestigatorUC Davis
5 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

Desonide 0.05% (Topical Steroid) Clinical Trial Eligibility Overview. Trial Name: NCT03437005 — Phase 1
Healthy Subjects Research Study Groups: Desonide 0.05%, Ketoconazole 2%
Healthy Subjects Clinical Trial 2023: Desonide 0.05% Highlights & Side Effects. Trial Name: NCT03437005 — Phase 1
Desonide 0.05% (Topical Steroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03437005 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT03437005 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the initial foray into researching this particular phenomenon?

"Sanofi first began investigating Ketoconazole 2% in 2004, resulting in the drug's N/A approval. Since then, 10 active clinical trials for this medication have been conducted around 23 cities and 3 nations."

Answered by AI

How many individuals are partaking in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research endeavor is actively enrolling participants since it's initial posting on January 28th 2013; the most recent edit was made June 13th 2022. 24 people are needed from 1 trial center."

Answered by AI

What conditions has Ketoconazole 2% been approved to alleviate?

"Ketoconazole 2% is a widely-used remedy for coccidioidomycosis, as well as paracoccidioidomycosis, tinea corporis caused by trichophyton mentagrophytes and chromomycosis."

Answered by AI

Is it possible to enroll in this research program at present?

"Affirmative, clinicaltrials.gov data points to this trial as presently recruiting volunteers. The original listing was posted on the 28th of January 2013 and it was last updated 13 June 2022. 24 participants are needed across a single centre for inclusion in the study."

Answered by AI

Has the United States Food and Drug Administration approved Ketoconazole 2%?

"Due to the early stage of trialing, there is scant evidence demonstrating Ketoconazole 2%'s efficacy and safety; thus, our Power team rated it a 1 on their scale."

Answered by AI

Is there any prior research concerning Ketoconazole 2%?

"Presently, 10 clinical trials concerning Ketoconazole 2% are running with 1 study in its final phase. While the majority of these research efforts are based out of Rochester, Minnesota; a total of 28 locations across the globe have initiated studies regarding Ketoconazole 2%."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of California, Davis, Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am a healthy person and I want to help create advancements in the medical field by volunteering myself.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the whole trial going to be?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Alternation in the Human Microbiome With Commonly Used Topical Medications
2013. "Alternation in the Human Microbiome With Commonly Used Topical Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03437005.
All > Microbiome
~4 spots leftby Sep 2026
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