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Phosphodiesterase-4 (PDE-4) Inhibitor

Active plus vehicle arm for Rosacea

Phase 2

Waitlist Available

Research Sponsored by Dermatology Consulting Services, PLLC

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 12 weeks

Awards & highlights

Study Summary

This trial is testing a new medication for acne. It is a double blind study, which means that neither the subjects nor the researchers will know who is receiving the medication or the placebo. The study will last for 12 weeks, and the subjects will be asked to come in for research visits at baseline, Week 2, Weeks 4 and 8, and Week 12. At each visit, the researchers will collect information on the subject's medical history, concomitant medications, and adverse events. They will also collect urine and blood samples, and assess the subject's compliance with the study medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure

Secondary outcome measures

Measure

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active plus vehicle armActive Control1 Intervention

Subjects will be dispensed a tube containing roflumilast and vehicle in topical formulation

Group II: Vehicle armPlacebo Group1 Intervention

Subjects will be dispensed a tube containing vehicle only in a topical formulation

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Dermatology Consulting Services, PLLCLead Sponsor

2 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals have been accepted to participate in this trial?

"Correct. Clinicaltrials.gov reveals that this clinical trial, which was first advertised on April 15th 2022, is in the process of recruiting participants. 50 individuals must be sourced from a single medical centre."

Answered by AI

What criteria must be met in order to qualify for participation in this clinical trial?

"This clinical trial is searching for 50 participants aged 18-70 who have been clinically diagnosed with rosacea. To qualify, individuals must be willing to abstain from external factors that may trigger a flare up (e.g., spicy foods and hot environments), use the same makeup brands/types for 14 days prior to enrollment, legally competent to sign consent forms or assent if below legal age in their location of residence, present moderate to severe papules and pustules on the face but no more than 2 nodules, display erythema or flushing on the face and provide negative pregnancy tests at both screening and baseline visits"

Answered by AI

Has the combination of Active and vehicle components been approved by the Food & Drug Administration?

"The safety of the Active plus vehicle arm was evaluated to be 2 on a scale of 1-3 given that there is only evidence attesting to its security, and no data supporting efficacy."

Answered by AI

Are there opportunities for enrollment in this research trial?

"Yes, according to clinicaltrials.gov, this study is actively seeking participants and was first published on April 15th 2022 with the most recently update occurring March 28th of the same year. The research team needs 50 patients from a solitary medical centre in order to proceed."

Answered by AI

Does this experiment accept volunteers over two decades old?

"This clinical trial requires applicants to be between 18 and 70 years old. There are 1 studies for those younger than 18, while 12 offer treatments and trials dedicated to individuals over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

Zoe Diana Draelos, MD 2022. "Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278624.