Rosacea Clinical Trial - Evaluation of the Safety & Efficacy of Topical

Status Completed

Clinical Trial Summary

This is a double blind single site vehicle controlled study. The following activities will be conducted at each visit. Baseline Research Center Visit Obtain a signed and dated, written ICF prior to any study-related procedures.· Obtain demographic data· Assign subject number based on the order in which subjects present to the research center· Obtain medical/surgical history· Obtain concomitant medications· Assess eligibility based on inclusion/exclusion criteria· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Perform serum pregnancy test in all women of child bearing potential (WOCBP)· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for baseline visit· Randomize subject and dispense Investigational Study Medication and use instructions along with compliance diary· Schedule return visit Week 2 Phone Call· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Assess compliance Weeks 4, 8 Research Center Visit Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication, collect used Investigational Study Medication and redispense as necessary· Schedule return visit Week 12 Research Center Visit· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication· Collect diary and Investigational Study Medication· Release subject from study participation

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Rosacea

Clinical Trial Details

NCT number	NCT05278624
Study type	Interventional
Source	Dermatology Consulting Services, PLLC
Contact
Status	Completed
Phase	Phase 2
Start date	April 15, 2022
Completion date	February 17, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05597462` - Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks	Phase 1
Completed	`NCT02601963` - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea	Phase 2
Completed	`NCT02249065` - Mirvaso in Use Study	Phase 4
Completed	`NCT02292797` - Assessment of the Rosacea Prevalence in the General Population	N/A
Completed	`NCT01659853` - Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea	Phase 3
Completed	`NCT01426269` - Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo	Phase 4
Completed	`NCT00991198` - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage	Phase 2
Terminated	`NCT04336163` - Skin Imaging to Inform Laser Treatments	N/A
Recruiting	`NCT04108897` - Analysis of the Microbiome in Rosacea	Early Phase 1
Completed	`NCT03872050` - Deep Phenotyping of Rosacea and Migraine
Active, not recruiting	`NCT06033352` - Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea	Phase 2
Completed	`NCT03263273` - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea	Phase 2
Completed	`NCT04508205` - CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes	Phase 1
Completed	`NCT04508660` - CGB-400 for the Reduction of Facial Redness	Phase 1
Completed	`NCT05094700` - A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants	N/A
Active, not recruiting	`NCT03211585` - EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA	N/A
Completed	`NCT02637232` - Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
Completed	`NCT02576847` - Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel	Phase 3
Completed	`NCT02576860` - Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle	Phase 3
Completed	`NCT02583009` - A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms