Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNarrows Institute for Biomedical Research
About this trial
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women ages 18+.
Diagnosis of rosacea type 2 (papulopustular).
Available and willing to comply with study instructions and attend all study visits.
Able and willing to provide written and verbal informed consent.
Disqualifiers
Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Trial design
Design model
Single group
Treatments tested in this trial
Clascoterone Cream 1%
DrugClascoterone 1% cream
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with Acneiform or Papulopustular RosaceaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
We will perform both a paired and pooled statistical analysis. We will conduct a power analysis to determine statistical significance. For the paired analysis, we will calculate the average gland size per patient at baseline and again at the end of the treatment period from all the individual's biopsy sites. We will then calculate the percent reduction of sebaceous gland size between the two average sizes. Finally, we will calculate the average percent change across all participants. For the pooled analysis, we will calculate the average sebaceous gland size across all study participants before and after treatment. We will use these two values to calculate the percent change. We anticipate that the paired analysis will yield more meaningful results as the pooled analysis may not show significant change due to the variations between study participants used to calculate the averages.
Time frame
From enrollment to end of treatment at 12 weeksSecondary outcomes
1
Evaluation of safety and adverse events
We plan to calculate the incidence of adverse events. Study participants will be instructed to keep a log of all adverse events.
Time frame
From enrollment to end of treatment at 12 weeks2
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Time frame
From enrollment to end of treatment at 12 weeks3
Physician and study participants reported assessments at the end of the treatment compared to baseline
A modified, succinct version of the Rosacea clinical scorecard as proposed by the Report of the National Rosacea Society Expert Committee on the Classification and Staging of sRosacea will be used to assess these measures. Physicians and study participants will be asked to grade the rosacea at baseline and at the end of the treatment based on the following scale: * Subtype 1: Erythematotelangiectatic: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Subtype 2: Papulopustular: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Subtype 3: Phymatous: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Global Assessment: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
Time frame
From enrollment to end of treatment at 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Narrows Institute for Biomedical Research
Lead sponsor
Sun Pharmaceutical Industries Limited
Collaborator
Source ClinicalTrials.gov