Papular-pustular Rosacea, Papulopustular Rosacea, Papulopustular Rosacea (PPR)
Conditions
Keywords
rosacea, papulopustular rosacea, acneiform rosacea, PPR
Brief summary
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
Interventions
Clascoterone 1% cream
Sponsors
Sun Pharmaceutical Industries Limited
Narrows Institute for Biomedical Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. * Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
Exclusion criteria
* 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. * Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). * Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator. * Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. * Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. * Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline. | From enrollment to end of treatment at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of safety and adverse events | From enrollment to end of treatment at 12 weeks | We plan to calculate the incidence of adverse events. Study participants will be instructed to keep a log of all adverse events. |
| Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea. | From enrollment to end of treatment at 12 weeks | Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea. |
| Physician and study participants reported assessments at the end of the treatment compared to baseline | From enrollment to end of treatment at 12 weeks | 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 |
Countries
United States
Contacts
Primary ContactKayla N Zafar, BA
Outcome results
None listed