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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | INDUSTRY |
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To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Acneiform or Papulopustular Rosacea | Experimental | Patients with diagnosis of papulopustular or acneiform rosacea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clascoterone Cream 1% | Drug | Clascoterone 1% cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla N Zafar, BA | Contact | 718-836-6600 | 7023 | kayla.zafar@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jared Jagdeo, MD MS | SUNY Downstate Health Sciences University Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Harbor VA Brooklyn Campus | Recruiting | Brooklyn | New York | 11209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27250651 | Background | Liakou AI, Nyengaard JR, Bonovas S, Knolle J, Makrantonaki E, Zouboulis CC. Marked Reduction of the Number and Individual Volume of Sebaceous Glands in Psoriatic Lesions. Dermatology. 2016;232(4):415-24. doi: 10.1159/000445942. Epub 2016 Jun 2. | |
| 15153893 | Background | Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available. |
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IPD may not be shared because this study is conducted at a VA hospital with a small sample size
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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 |
| 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:
| From enrollment to end of treatment at 12 weeks |
| 25848978 | Background | Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Deret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7. |
| 18786498 | Background | Brelsford M, Beute TC. Preventing and managing the side effects of isotretinoin. Semin Cutan Med Surg. 2008 Sep;27(3):197-206. doi: 10.1016/j.sder.2008.07.002. |
| 32164966 | Background | Khalil NY, Darwish IA, Al-Qahtani AA. Isotretinoin. Profiles Drug Subst Excip Relat Methodol. 2020;45:119-157. doi: 10.1016/bs.podrm.2019.10.005. Epub 2019 Dec 6. |
| 26915718 | Background | Tan J, Schofer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia - The RISE study. J Eur Acad Dermatol Venereol. 2016 Mar;30(3):428-34. doi: 10.1111/jdv.13556. |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C496269 | Clascoterone |
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