Dermatology

Below are current clinical trials.

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1. SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab

   Rochester, Minn.

   The primary objective of this study is to determine the safety profile of SX-682 alone and in combination with pembrolizumab in subjects with metastatic melanoma, including the maximum dose that can be administered until adverse effects prevent further dose increases (i.e., the MTD or recommended phase 2 dose), and the dose-limiting toxicity (DLT).

   The secondary objectives are to evaluate the efficacy of SX-682 in combination with pembrolizumab on the basis of the objective response rate, the duration of response, and the rate of progression, and to characterize the single-dose and multidose pharmacokinetic (PK) profile of SX-682.

2. A Study to Evaluate Immunotherapy and Ovarian Function Among Pre-menopausal Melanoma Survivors

   Rochester, Minn.

   The purposes of this study are to analyze the ovarian function of female premenopausal melanoma survivors who have undergone immunotherapy, and compare with data from age-matched controls, prospectively investigate ovarian function in premenopausal women with melanoma undergoing immunotherapy, and to identify the impact of ovarian function change on the frequency and function of CD8+ T cells during immunotherapy.

3. A Study to Collect Long-Term Data on Pediatric Cutaneous Mastocytosis

   Rochester, Minn.

   The purpose of this study is to develop a registry to collect long-term data on patients with pediatric cutaneous mastocytosis, and develop better knowledge of the timing, symptoms, resolution or progression of the disease, and predictive markers of its severity.

4. Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

5. A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus

   Jacksonville, Fla.

   The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.

6. PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to assess the safety, tolerability, and effectiveness of PRA023 in subjects with Systemic Sclerosis (SSc) with diffuse cutaneous disease and Interstitial Lung Disease (ILD). 

7. MElanoma Research Lymph node prediction Implementation National_001 (MERLIN_001)

   Rochester, Minn.

   This study aims to create a registry for primary melanoma gene-signature to predict sentinel node (SN) status and determine its prognostic value for more accurate staging of SN-negative melanoma patients.

8. A Study to Evaluate the Effectiveness and Safety of PCS499 in Treating Ulcerations in Patients who have Necrobiosis Lipoidica

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to evaluate the effectiveness of PCS499 at 6 Months in treating ulcerations in patients who have necrobiosis lipoidica.

9. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

10. C. Albicans during Early Life Predisposes Individuals to Atopy

    Rochester, Minn.

    The purpose of this study is to evaluate the contribution of C. albicans to dysbiotic microbial communities of mucosal tissues in pediatric populations. Prospective sampling across multiples tissue sites in a pediatric cohort will be used to assess which tissues are colonized by C. albicans and associated with microbial dysbiosis seen in atopic dermitis.

    We hypothesize presence of C. albicans in the microbial communities in early life is associated with atopy. We will assess the presence of C. albicans in the microbial communities of a population of children at-risk for atopic dermatitis compared to healthy controls who do not have an underlying risk for atopy based off family history. In tandem with the collection of human samples, we will utilize mouse models to validate the influence of C. albicans exposure during early life on the systemic immune populations.