This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.
Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.
During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.
The research study is testing a new investigational treatment for epidermolysis bullosa (EB). Chronic, non-healing wounds are a major source of complications in patients with EB. Both acute and chronic wounds impact the quality of life due to itching, pain, and the need for wound dressing changes. The study treatment is called Oleogel-S10. This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to investigate whether Oleogel-S10 is effective and safe in the long-term use. Oleogel-S10 will be compared with a vehicle gel. The vehicle gel is an identical-looking sunflower-oil?based gel that does not contain any active substance (a placebo). The double-blind treatment phase of this study will last for a duration of 3 months. Afterwards, Oleogel-S10 will be provided for 2 years in the follow-up study. In total, there will be 10 scheduled visits and 1 flexible visit in the course of this study.
This study will evaluate the biomarkers of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, whose disease is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.
This is not a treatment study. This study is only recruiting volunteers who are enrolled into an atopic dermatitis registry known as Pedistad. Participation in this study will involve 6 visits every 12 months over a period of 5 years.The information collected in this study may lead to an improved understanding of atopic dermatitis and may provide healthcare providers with important information for treating atopic dermatitis in the future.
KD025 is an investigational medication undergoing testing to determine if it may be effective in the treatment of diffuse systemic sclerosis (skin thickening on more than just the hands). KD025 has previously been tested in graft-versus-host disease, idiopathic pulmonary fibrosis, and psoriasis. It has shown preliminary effectiveness and safety in the treatment of these conditions. This study will randomly assign subjects to one of three treatment groups, 20mg of KD025 twice per day, 20mg of KD025 once per day, and placebo. The study will measure the improvement, stabilization or worsening of your symptoms, such as changes in your fatigue and pain levels, lung function, skin thickness and other patient reported outcomes. The study treatment period will last 1 year. The drug may help mitigate symptoms of systemic sclerosis and thus may be helpful with the disease in study. The population to be enrolled in this study will involve patients diagnosed with systemic sclerosis, diffuse subset, 18 years of age or older.
This is a study of upadacitinib versus dupilimab in adult subjects (18-75 years of age) with moderate to severe atopic dermatitis. The study drug, upadacitinib, is an oral medical that is a tablet taken once a day. Dupilimab is given as an injection under the skin every other week. The subject's participation includes a 35-day screening period, a 24-week double-blind treatment period, and an End of Treatment Follow-up visit 12 weeks after the last injection.
The main purpose of this study is to see if taking KPL 716 is effective in relieving itch. The study will also assess whether KPL-716 is effective in improving sleep and quality of life or whether it can promote healing of the skin. This study will compare KPL-716 to a placebo. This study is being done to learn if KPL-716 is an effective and safe treatment for participants with moderate to severe prurigo nodularis experiencing moderate to severe itching. KPL is administered through a subcutaneous injection (shot). Participation in the study will take about 13 visits over a period of 20 weeks.
This is a multi-center study of the safety and effectiveness of an experimental study drug in treatment of subjects diagnosed with moderate to severe lamellar ichthyosis (LI). The investigational cream will be applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. Participation in the study will last 12 weeks (approximately 6 visits) with the option to continue for another 12 weeks (approximately 5 visits) for a total study duration of up to 24 weeks in total. Compensation may be provided.
This study is to treat patients with alopecia areata for whom topical treatments have not been effective. This study will evaluate the safety and efficacy of systemic treatment with baricitinib.
Participation in the study will take about 20 visits over a period of about 17 months.
This international study will enroll males and females age 18 years and older who have been diagnosed with prurigo nodularis. The study involves an oral experimental (investigational) drug, called nalbuphine ER, that is being tested for the treatment of prurigo nodularis. Regularly scheduled visits to the study center will be required (approximately 15) and participation is expected to last up to 60 weeks. Compensation will be provided for participants.
The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).