Treatment Trials

458 Clinical Trials for Various Conditions

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A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Description

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size. This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth. In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab. In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks. Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Conditions

Pyoderma Gangrenosum

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
Description

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

Conditions

Hidradenitis Suppurativa (HS)

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
Description

This study is open to people with a skin disease called Netherton syndrome (NS). People can join the study if they are 12 years or older. The purpose of this study is to find out whether a medicine called spesolimab helps people with NS. Participants are divided into a spesolimab and a placebo group. Placebo injections look like spesolimab injections but do not contain any medicine. Every participant has a 2 in 3 chance of being in the spesolimab group. In the beginning, participants get the study medicine as an injection into a vein. Afterwards, they get it as an injection under the skin every month. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants are in the study for up to 3 years. During this time, they visit the study site up to 42 times. The doctors regularly check participants' NS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

Conditions

Netherton Syndrome

Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
Description

The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.

Conditions

Wrinkles, Scars, Stretch Marks, Pigmentation, Skin Laxity

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Description

This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

Conditions

Hidradenitis Suppurativa

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
Description

Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

Conditions

Skin Laxity

Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders
Description

Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.

Conditions

Skin Diseases

Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Description

Incisional dressings aim to prevent contamination of an incisional wound and protect against skin irritation. Surgeons use incisional negative pressure wound therapy (iNPWT) to manage incisional wounds. This study compares a new dressing designed for use with iNPWT that aims to improve comfort, tolerability, and dressing survivability over the standard of care for iNPWT. Further, no evidence exists that shows NPWT reduces the bacterial burden on the skin. This study will compare the incidence of skin irritation, dressing damage or lift, and changes in bacteria flora on healthy volunteer skin.

Conditions

Skin Reaction to Mechanical, Thermal and Radiation Stimuli, Skin Sensitisation

Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions
Description

The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.

Conditions

Skin Lesion

Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Description

The purpose of this study is to assess the degree of improvement seen patient reported outcomes after 30 sessions of UVA-1 therapy in treating systemic scleroderma, morphea, and sclerodermatous Graft-Versus-Host Disease. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, patient reported outcomes have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, patient reported outcomes may offer a better way to study the impact of treatments like UVA-1. This will be a non-blinded, non-randomized prospective trial using UVA-1 phototherapy in patients with established sclerosing skin disease. Patients will report the severity of their condition using multiple patient reported outcomes and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions.

Conditions

Scleroderma, Systemic, Morphea, Graft Vs Host Disease

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Description

This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

Conditions

Hidradenitis Suppurativa

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Description

This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

Conditions

Hidradenitis Suppurativa

Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Description

This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.

Conditions

Psoriasis Vulgaris

Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions
Description

The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.

Conditions

Pigmentation

Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
Description

Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis.

Conditions

Atopic Dermatitis, Eczema

Tofacitinib for Immune Skin Conditions in Down Syndrome
Description

People with Down syndrome (DS) display widespread immune dysregulation, including several immune skin conditions. This study hypothesizes that pharmacological inhibition of the increased interferon (IFN) signaling seen in DS is safe and could improve associated skin conditions. The study evaluates the safety and efficacy treatment with Tofacitinib, an FDA-approved drug known to block IFN signaling, in adolescents and adults with DS and an autoimmune and/or autoinflammatory skin condition. Investigators will also measure the impact of interferon inhibition on a variety of molecular markers, as well as the cognitive abilities and quality of life of participants.

Conditions

Down Syndrome, Alopecia Areata, Atopic Dermatitis / Eczema, Hidradenitis Suppurativa, Vitiligo, Psoriasis

A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
Description

The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety. Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.

Conditions

Palmoplantar Pustulosis (PPP)

Methods Validation Assessment for Study of Inflammatory Skin Disease
Description

1. Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease 2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.

Conditions

Lichen Planus

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
Description

To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

Conditions

Generalized Pustular Psoriasis

The Impact of Pediatric Skin Disorders: The "Big" Study
Description

This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.

Conditions

Chronic Pediatric Skin Conditions

Dermal Cooling System for Cryotherapy of Common Skin Conditions
Description

Prospective, non-randomized, open-label study to evaluate the dermal cooling system for cryotherapy of common skin conditions.

Conditions

Skin Lesion

Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Description

Investigators will sample the skin and blood of patients with chronic skin conditions (including but not limited to atopic dermatitis (AD), contact dermatitis, hidradenitis suppurativa (HS), and psoriasis) to study the expression of anti-oxidative enzymes, skin barrier proteins and inflammatory molecules. In patients with atopic dermatitis, investigators will also measure skin barrier function using noninvasive devices. These results will be correlated with the disease severity in atopic dermatitis patients.

Conditions

Atopic Dermatitis, Hidradenitis Suppurativa, Contact Dermatitis, Psoriasis

The Role of Bacterial Toxins in Human Skin Disease
Description

Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial infections and inflammation. Studies indicate that skin cells from these patients may have some changes that make these patients more susceptible to bacterial infections. Inflammatory environment may have an effect on the function of skin cells. The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts) and how they regulate skin barrier function. To study this we need to establish skin cells that can be grown in the laboratory. We will use small skin biopsies from patients with atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin cells have a limited lifetime when grown in laboratory as part of the project we would like to modify them, which allows them to grow for long time in the research laboratory. Some of the collected skin biopsies and isolated skin cells will be used to examine what gene products they make.

Conditions

Atopic Dermatitis, Psoriasis

A Study of LY3041658 in Participants With Skin Diseases
Description

The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.

Conditions

Skin Diseases, Psoriasis

Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
Description

This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

Conditions

Actinic Keratosis, Acne/Rosacea, Verruca Plana, Tinea, Molluscum Contagiosum, Bowen's Disease, Warts

Anakinra for Inflammatory Pustular Skin Diseases
Description

Background: * Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the bodys tissues. These diseases cause painful and itchy skin rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these diseases suppress the immune system. However, they can cause severe side effects when taken over a long period of time. * Interleukin 1 (IL-1) is a small protein that may be important in causing the inflammation seen in pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been effective in treating some inflammatory conditions such as rheumatoid arthritis. However, anakinra has not been studied for use in patients with pustular skin disease. Researchers want to see whether anakinra will be effective in treating pustular skin disease. Objectives: - To see if anakinra can be used to treat inflammatory pustular skin disease. Eligibility: - Individuals at least 18 years of age who have inflammatory pustular skin disease. Design: * Participants will be screened with a physical exam and medical history. Their disease will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may also be collected. * Participants will have an initial visit to receive the first dose of anakinra. They will be shown how to give themselves daily injections of anakinra. * Participants will take anakinra for up to 12 weeks as long as there are no severe side effects. During this time, they will keep a study diary to record the severity of any rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary to their study visits. * Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored at these visits with blood tests, urine tests and physical exams. Depending on the effects of the treatment, participants may have the dose of anakinra increased or decreased. * Participants will have a final study visit 4 weeks after they stop taking anakinra.

Conditions

Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau, Pustular Psoriasis, Palmoplantar Pustulosis

Observational Evaluation of the Peristomal Skin Condition in Ostomates
Description

The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.

Conditions

Ostomy

Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
Description

This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat and prevent recurrence of AKs. The target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.

Conditions

Actinic Keratosis, Organ or Tissue Transplant; Complications

A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis
Description

This study is designed to evaluate the safety and efficacy of an oral medicine (called apremilast) for treating skin involvement in patients with the disease dermatomyositis.

Conditions

Dermatomyositis

"A Randomized, Controlled, Evaluator-blinded Pilot Study to Evaluate the Effect of Automated Text Message Reminders on Patient Compliance With Topical Medications and Its Efficacy on Skin Disease Control in Adolescents and Adults With Mild to Moderate Acne"
Description

The purpose of this study is to determine whether an automated electronic reminder system using text messages sent to patient's cell phones will help patients with acne be more compliant with their topical medications and lead to an improvement of their acne. Hypothesis: Automatically delivered electronic reminders in the form of text messages will increase acne patient adherence to topical medications and consequently result in better treatment outcome and higher patient satisfaction

Conditions

Acne, Patient Compliance