Clinical trials on Atopic dermatitis (AD)

Understanding Atopic Dermatitis (AD)

Atopic Dermatitis (AD), commonly known as eczema, is a chronic skin condition characterized by itchy, inflamed, and often red skin. It is a prevalent condition affecting individuals of all ages, though it most frequently begins in childhood. The exact cause of AD is not fully understood, but it is believed to involve a combination of genetic, environmental, and immune system factors. People with AD often have a family history of other atopic disorders, such as asthma or hay fever, suggesting a strong genetic predisposition.

The symptoms of AD can vary significantly from person to person but typically include dry skin, severe itching, red patches, swelling, and sometimes oozing or crusting. These symptoms can lead to sleep disturbances and impact the quality of life due to the constant discomfort and visible skin changes. The condition tends to flare up periodically and then subside, with triggers including stress, skin irritants, allergens, and changes in temperature or humidity.

Management and Treatment

While there is currently no cure for AD, there are various strategies to manage symptoms and reduce flare-ups. These include moisturizing regularly, avoiding known triggers, and using prescribed medications such as topical corticosteroids or calcineurin inhibitors to control inflammation and itching. In more severe cases, systemic treatments or biologic drugs may be recommended. Additionally, lifestyle modifications, such as wearing soft, breathable clothing and using gentle skin care products, can significantly improve comfort and skin condition.

It is essential for individuals with AD to work closely with healthcare professionals to develop a personalized treatment plan. Regular follow-ups can help adjust the treatment as needed and provide support in managing this often challenging condition. With proper management, most people with AD can lead comfortable, fulfilling lives.

Prognosis for Atopic Dermatitis

Atopic dermatitis (AD) is a chronic skin condition characterized by itchy, inflamed skin. The long-term prospects for those with atopic dermatitis vary widely, as the severity and frequency of flare-ups differ among individuals. An improvement in symptoms with age is observed in many cases, and children with AD may see their condition resolve by adolescence. However, symptoms may persist into adulthood for some. The course of atopic dermatitis is often unpredictable, with periods of remission interspersed with exacerbations. While the condition can persist over time, careful management can lead to significant relief of symptoms and improved quality of life. It is important to note that the emotional and psychological impact of living with atopic dermatitis can be substantial, and support for these aspects is also a crucial component of managing the long-term prognosis of the disease.

Complications in Atopic Dermatitis

Atopic dermatitis, commonly known as eczema, can lead to several complications that impact health and daily living. Skin infections are frequent due to the constant urge to scratch, which can break the skin and allow germs to enter. This scratching cycle can also cause thickened, leathery skin patches, known as lichenification, which may be sensitive and painful. Sleep disturbances are common, as itching often worsens at night, leading to fatigue and affecting mood and concentration. Additionally, there may be emotional distress, with a feeling of self-consciousness about the skin’s appearance, which can lead to decreased social interactions and impact mental well-being. Eye problems, such as inflammation of the eyelid (blepharitis) or the cornea (keratoconus), can occur, potentially affecting vision. Awareness of these complications is important for effective management of the condition and maintenance of quality of life.

Treatment Methods for Atopic Dermatitis

For the management of Atopic Dermatitis, several non-clinical trial options are recommended:

  • Dietary adjustments can play a significant role; the incorporation of anti-inflammatory foods such as omega-3-rich fish and a variety of fruits and vegetables may be helpful. The reduction of processed foods and allergens intake is also beneficial.
  • Physical activity is encouraged to improve overall health, but excessive sweating and irritation that could aggravate the skin should be avoided. Gentle exercises are preferable.
  • Pharmacotherapy options include over-the-counter creams and ointments to moisturize the skin and relieve itching. Topical corticosteroids may be used for more severe cases, and antihistamines can help in managing itching, especially at night.
  • Modern technology offers wearable devices that track scratching and skin moisture levels, aiding in the prevention of flare-ups. Ultraviolet light therapy is another advanced treatment, utilizing controlled exposure to UV light to reduce symptoms.

These methods, combined with a consistent skincare routine, can significantly alleviate the discomfort associated with Atopic Dermatitis.

  • Evaluating the efficacy and safety of cyclosporine and methotrexate in children with moderate to severe atopic dermatitis

    This study aims to assess how well and how safe two medicines, cyclosporine and methotrexate, are in treating children who have a skin condition known as moderate to severe atopic dermatitis. Atopic dermatitis can make the skin very itchy and red, and it’s more commonly known as eczema.

    The main goal of this research is to see if these two medicines can help children with eczema better than the treatments that are currently approved and available. Researchers want to find out if using cyclosporine and methotrexate can improve symptoms, how safe these treatments are when given to children, and if there are any differences in their effectiveness or safety. Another important aspect of this study is to see how long the improvements last after the treatment has ended.

    The findings from this study could provide new information that might help doctors and patients decide on the best ways to treat severe eczema in children in the future. The study is intended for children aged 2 to 18 years old.

    • Methotrexate
    • Cyclosporine A
  • Study on ruxolitinib cream for hand eczema

    This study investigates the use of ruxolitinib cream for adults with chronic hand eczema, a skin condition causing itchy, red, and cracked skin on the hands. The cream is applied directly to the affected areas twice daily for 16 weeks. Participants in the study, who are adults with moderate to severe hand eczema, are either given ruxolitinib cream or a placebo cream. After 16 weeks, all participants can choose to continue with ruxolitinib cream for another 16 weeks. The study aims to find out if this cream can effectively reduce the symptoms of hand eczema, like itchiness and skin pain, and improve overall skin condition and quality of life. Around 180 people are taking part in this study, which doesn’t include healthy volunteers​.

    • Ruxolitinib cream
    • Vehicle
  • Evaluating Delgocitinib’s effect on Chronic Hand Eczema

    This is a study designed for teenagers aged 12 to 17 who are experiencing long-term and severe cases of hand eczema. The research aims to investigate whether a cream containing delgocitinib can be effective in treating this condition and to assess any potential side effects. Delgocitinib works by reducing inflammation, a key aspect of the body’s response in diseases like eczema. The study duration is 22 weeks, during which each participant will use either the delgocitinib cream or a cream without the active ingredient twice daily. The study will closely monitor improvements in the participants’ eczema, the impact on their daily life, and any observed side effects.

    • Delgocitinib
  • Study on dosing of upadacitinib for moderate to severe atopic dermatitis

    The drug upadacitinib is being studied to assess its potential dose-dependent effectiveness in supporting adults struggling with a difficult-to-treat skin disease called atopic dermatitis (AD). The study will recruit approximately 450 adults with moderate to severe AD. The study will last approximately six months. The study consists of two parts: a 12-week double-blind period during which neither participants nor researchers know who is receiving the actual drug versus a placebo, followed by a 12-week single-blind period during which participants they know they are receiving upadacitinib, but the researchers do not. The main goal is to assess how well the drug can control the symptoms of atopic dermatitis if the dosage is adjusted based on the patient’s response to treatment.

    • Upadacitinib
  • Testing new potential treatment for the skin condition atopic dermatitis

    This trial is designed to understand the effects of a drug called UCB9741 on individuals, both healthy and those suffering from Atopic Dermatitis, a type of eczema that makes the skin red and itchy. The study focuses on assessing how safe the drug is, how the body handles the drug (known as pharmacokinetics), and how effective it is in improving the skin condition in those affected by Atopic Dermatitis.

    Participants in the study receive UCB9741 either through an IV (a tube placed in a vein) or as a shot under the skin. The study closely monitors the participants for any side effects to ensure the drug’s safety. It also measures the levels of the drug in the blood over time to understand how the body processes it.

    The goal is to gather detailed information about UCB9741’s safety and its potential benefits in treating Atopic Dermatitis, contributing to the development of new treatment options for this challenging skin condition.

    • UCB9741- new potential medication for atopic dermatitis
  • Testing the effectiveness of Rocatinlimab on Atopic Dermatitis

    This study is focused on testing a medication called rocatinlimab for teenagers with a skin condition known as Atopic Dermatitis. The goal is to assess whether rocatinlimab can improve their skin condition over the course of a year. The study will involve comparing the outcomes of those who receive the actual medication with those who receive a placebo. Importantly, the study is designed as a double-blind trial, meaning that neither the participants nor the researchers will know who received the real medicine and who received the placebo. The study aims to thoroughly evaluate the safety and effectiveness of rocatinlimab. The primary objective is to determine whether rocatinlimab is indeed effective and safe for teenagers with Atopic Dermatitis.

    • Rocatinlimab
  • Testing rocatinlimab for Atopic Dermatitis

    This study tests rocatinlimab combined with topical treatments in adults with moderate-to-severe atopic dermatitis (skin allergy). The study is set to last 24 weeks, and it uses a method which guarantees that neither the patient nor the doctors know if the patient is using Rocatinlimab or a placebo. It checks if this new weekly treatment can improve skin health and reduce itchiness better than a placebo. The research aims to offer an effective solution, improving life quality for those with this skin condition.

    • Rocatinlimab
  • Testing the safety and effectiveness of a new drug in adults with atopic dermatitis

    This trial involves the exploration of a new medication, GSK1070806, for adults afflicted with moderate to severe atopic dermatitis, a skin condition characterized by redness and itching. Over a 16-week period, participants are administered either the new medication or a placebo, a substance devoid of therapeutic properties. This double-blind study ensures that neither the participant nor the doctor is aware of the treatment allocation. Parameters assessed include the medication’s efficacy, safety, drug metabolism within the body, and its impact on the disease. An essential metric is the EASI score, reflecting the severity of the skin condition. Additional assessments encompass the evaluation of itchiness levels, pain intensity, and the disease’s effect on sleep and fatigue. Physicians also document any adverse events, which pertain to unexpected medical incidents related to the drug, and ascertain causality.

    • GSK1070806- new potential medication for chronic inflammatory conditions
  • Discovering a new drug for atopic dermatitis

    This clinical trial aims to evaluate the safety and effectiveness of LEO 138559, a new medication for adults with moderate-to-severe atopic dermatitis, a challenging skin condition. The study tests four different doses of LEO 138559 against a placebo (a treatment without the active drug) over 36 weeks. Participants, who will be randomly assigned to one of the doses or placebo, will receive injections just under the skin at regular clinic visits. The trial includes a 4-week screening phase, a 16-week treatment phase, and a 16-week follow-up. Participants will visit the clinic 17 times and keep a daily electronic diary to track their skin condition and quality of life. This study is crucial for understanding how well LEO 138559 works and its safety in treating this persistent skin condition.

    • LEO 138559- new potential medication for atopic dermatitis
  • Investigating lebrikizumab’s safety for severe Atopic Dermatitis patients

    This study investigates the long-term use of Lebrikizumab in adults and teenagers with atopic dermatitis, a serious skin condition. The focus is on determining the safety and effectiveness of Lebrikizumab over a two-year period. Participants who have completed a previous program may join this extension study. The effectiveness of the treatment is measured using several methods, including the EASI score for assessing the severity of the condition, the IGA scale for rating severity, and a scale for measuring itchiness. Additionally, the extent of body coverage by atopic dermatitis is evaluated. Participants are also required to complete a questionnaire about the impact of the skin condition on their daily life.

    • Lebrikizumab
  • Long-term safety & effectiveness of rocatinlimab for atopic dermatitis

    This trial is all about studying a medicine called rocatinlimab for grown-ups and teens with a serious skin disease named atopic dermatitis (AD). The main goal is to see if rocatinlimab is safe and can help over a long period. The research will also check how well people tolerate the medication. The focus is on those who previously benefitted from the medicine, showing an improvement on a scoring system that measures itching levels. This trial falls in the third phase, making it crucial towards verifying the effectiveness and monitoring any adverse effects of the drug.

    • Rocatinlimab
  • Safety and efficacy study of lebrikizumab for atopic dermatitis in children and adolescents

    A clinical trial to test the safety and efficacy of a drug called lebrikizumab in children and adolescents suffering from moderate to severe atopic dermatitis, commonly known as eczema. The study involves participants between the ages of 6 months and 18 years to monitor how well their bodies absorb the drug. Participants receive a saturating dose of the drug, followed by subsequent doses. The number of doses depends on the participant’s weight. The study also includes a control group that will receive a placebo. The effect of the treatment will be measured by various tests, such as the severity index, itch score and quality of life index.

    • Lebrikizumab
  • Exploring the impact of SanaCutan Basiscreme in delaying atopic dermatitis in high-risk children.

    The trial focuses on evaluating a preventive approach for atopic dermatitis, a common skin disease, in high-risk newborns. These selected infants are at an increased risk due to familial history. The trial involves the application of SanaCutan Basiscreme – a moisturizing cream already approved for treating various skin ailments – on their skin twice daily until they reach 6 months old, with some continuing this treatment until the end of their first year. In parallel, a control group is instructed to avoid the use of skincare products. Any skin issues that appear in either group will be documented and medical examination will be performed regularly. The ultimate goal is to observe if the application of the cream can delay the onset of atopic dermatitis symptoms in these children beyond the first 6 or 12 months of their life.

    • SanaCutan Basiscreme