Ophthalmological Adverse Events of Tralokinumab in AD
Atopic DermatitisAtopic dermatitis (AD) is a skin disease characterised by xerosis, pruritus and erythematous plaques. It is common in children (10 to 20%) with an increasing prevalence (multiplied by 2 in 20 years) and begins to develop at 3 months of age. Half of all atopic dermatitis cases disappear by the age of 5, but 10 to 15% of cases persist into adulthood (i.e. about 3.5% of the French adult population). Conventional treatments consist of emollient creams, topical corticosteroid, topical immunomodulators (topical calcineurin inhibitor: tacrolimus) or systemic cyclosporine. However, a proportion of patients (10%) do not respond sufficiently to this therapeutic arsenal. Recent therapies using monoclonal antibodies (biotherapies) are available (DUPILUMAB -anti Interleukin-4 (IL4) antibody and soon TRALOKINUMAB-anti Interleukin-L13 (IL13) antibody). Conjunctivitis is an adverse event reported in patients treated with dupilumab and tralokinumab in clinical trials. Given that baseline ophthalmic comorbidities affect approximately 20% of AD patients, it is crucial to include an evaluation in future prospective real-life longitudinal studies to assess the true incidence of biologic-induced ophthalmic adverse events. No such study is currently available for Tralokinumab. The French group GREAT (GROUPE DE RECHERCHE SUR L'ECZEMA ATOPIQUE) has recently conducted a study on ocular adverse events of dupilumab (DUPI-ŒIL study, I. COSTEDOAT, M. WALLAERT et al, submitted) which included 180 patients followed for at least 4 months. The results show that the majority of dupilumab-induced conjunctivitis is de novo (frequency 18%). Conjunctivitis-type adverse events were also reported at a frequency of 3.0% to 11.0% in the ECZTRA pivotal studies with Tralokinumab. However, the ophthalmological impact of IL13 inhibition remains partially unknown. Further characterisation of ophthalmological adverse events in patients treated with Tralokinumab in real life is needed to provide information for future recommendations (including prioritisation of indications for systemic therapy) and to improve compliance. The primary objective of the TRALO-OEIL study is to determine the frequency of occurrence of ophthalmologic adverse events with TRALOKINUMAB.
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
DermatitisAtopicThis clinical trial serves to look at the effectiveness of SWRB for the treatment of mild to moderate Atopic Dermatitis in patients below the age of 18. Atopic Dermatitis (AD) is a common condition seen in dermatology, paediatric and primary care clinics in Malaysia. AD poses a significant biopsychosocial burden among sufferers and their families. Current management patterns of AD sufferers in South-east Asia mainly involve use of topical moisturizers and topical corticosteroids. Rice bran and products derived from it have been studied regarding their anti-oxidant, nutritional, cholesterol lowering and health promoting properties. However, there are very few studies that have focused on the benefits of SWRB when used topically. SWRB is cost-effective and easily available, while being an under-utilised product. The investigators wanted to study its effectiveness in controlling the signs and symptoms of Atopic Dermatitis when used as a cleanser and topical paste (emollient) as very little is known on this subject. The investigators wish to study participants below 18 years of age with mild and moderate Atopic Dermatitis. The participants will be followed up for four to six (4 - 6) weeks and the clinical features tabulated. This study does not involve any enteral or parenteral administration of SWRB. Neither does it involve any invasive procedures.
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Atopic DermatitisThis Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants...
DermatitisAtopic5 moreThe main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the...
Atopic DermatitisA Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment.
Study to Evaluate Safety & Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild...
Atopic DermatitisThis is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Atopic DermatitisThis is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis
DermatitisAtopicThis study consists of two phases (Phase I and Phase II). Phase II will be conducted sequentially after the safety of SCM-AGH is secured in Phase I. Phase I: Multicenter in Korea, Randomized, Open-label, Parallel arm Phase II: Multicenter in Korea, Double-blind, Placebo-controlled, Parallel arm
A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic...
Atopic DermatitisEczemaA Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic...
Atopic DermatitisPlaque PsoriasisThe purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who If they have Atopic Dermatitis (AD): Have a diagnosis for at least 3 months Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) Have percent Body Surface Area (%BSA) covering 5% up to 40% A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period If they have plaque psoriasis (PsO): Have a diagnosis for at least 6 months Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.