Clinical Research Directory

Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

This is a research study. The over-the-counter (OTC) drug for atopic dermatitis being tested is not approved as a treatment for the participants' atopic dermatitis condition. In participating in this study, the investigators will analyze the participants' skin microbiome, measure skin hydration and barrier function, and assess clinical improvements to help us understand the potential impact of the investigational OTC drug on atopic dermatitis and skin microbiome balance.

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

The goal of this observational registry is to characterize the clinical features, severity, treatments, and outcomes of patients with atopic dermatitis in Costa Rica receiving systemic and advanced therapies in routine clinical practice. The main questions it aims to answer are: What are the demographic and clinical characteristics of patients with moderate-to-severe atopic dermatitis treated in specialized dermatology centers in Costa Rica? What treatments are used in real-world practice and how do they impact disease severity and patient-reported outcomes over time? Participants with atopic dermatitis receiving systemic or advanced therapies as part of their usual medical care will be followed longitudinally, with collection of clinical severity scores, treatment patterns, and outcomes during routine visits.

A Study Evaluating BFB759 in Moderate to Severe Atopic Dermatitis

This is a double-blind, placebo-controlled study where subjects are participating for approximately 36 to 40 weeks. The study compares how well BFB759 works and how safe it is compared with a placebo.

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

The goal of this clinical trial is to learn about the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis. The main questions it will answer are: * Is there an impact on the severity and area of atopic dermatitis when participants take ENV-294 * What medical problems do participants have when taking ENV-294 Researchers will review the atopic dermatitis present at the beginning of the study against the atopic dermatitis present at the end of the study. Participants will: * Take drug ENV-294 or a placebo once every day for 12 weeks * Visit the clinic every 2 to 4 weeks for checkups and tests * Keep a diary of their symptoms and when they took their study drug ENV-294 * Return to the clinic for the final study visit at approximately week 16

A Pilot Study on the Efficacy of 2% Cholesterol Cream in Preventing Transepidermal Water Loss and Clinical Symptoms in Mild to Moderate Atopic Dermatitis

Atopic dermatitis is a common chronic inflammatory skin condition characterized by impaired skin barrier function, leading to increased transepidermal water loss (TEWL), dry skin, and itching. Restoration of the skin barrier is an important component of treatment. Cholesterol is a key lipid in the stratum corneum that plays a role in maintaining skin barrier integrity. This study aims to evaluate the efficacy and safety of 2% cholesterol cream in improving skin barrier function and clinical symptoms in patients with mild to moderate atopic dermatitis aged 7-17 years. Participants will be randomly assigned to receive either 2% cholesterol cream or a placebo (cream base), applied twice daily for 12 weeks. Outcomes will include measurements of transepidermal water loss (TEWL), skin hydration, skin pH, Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus numeric rating scale (NRS). The results of this study may support the use of cholesterol-containing topical formulations as a safe and effective treatment option for atopic dermatitis.

A Phase 1 Study of GS101 Injection

This is a randomized, double-blind, three-arm, parallel-group study designed to demonstrate the similarity of the pharmacokinetics (PK), safety, and immunogenicity of GS101 injection compared with U.S. commercial Dupixent® and CN commercial Dupixent® in healthy adult participants in China. A total of 294 healthy male adult participants, with 98 participants per treatment group across 3 groups.

Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234

This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.

Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema

This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.

Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease

This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).

Safety, Tolerability and PK of ATTO-1310 in Healthy Volunteers and Patients With Atopic Dermatitis and Patients With Chronic Pruritus

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.

A Phase III Study of GS101 Injection to Dupixent®

This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®

The Impact of Botox on Neuroimmune Interactions in Atopic Dermatitis

The purpose of this study is to understand cellular and molecular interactions in the skin of participants with mild-to-moderate AD, and how botulinum toxin alters these interactions.

Exploratory Clinical Investigation on Neurosensory Responses Via EEG Headband in Adults With Mild to Moderate Atopic Dermatitis After Application of Marketed Product Compared With Placebo (Water Application).

This is a prospective, exploratory, double-blind, single-visit internal validation study designed to evaluate neurosensory responses using electroencephalography head band (EEG) in adult subjects with mild to moderate atopic dermatitis (AD) following a single topical application of marketed product compared with placebo (water application).

Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VC005 in Adolescent Subjects With Mild to Moderate Atopic Dermatitis

This is a single arm, and open-label phase I study

Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis

Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as "self-reactive antibodies" or "autoantibodies". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate. This study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema. The study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months. This study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and/or serve as predictive factors for the development of atopic eczema.

A Study for HSK44459 in Participants With Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis

The goal of this clinical trial is to study the drug LPX-TI641 in patients with atopic dermatitis and psoriasis. We will compare the safety and tolerability of LPX-TI641 to placebo ( a look-alike solution) that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)

Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function

The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.

Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults

Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD. This study aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence. It is expected that there will be no additional burden for participants in this trial.

Moisturization and Skin Hydration Study

Skin moisturization is important for patients with atopic dermatitis, commonly known as eczema. Moisturizing right after bathing is widely accepted as the best method to keep skin hydrated. However, there is conflicting research on the timing of moisturizing. The goal of this clinical study is to evaluate the preference of moisturizing while showering/bathing compared to after towel drying in adolescents aged 12-18 with eczema. The main question it aims to answer are: * Which moisturization technique is preferred: while showering/bathing or after towel drying? * How do these techniques affect investigator-assessed eczema severity, patient-reported itch scores, and objective skin hydration measurements? Researchers will compare applying moisturizer while in the shower/bath to after towel drying and to which technique is preferred among participants and if there are different effects on eczema and skin hydration. Participants will: * Apply moisturizer while showering/bathing for one month and after towel drying for one month. * Complete questionnaires on moisturization technique, skin feel, and itchiness. * Undergo skin hydration measurements using a Corneometer® CM825 device.

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-7624 in Healthy Adult Participants

This is a randomised, double-blinded, placebo-controlled first in human (FIH) trial to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity of GB-7624. The trial will have two parts: a SAD component and a MAD component. Part A (SAD): a total of 24 healthy volunteers are planned to be enrolled across 3 SAD cohorts and will involve the administration of a single subcutaneous (SC) dose of GB-7624 (300 mg, 600 mg, or 1200 mg) or placebo on Day 1 in cohorts A1, A2, and A3. Part B (MAD): a total of 16 healthy volunteers are planned to be enrolled across 2 MAD cohorts and will involve the administration of multiple SC doses of GB-7624 (300 mg on Day 1 and Day 15 or 600 mg on Day1 and Day 15) or placebo in cohorts B1 and B2. The decision to escalate between dose levels in the SAD (Part A) and the MAD (Part B) as well as the decision to proceed from Part A to Part B will be based on safety review committee (SRC) review of prior cohorts, blinded available safety, tolerability and PK data. Study drug will be administered at the study site by trained study site personnel to ensure compliance. The administration of all trial intervention will be recorded in eCRF. Compliance will be assured by direct supervision and witnessing of trial intervention administration.

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

The goal of this clinical trial is to evaluate the protective effect of glycomacropeptide on the clinical signs and symptoms of atopic dermatitis in children aged 2 to 12 years, and to determine if topical administration of glycomacropeptide is associated with a lower colonization by Staphylococcus species on the skin. The main questions that it aims to answer are: * Does glycomacropeptide reduce the signs and symptoms related to atopic dermatitis in the pediatric population? * Does glycomacropeptide modify the colonization of Staphylococcus species in atopic dermatitis lesions in the pediatric population? Researchers will compare an emollient cream containing glycomacropeptide with an emollient cream without glycomacropeptide to evaluate whether treatment with glycomacropeptide achieves a greater reduction in the clinical severity and pruritus of atopic dermatitis and a lower bacterial colonization compared with the exclusive use of emollients. Participants will: * Read and sign the informed consent * Undergo a prick test at the first visit to ensure no reaction to the treatment components * Receive the assigned treatment (glycomacropeptide cream or emollient cream), which must be applied twice daily only to atopic dermatitis lesions. * Visit the clinic once a week for 4 weeks for follow-up and SCORAD assessments, and for skin sample collection by stripping at first and last visit.

Safety, Tolerability and PK of ATTO-3712 in Healthy Volunteers and Patients With Atopic Dermatitis

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-3712 in healthy adults and patients with atopic dermatitis. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-3712? How long does ATTO-3712 stay in the body after dosing? Researchers will compare ATTO-3712 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-3712 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.