RecruitingPhase 2interventionalRules rewrite

Phase 2: testing 0.5% AR100DP1 for Dermatitis Atopic

This study is composed of a two-arm, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, Phase II study to measure the how well it works of AR100DP1 compared to dummy treatment (placebo) on AD lesion area(s) in subjects with mild to moderate AD.

Official registry: https://clinicaltrials.gov/study/NCT07914088 · Arjil Pharmaceuticals LLC · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are 0.5% AR100DP1, or Placebo. The registry lists allocation as randomized. This study is composed of a two-arm, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, Phase II study to measure the how well it works of AR100DP1 compared to dummy treatment (placebo) on AD lesion area(s) in subjects with mild to moderate AD.

They plan to enroll about 40 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects With Mild to Moderate Atopic Dermatitis

Interventions: 0.5% AR100DP1, Placebo

Primary outcome (registry wording): The change of IGA to 0 or 1 at visit 4 after 14 days treatment

Who it is for (from inclusion criteria)

Ages 18 Years to any
Either gender, ≥ 18 years old (the legal age of consent majority is 18 years old in Taiwan)
Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)
Clinical diagnosis of AD with clinically consistent and stable disease status, defined as AD lesions with the Investigator's Global Assessment (IGA) score of 1(almost clear) to 3(moderate) for at least 4 weeks prior to Screening Visit, at the investigator's discretion
Not expected to require regular AD maintenance therapy during the study period, at the investigator's discretion
Have AD lesion area(s) with an IGA score of 1 to 3 at the Screening Visit and Day 1, with a maximum total treated area of 1,050 cm², as judged by the Investigator
Have a pruritus NRS score of ≥ 2 for both the average itch and the worst itch in the past 24 hours, as assessed at Screening Visit and Day 1 prior to randomization

Who the registry excludes

Fluctuating or actively infected AD judged by the investigator
Have any AD lesion with an IGA score of 4 at the Screening Visit or Day 1, as judged by the Investigator
History of the following conditions, including irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases
Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator
Received systemic medication including immunosuppressant, phototherapy, or other therapy, which could affect AD within 4 weeks before Day 1
Received systemic antihistamine within 5 half-lives (see Appendix 1 for half-lives of common antihistamine) prior to Day 1 (except for permitted background medication, Fexofenadine)
Received systemic corticosteroid within 2 days or 5 half-lives, whichever is longer, prior to Day 1

Public study contact (from the registry)

Yeh B Wu

+886-3-573-3608

ybw333@arjilbio.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Taipei Medical University Hospital — Taipei, Taiwan, Taiwan (recruiting)
Chang Gung Memorial Hospital-Linkou — Taoyuan, Taiwan, Taiwan (not_yet_recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phasePittsburgh, Pennsylvania

Not a traditional drug phase: Blood draw, skin biopsy or urine collection for Cutaneous T-cell Lymphoma

This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.

NCT00177268 · Official ClinicalTrials.gov record · University of Pittsburgh

RecruitingNot a traditional drug phaseBethesda, Maryland

Studies of Skin Microbes in Healthy People and in People With Skin Conditions

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.

NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Trimethoprim/sulfamethoxazole (TMP/SMZ) for Eczema

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.

NCT01631617 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

FAQ about this NCT record

Is NCT07914088 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07914088?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07914088?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary