A Phase 2 interventional study of 0.5% AR100DP1 and Placebo in Dermatitis Atopic, sponsored by Arjil Pharmaceuticals LLC. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Arjil Pharmaceuticals LLC · Phase 2, Interventional, and Treatment
This study is composed of a two-arm, double-blind, randomized, placebo-controlled, Phase II study to evaluate the efficacy of AR100DP1 compared to placebo on AD lesion area(s) in subjects with mild to moderate AD.
Eligible subjects with mild to moderate AD will have 14 days of treatment with 0.5% AR100DP1 or placebo on all AD lesion area(s). At Screening Visit, all AD lesions will be measured and recorded in cm², and the investigator will identify one or multiple patches of AD lesions with an Investigator's Global Assessment (IGA) score of 1 to 3, and a maximum total treated area of 1,050 cm². For topical administration of IP, AR100DP1 will be applied on all AD lesion area(s) two times a day for 14 days. At subsequent visits, the lesion regions of all applied study IP will be traced, measured, and recorded. If any existing AD lesion expands or a new AD lesion with an IGA score of 1 to 3 is detected during the study period, the investigational product (IP) may continue to be applied, provided that the total treated area does not exceed 1.5 times the total AD lesion area defined on Day 1.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 40 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Arjil Pharmaceuticals LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following serum test abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AD subjects receive 0.5% AR100DP1
Drug: 0.5% AR100DP1
AD subjects receive placebo
Other: Placebo
Investigational drug administered according to the protocol schedule.
Visually identical placebo containing no active ingredient
The change of IGA to 0 or 1 at visit 4 after 14 days treatment
Proportion of subjects with the Investigator's Global Assessment (IGA) score of 0 or 1 at Visit 4 (Day 15).
Time frame: From Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)
Efficacy - the change of IGA
Proportion of subjects achieving the Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)
Time frame: Evaluated at Visit 3 (Day 8), Visit 5 (Day 22), and Visit 6 (Day 29)
Efficacy - the change of lesion area(s) (cm²)
Change from baseline (Visit 2) of lesion area(s) to Visit 3-6
Time frame: Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change of pruritus NRS
Change from baseline (Visit 2) in pruritus NRS(Numerical Rating Scale) of itch level on lesion area(s) to Visit 3-6
Time frame: Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change ≥ 2 points of reduction of pruritus NRS
Proportion of subjects having ≥ 2 points of reduction from baseline (Visit 2) in pruritus NRS for worst itch in the past 24 hours on lesion area(s) to Visit 3-6
Time frame: Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Efficacy - the change of signs of atopic dermatitis
Change from baseline (Visit 2) in signs of atopic dermatitis (erythema, edema/papulation, excoriation, and lichenification) with grading from 0(none) to 3(severe) on lesion area(s) to Visit 3-6
Time frame: Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety- AE and SAE
Incidence of AE and SAE during Visit 2-6 and AE will be categorized by severity (toxicity grade) and relationship to the study intervention
Time frame: Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - change of vital sign
Change from baseline (Visit 2) in vital signs to Visit 3-6
Time frame: Evaluated at Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - abnormality in physical examination occurred
Abnormality in physical examination at Visit 2-6
Time frame: Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - ECG result
Transition of ECG result from normal to abnormal findings from baseline (Visit 2) to Visit 3-6
Time frame: Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - Lab parameters
Change from baseline (Visit 1) in laboratory parameters to Visit 3-6
Time frame: Evaluated at Visit 1 (-14 to -1 Day), (Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Safety - assessment of local tolerability
Proportion of subjects with scores of 0 and 1 in each symptom of assessment of local tolerability (erythema, edema, vesiculation, and excoriation) with grading from 0 (none) to 3 (severe) at Visit 2-6
Time frame: Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Arjil Pharmaceuticals LLC