Dermatitis AtopicPhase 2NCT07914088
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis
A Phase 2 study testing 0.5% AR100DP1 in people with Dermatitis Atopic, run by Arjil Pharmaceuticals LLC at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- 0.5% AR100DP1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesTaiwan
- Study dates
- 21 Oct 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dated and signed informed consent
- 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
- Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration
Who cannot join
- 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)
Show all 28Show fewer
- Received systemic corticosteroid within 2 days or 5 half-lives, whichever is longer, prior to Day 1
- Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD lesion area(s) within 1 week before Day 1
- Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine)
- Unwilling or unable to comply with the criteria in Life Style Guidelines (Section 5.3) during the study
- History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1
- Received any other investigational drug within 4 weeks prior to Day 1
- Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to Day 1, including but not limited to clarithromycin, itraconazole, nefazodone, and atazanavir, evaluated by the investigator
- Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before Day 1
- Had surgery within 4 weeks prior to Day 1, or plan to have surgery during the study.
- Known hypersensitivity to any of the components of the study drug
- Active clinically serious infection or any known history of immunodeficiency, including human immunodeficiency virus (HIV) infection
- Current uncontrolled asthma
- Any of the following serum test abnormalities:
- Total bilirubin > 1.5 × ULN
- AST or ALT > 3.0 × ULN
- Serum albumin < 2.5 g/dL
- Creatinine > 1.5 × ULN
- Any other ≥ Grade 2 (grading of NCI-CTCAE v6.0) laboratory abnormality at baseline (other than those listed above)
- With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject who is lactating or has positive urine pregnancy test at Screening and Day 1
- Other conditions not suitable for participating in this study judged by the investigator
- Plan to donate blood, sperm, or eggs from Screening Visit until Final Visit
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, Taiwan, 110
Ming-Hsiu Lin, +886-2-2737-2181, mailto:minghsiu@tmu.edu.tw
- Not yet recruiting
Chang Gung Memorial Hospital-Linkou
Taoyuan, Taiwan, 333
Chun-Bing Chen, +886-3-3281200, chunbing.chen@gmail.com
About this study
Official title: A Phase II Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects With Mild to Moderate Atopic Dermatitis
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.
Read the detailed description
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.
- Conditions
- Dermatitis Atopic
- Being tested
- 0.5% AR100DP1, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% AR100DP1Drug
Investigational drug administered according to the protocol schedule.
PlaceboOther
Visually identical placebo containing no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 0.5% AR100DP1 | Experimental | AD subjects receive 0.5% AR100DP1 Receives: Drug: 0.5% AR100DP1 |
| Placebo | Placebo comparator | AD subjects receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)
Secondary outcomes (11)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Evaluated at Visit 2 (Day 1), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start21 Oct 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjil Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914088
- Sponsor's protocol ID
- AR100DP1-02
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07914088
- Acronym / sponsor ID
- AR100DP1-02
- Conditions
- Dermatitis Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Arjil Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% AR100DP1 | Experimental | Drug: 0.5% AR100DP1AD subjects receive 0.5% AR100DP1 |
| Placebo | Placebo comparator | Other: PlaceboAD subjects receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Dated and signed informed consent
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% AR100DP1Investigational drug administered according to the protocol schedule. | Drug | 0.5% AR100DP1 |
| PlaceboVisually identical placebo containing no active ingredient | Other | Placebo |
Primary outcome
The change of IGA to 0 or 1 at visit 4 after 14 days treatment
Time frame: From Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)
Proportion of subjects with the Investigator's Global Assessment (IGA) score of 0 or 1 at Visit 4 (Day 15).
11 secondary outcomes
Efficacy - the change of IGA
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)
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
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
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
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
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
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
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
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% AR100DP1 in people with Dermatitis Atopic, run by Arjil Pharmaceuticals LLC at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeh B Wu (+886-3-573-3608, ybw333@arjilbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of IGA to 0 or 1 at visit 4 after 14 days treatment (time frame: From Visit 2 (Day 1) to Visit 4 (Day 15) (14 days treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.