Clinical Trials List
Protocol NumberAR100DP1-02
NCT Number(ClinicalTrials.gov Identfier)N/A
Not yet recruiting
2026-07-01 - 2027-12-31
Phase II
Not yet recruiting1
A phase II, double-blind trial was conducted to determine the safety, tolerability, and efficacy of AR100DP1 in subjects with mild to moderate atopic dermatitis.
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Trial Applicant
ComboTrial Consultancy Ltd .
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2026/09/21
Investigators and Locations
Co-Principal Investigator
- Hsiou Hsin Tsai Division of Dermatology
- Tsung-Ju Lee Division of Dermatology
- 張華景 Division of Dermatology
- 李采暹 Division of Dermatology
Principal Investigator
Chun-Bing Chen
Co-Principal Investigator
- Wen-Hung Chung Division of Dermatology
- Hua-En Lee Division of Dermatology
- Chun-Wei Lu Division of Dermatology
- Chin-Yi Yang Division of Dermatology
- 紀敏慧 Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
- 葛宗昀 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Atopic dermatitis
Objectives
Primary objective: To evaluate the efficacy of AR100DP1 in treating atopic dermatitis in subjects.
Secondary objective: To evaluate the safety, tolerability, and efficacy of AR100DP1 in subjects with mild to moderate atopic dermatitis.
Test Drug
AR100DP1
Active Ingredient
Dosage Form
Dosage
0.10 grams / 20 grams (0.5%)
Endpoints
The proportion of participants with an Investigator Overall Rating (IGA) score of 0 or 1 at the 4th visit.
Inclution Criteria
(1) Sign and date the participant's consent form.
(2) Regardless of gender, participants must be at least 18 years old (the legal age of consent in Taiwan is 18).
(3) A clinical diagnosis of atopic dermatitis must be confirmed (based on the diagnostic criteria for atopic dermatitis established by Hanifin and Rajka).
(4) The trial administrator determines that the atopic dermatitis has reached a consistent and stable clinical diagnosis, meaning that the Investigator’s Global Assessment (IGA) score maintained at 1 (virtually cleared) to 3 (moderate) for at least 4 weeks prior to the screening visit.
(5) The trial administrator determines that maintenance treatment for atopic dermatitis is not expected during the trial.
(6) The trial administrator determines that, at the screening visit and on Day 1, the IGA score of the atopic dermatitis lesion area must be between 1 and 3, with a maximum total treated area of 1,050 square centimeters. (7) At the screening visit prior to randomization and at the assessment on Day 1, both scores on the Numerical Rating Scale for Itching (mean itch and most severe itch) over the past 24 hours must be ≥ 2.
(8) Participants of childbearing potential must agree to abstain from sex or use highly effective contraception from the date of signing the participant consent form until 14 days after the last application of the investigational medication.
Highly effective contraception is defined as having an annual contraceptive failure rate of less than 1%. Participants of childbearing potential should use at least one highly effective contraceptive method or a combination of two acceptable contraceptive methods during the trial period. An acceptable method of contraception may include any of the following:
- Intrauterine device (IUD) or intrauterine system (IUS);
- Bilateral tubal occlusion;
- Implantable progestin-containing contraceptive pills that inhibit ovulation;
- The partner has undergone vasectomy;
Or, a combination of two acceptable methods of contraception may include any of the following:
- Combined hormonal contraceptive pills containing estrogen and progestin that work by inhibiting ovulation, including oral, vaginal, or transdermal administration;
- Hormonal contraceptive pills containing progestin that inhibit ovulation, including oral or injectable administration;
- Barrier methods of contraception, including condoms (preferably used in conjunction with spermicide), diaphragms, and cervical/vaginal caps.
(2) Regardless of gender, participants must be at least 18 years old (the legal age of consent in Taiwan is 18).
(3) A clinical diagnosis of atopic dermatitis must be confirmed (based on the diagnostic criteria for atopic dermatitis established by Hanifin and Rajka).
(4) The trial administrator determines that the atopic dermatitis has reached a consistent and stable clinical diagnosis, meaning that the Investigator’s Global Assessment (IGA) score maintained at 1 (virtually cleared) to 3 (moderate) for at least 4 weeks prior to the screening visit.
(5) The trial administrator determines that maintenance treatment for atopic dermatitis is not expected during the trial.
(6) The trial administrator determines that, at the screening visit and on Day 1, the IGA score of the atopic dermatitis lesion area must be between 1 and 3, with a maximum total treated area of 1,050 square centimeters. (7) At the screening visit prior to randomization and at the assessment on Day 1, both scores on the Numerical Rating Scale for Itching (mean itch and most severe itch) over the past 24 hours must be ≥ 2.
(8) Participants of childbearing potential must agree to abstain from sex or use highly effective contraception from the date of signing the participant consent form until 14 days after the last application of the investigational medication.
Highly effective contraception is defined as having an annual contraceptive failure rate of less than 1%. Participants of childbearing potential should use at least one highly effective contraceptive method or a combination of two acceptable contraceptive methods during the trial period. An acceptable method of contraception may include any of the following:
- Intrauterine device (IUD) or intrauterine system (IUS);
- Bilateral tubal occlusion;
- Implantable progestin-containing contraceptive pills that inhibit ovulation;
- The partner has undergone vasectomy;
Or, a combination of two acceptable methods of contraception may include any of the following:
- Combined hormonal contraceptive pills containing estrogen and progestin that work by inhibiting ovulation, including oral, vaginal, or transdermal administration;
- Hormonal contraceptive pills containing progestin that inhibit ovulation, including oral or injectable administration;
- Barrier methods of contraception, including condoms (preferably used in conjunction with spermicide), diaphragms, and cervical/vaginal caps.
Exclusion Criteria
(1) Atopic dermatitis is in a fluctuating or infectious state, according to the investigator's assessment.
(2) Atopic dermatitis lesions with an Investigator's Global Assessment (IGA) score of 4, according to the investigator's assessment.
(3) A history of irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases, according to the investigator's assessment.
(4) Other non-atopic dermatitis that may affect the assessment of the investigational drug, and which may confound the assessment of activity or have a potential for recurrence (e.g., fungal infection), according to the investigator's assessment.
(5) Systemic drug therapy that may affect atopic dermatitis, including immunosuppressants, phototherapy, or other therapies, received within 4 weeks prior to Day 1.
(6) Systemic antihistamines received within 5 half-lives prior to Day 1 (excluding permitted background medication, fexofenadine). (For the half-lives of common antihistamines, please refer to Appendix 1 of the study proposal.) (7) Received systemic corticosteroids within 2 days or 5 half-lives (whichever is longer) prior to Day 1.
(8) Used topical medications, including corticosteroids, immunosuppressants, antihistamines, phototherapy, calcineurin inhibitors, or other treatments, on the affected area of atopic dermatitis within 1 week prior to Day 1.
(9) Planned use of immunosuppressants (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine).
(10) Unwilling or unable to comply with lifestyle guidelines during the trial.
(11) Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
(12) Received any other investigational drug within 4 weeks prior to Day 1. (13) As assessed by the trial administrator, the patient must have used or has used a potent systemic CYP3A4 inhibitor within one week prior to Day 1, including but not limited to clarithromycin, itraconazole, nefazodone, and atazanavir.
(14) Within five years prior to Day 1, the patient has received any type of cancer treatment (excluding squamous cell carcinoma, basal cell carcinoma, or cutaneous carcinoma in situ, which is a curative treatment involving only cryosurgery or surgical excision).
(15) Within four weeks prior to Day 1, the patient has undergone surgery or plans to undergo surgery during the trial.
(16) The patient has a known allergy to any component of the investigational drug.
(17) The patient is currently in a clinically severe infectious state or has a history of immunodeficiency, including a history of human immunodeficiency virus (HIV) infection.
(18) The patient's asthma is currently not stably controlled.
(19) Any of the following serum test values are abnormal:
• Total bilirubin > 1.5 times the upper limit of normal;
• Aspartate transaminase or alanine transaminase > 3.0 times the upper limit of normal;
• Serum albumin < 2.5 g/dL;
• Creatinine > 1.5 times the upper limit of normal;
• Any laboratory abnormality at the baseline period that is ≥ Grade 2 (according to Common Adverse Event Evaluation Criteria (CTCAE) version 6.0) (other than those listed above);
(20) Having a persistent acute illness or a serious medical condition (such as comorbidities) within the past 2 years, such as: cardiovascular disease (e.g., New York Heart Association (NYHA) Grade III or IV), liver problems (e.g., cirrhosis grade C), psychotic state (e.g., alcoholism, substance abuse), medical history, physical examination, or abnormal laboratory values that, as determined by the trial administrator, may interfere with the trial results or adversely affect the safety of the subjects.
(21) Female subjects who are breastfeeding or pregnant at screening time and on day 1 have a positive urine test. (22) The trial administrator assessed that the patient has other conditions that make them unsuitable to participate in this trial.
(23) The patient plans to donate blood, sperm, or eggs during the period from the screening visit to the final visit.
(2) Atopic dermatitis lesions with an Investigator's Global Assessment (IGA) score of 4, according to the investigator's assessment.
(3) A history of irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases, according to the investigator's assessment.
(4) Other non-atopic dermatitis that may affect the assessment of the investigational drug, and which may confound the assessment of activity or have a potential for recurrence (e.g., fungal infection), according to the investigator's assessment.
(5) Systemic drug therapy that may affect atopic dermatitis, including immunosuppressants, phototherapy, or other therapies, received within 4 weeks prior to Day 1.
(6) Systemic antihistamines received within 5 half-lives prior to Day 1 (excluding permitted background medication, fexofenadine). (For the half-lives of common antihistamines, please refer to Appendix 1 of the study proposal.) (7) Received systemic corticosteroids within 2 days or 5 half-lives (whichever is longer) prior to Day 1.
(8) Used topical medications, including corticosteroids, immunosuppressants, antihistamines, phototherapy, calcineurin inhibitors, or other treatments, on the affected area of atopic dermatitis within 1 week prior to Day 1.
(9) Planned use of immunosuppressants (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine).
(10) Unwilling or unable to comply with lifestyle guidelines during the trial.
(11) Received biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
(12) Received any other investigational drug within 4 weeks prior to Day 1. (13) As assessed by the trial administrator, the patient must have used or has used a potent systemic CYP3A4 inhibitor within one week prior to Day 1, including but not limited to clarithromycin, itraconazole, nefazodone, and atazanavir.
(14) Within five years prior to Day 1, the patient has received any type of cancer treatment (excluding squamous cell carcinoma, basal cell carcinoma, or cutaneous carcinoma in situ, which is a curative treatment involving only cryosurgery or surgical excision).
(15) Within four weeks prior to Day 1, the patient has undergone surgery or plans to undergo surgery during the trial.
(16) The patient has a known allergy to any component of the investigational drug.
(17) The patient is currently in a clinically severe infectious state or has a history of immunodeficiency, including a history of human immunodeficiency virus (HIV) infection.
(18) The patient's asthma is currently not stably controlled.
(19) Any of the following serum test values are abnormal:
• Total bilirubin > 1.5 times the upper limit of normal;
• Aspartate transaminase or alanine transaminase > 3.0 times the upper limit of normal;
• Serum albumin < 2.5 g/dL;
• Creatinine > 1.5 times the upper limit of normal;
• Any laboratory abnormality at the baseline period that is ≥ Grade 2 (according to Common Adverse Event Evaluation Criteria (CTCAE) version 6.0) (other than those listed above);
(20) Having a persistent acute illness or a serious medical condition (such as comorbidities) within the past 2 years, such as: cardiovascular disease (e.g., New York Heart Association (NYHA) Grade III or IV), liver problems (e.g., cirrhosis grade C), psychotic state (e.g., alcoholism, substance abuse), medical history, physical examination, or abnormal laboratory values that, as determined by the trial administrator, may interfere with the trial results or adversely affect the safety of the subjects.
(21) Female subjects who are breastfeeding or pregnant at screening time and on day 1 have a positive urine test. (22) The trial administrator assessed that the patient has other conditions that make them unsuitable to participate in this trial.
(23) The patient plans to donate blood, sperm, or eggs during the period from the screening visit to the final visit.
The Estimated Number of Participants
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Taiwan
48 participants
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Global
48 participants
