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Atopic DermatitisPhase 1/2NCT04369846

A Phase I/IIa Study to Investigate the GM-XANTHO in Healthy Volunteers and Atopic Dermatitis Patients

A Phase 1/2 study testing GM-XANTHO onitment in people with Atopic Dermatitis, run by Xantho Biotechnology Co., LTD at 4 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate its Efficacy and Safety Profile in Atopic Dermatitis Patients Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
GM-XANTHO onitment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
4 sitesTaiwan
Study dates
4 May 2020to 24 Feb 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Phase I Number of patients achieving IGA of 0 or 1 with a ≥2 point improvement in Phase IIa study
  • Female or male, age ≥ 20 years old
  • Subjects whose body mass index (BMI) at screening is within a range of ≥ 18.5 kg/m2 and <30.0 kg/m2.
  • BMI = Body Weight (kg) / [Height (m) × Height (m)]2
  • Subject's medical history shows no contraindication to the test medications.
  • Subjects judged to be in good health by the investigator based upon the results of physical examinations (PEs), electrocardiogram (ECG) test, and all items of routine laboratory tests, including serum biochemistry, hematology and urinalysis, are within normal range as judged by the site. Assessment items of blood biochemistry include albumin, total protein, total bilirubin, ALP, SGOT, SGPT, BUN, serum creatinine. Assessment items of hematology tests include RBC count, WBC with differential counts, hemoglobin, hematocrit and platelet count. Assessment items of urinalysis include pH, color, appearance, gravity, erythrocyte, leukocyte, glucose, protein, ketones and nitrite.
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  • Female subjects show negative pregnancy test results and all male and female subjects with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods as shown in inclusion criteria #12 of phase IIa prior to the first study dose.
  • Subjects did not take any of the following medications in the specified durations:
  • Exposure of test sites to topical medications within 14 days prior to the application of IPs
  • Any systemically-absorbed medication (excluding vitamins, food supplements, and hormone contraceptives for birth control) within 14 days prior to the first dose of the study
  • Any enzyme inducer/inhibitor and/or known hepatic or renal clearance-altering agents within 30 days prior to the first dose of the study
  • Subjects are willing to comply with protocol-stated requirements, instructions and restrictions, followed by understanding and signing the written informed consent form.
  • Phase IIa
  • Female or male, age ≥ 20 years old
  • Subjects who are diagnosed of atopic dermatitis based on the Hanifin and Rajka Criteria.
  • Subjects who are with IGA score between mild (2) to moderate (3) and the Eczema Area and Severity Indices (EASI) are ≤ 20.
  • Subjects who have body surface area of atopic dermatitis involvement ≥2%, ≤ 40% (≤20% if 10% GM-XANTHO would be used).
  • Subjects who agree discontinuation of all treatment modalities, such as topical antihistamines, topical antimicrobials, topical corticosteroid and light treatments during the study treatment period for/on the affected site(s) (except the rescue medication prescribed by the study investigator(s)).
  • Subjects who agree discontinuation of systemic corticosteroids, systemic antihistamines, and systemic immune-modulating agents during the study treatment period (except the standard medication oral antihistamine levocetirizine and rescue medication prescribed by the study investigator(s)).
  • Subjects who are required to stop using treatment drugs listed in criteria# 5 for at least 14 days (or longer if the treatment half-life requires so; 7 half-lives should have elapsed) and treatment drugs listed in criteria# 6 for 28 days before the first investigational drug dose administration.
  • Subjects who are judged to be in general good health (without clinically significant abnormalities) by the Investigator based on medical history, PEs, ECG, and routine laboratory tests at screening.
  • Subjects who stopped immunosuppressant drugs for at least 28 days prior to the first dosing.
  • Subjects who have taken oral antihistamine of levocetirizine 5mg once daily for at least 7 days before initiating the study treatment.
  • Subjects who are eligible and able to participate in the study and accept to enter the study by signing this written informed consent form.
  • If Subjects are male patients or female patients with child-bearing potential (between puberty and 2 years after menopause), subjects should use at least any one of the appropriate contraception methods shown below, for during and at least 4 weeks after GM-XANTHO treatment.
  • Total abstinence (when this is in line with subjects preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, subjects reproductive status should have been confirmed by follow up hormone level assessment.
  • Male sterilization. Female patients' vasectomized male partner should be the sole partner.
  • Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
  • d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception.
  • d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.

Who cannot join

  • Phase I:
  • Subjects with the following conditions at the application site(s) that would interfere with the IP administration, skin assessment, or reaction to IPs:
  • presence of open sores
  • obvious differences in skin color between applications sites
  • excessive hair
  • scar tissue tattoo
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  • coloration
  • Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study
  • Subjects with any diagnosed dermatological or allergic diseases within 180 days prior to the first study dose
  • Subjects with any clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs
  • Subjects had participated in investigational drug trials and took any investigational drug within 60 days prior to the first study dose.
  • Subjects had blood donation for more than 250 mL within 60 days or 500 mL within 90 days prior to the first study dose.
  • Subjects had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.
  • Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first study dose and during the entire study period, and 48 hours after the last dose administration of IPs.
  • Subjects who are inappropriate to participate in this study, as judged by the clinical Investigator
  • Subjects who have been tested positive for the following tests:
  • Human immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV): HBsAg and anti-HBc
  • Hepatitis C virus (HCV)
  • Phase IIa:
  • Subjects who have participated in investigational drug trials and took any investigational drugs within 30 days or within 5 half-lives of the investigational drugs prior to the screening visit.
  • Subjects who have any concurrent skin condition that will interfere with the assessment of treatment.
  • Subjects who have an active infection on the atopic dermatitis site(s) at baseline.
  • Subjects who are inevitable to engage in activities involving excessive or prolonged exposure to sunlight.
  • Subjects who have known hypersensitivity to the study medication.
  • Subjects who are with chronic condition(s) which either is not stable or not well controlled.
  • Subjects who have positive results for HBV, HCV or HIV screens
  • Subjects who are pregnant or breast feeding.
  • Subjects who carry history of malignancy of any organ system (other than cervical carcinoma in situ or localized prostate cancer) within 5 years prior to study entry.
  • Subjects who are not suitable to participate in the trial as judged by the Investigator(s).

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • Ministry of Health and Welfare Shuang-Ho Hospital

    New Taipei City, New Taipei, 235041

  • National Taiwan University Hospital

    Taipei, Taipei, 100225

  • Taipei Medical University Hospital

    Taipei, Taipei, 110301

  • Linkou Chang-Gung Memorial Hospital

    Taoyuan, Taoyuan, 333423

Other trials in Taiwan

About this study

Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate Its Efficacy and Safety Profile in Atopic Dermatitis Patients

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate its Efficacy and Safety Profile in Atopic Dermatitis Patients

Read the detailed description

The Phase I study is randomized, double-blind, placebo-controlled, dose escalating. There will be 3 dose cohorts, 4 (up to 8) subjects will be randomized in a 3:1 (GM-XANTHO to placebo) ratio in each cohort.The total study will take at least 23 days, conducted in National Taiwan University Hospital with 2-24 healthy subjects being enrolled.The Phase IIa study is randomized, double-blind, placebo-controlled, parallel. 2:1 ratio for GM-XANTHO to placebo control. The total study will take at least 43 days, conducted in National Taiwan University Hospital, Taipei Medical University Hospital, Ministry of Health and Welfare Shuang-Ho Hospital, and Linkou Chang-Gung Memorial Hospital with 102 Atopic Dermatitis patients being enrolled.

Being tested
GM-XANTHO onitment, Placebo onitment
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GM-XANTHO onitmentDrug

    Also called Drawing blood

    Onitment application

  • Placebo onitmentDrug

    Also called Drawing blood

    Onitment application

Study groups in NCT04369846
Study groupRoleWhat they receive
Test drug groupExperimentalThe arm applies the test drug of GM-XANTHO
Receives: Drug: GM-XANTHO onitment
Placebo groupPlacebo comparatorThe arm applies the placebo
Receives: Drug: Placebo onitment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment emergent adverse events (TEAEs)

    Number of treatment emergent adverse events (TEAEs) occurring during the Phase I

    Measured: 7 days for Phase I

  2. IGA

    Number of patients achieving IGA of 0 or 1 with a ≥2 point improvement in Phase IIa study

    Measured: 28 days for Phase IIa

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start4 May 2020
  3. Primary completion22 Jan 2025
  4. Study completion24 Feb 2025

Resources

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 1/2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04369846
Sponsor's protocol ID
XANGMXA20160505
Status last verified
Apr 2025
First submitted
28 Apr 2020
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GM-XANTHO onitment in people with Atopic Dermatitis, run by Xantho Biotechnology Co., LTD at 4 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 31 inclusion and 30 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: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment emergent adverse events (TEAEs) (time frame: 7 days for Phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369846.

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 6 Apr 2025.

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