Phase 2 Eczema Trial, Completed NCT04378569 Sponsor: Arcutis Biotherapeutics, Inc. Condition: Eczema
Back to Eczema

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04378569) tested a cream called ARQ-252 on people with hand eczema. A total of 230 participants were enrolled across two groups, called Cohort 1 and Cohort 2. Cohort 1 was a smaller, earlier group of 7 people who received ARQ-252 cream at a 0.3% strength once daily. Cohort 2 was larger, with the remaining participants split across different versions of the cream — different strengths and how often it was applied (once or twice daily) — as well as a "vehicle cream," which is a plain cream containing no active ingredient, used for comparison purposes. The trial was measuring both how participants responded to the cream and any medical events that occurred during the study. The reported data shows that in Cohort 1, out of 7 participants, 1 person experienced at least one adverse event (an unexpected medical occurrence during the study), and no participants experienced a reaction at the application site, a serious adverse event, or notable changes in blood test results. For Cohort 2, the main thing being measured was how many participants reached a score of "clear" or "almost clear" on a 5-point scale that doctors used to rate the severity of hand eczema (where 0 means completely clear and 4 means severe). The reported data shows that at 12 weeks, 23 out of 65 participants receiving the 0.3% cream once daily, 15 out of 61 receiving the 0.3% cream twice daily, and 10 out of 32 receiving the 0.1% cream once daily reached that "clear" or "almost clear" rating. In the combined vehicle cream (plain cream, no active ingredient) group, 16 out of 65 participants reached that same rating. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Eczema Trial, Completed

NCT04378569
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are legally able to make your own decisions and sign a consent form
  • You are 18 years old or older
  • You have been diagnosed with chronic hand eczema that has either lasted more than 3 months, or has come back at least twice in the past 12 months, and has been generally stable for the last 6 weeks
  • Your hand eczema covers at least roughly one-third of a handprint in total across both hands
  • If you are a woman who could become pregnant, you must have negative pregnancy tests at the start of the study, and agree to use highly effective birth control plus a barrier method (such as a condom) during the study and for at least 4 weeks after the last dose
  • If you are a woman who cannot become pregnant, you must either have gone through menopause (no periods for at least 12 months) or have had a surgical procedure to prevent pregnancy
  • If you are a man who has sexual intercourse with a woman who is pregnant or could become pregnant, you must agree to use a condom every time during the study and for 4 weeks after the last dose
  • You are considered to be in good general health, based on a doctor's review of your medical history, physical exam, heart trace (ECG), and blood and urine tests

Who may not be able to join:

  • You have another skin condition on your hands that could interfere with the study results (confirm with trial site)
  • You have ever had or currently have psoriasis
  • You have previously had a positive patch test (allergy skin test) and are still being exposed to that allergen — you must also have had patch testing done within the last 3 years
  • You are unable to stop using current treatments for your hand eczema before and during the study
  • You have had a problem with alcohol or drug misuse in the past 6 months
  • You are pregnant, breastfeeding, or planning to become pregnant during the study or within 28 days of the last dose
  • You have a serious medical condition or significant abnormal test results that a doctor believes would make it unsafe for you to take part

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: David Berk, MD, Arcutis Biotherapeutics, Inc.

Australian sites

Arcutis Clinical Site 306, Westmead, New South Wales
Arcutis Clinical Site 303, East Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Arcutis Biotherapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
20 April 2020
Est. completion
24 February 2021

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Cohort 1: Number of Participants With ≥1 Adverse Event (AE); Cohort 1: Number of Participants With an Application Site Reaction; Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE); Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters; Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters; Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov