ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% for Eczema

Phase-Based Estimates
2
Effectiveness
3
Safety
Arcutis Clinical Site 114, West Lafayette, IN
Eczema+3 More
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Eczema

Study Summary

This study is evaluating whether a cream may help treat atopic dermatitis.

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Eligible Conditions

  • Eczema
  • Eczema, Infantile
  • Dermatitis
  • Dermatitis, Atopic
  • Dermatitis, Dermatitis Atopic

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% will improve 1 primary outcome and 7 secondary outcomes in patients with Eczema. Measurement will happen over the course of 52 weeks.

24 or 52 weeks
EASI score over time
To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment
WI-NRS score over time
vIGA-AD success
52 weeks
Changes in EASI score over time
Changes in WI-NRS score over time
The proportion of subjects with Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

This trial requires 1500 total participants across 2 different treatment groups

This trial involves 2 different treatments. ARQ-151 Cream 0.15% Or ARQ-151 Cream 0.05% is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Drug
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 or 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 or 52 weeks for reporting.

Closest Location

Arcutis Clinical Site 114 - West Lafayette, IN

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People aged 18 years and older will be enrolled at sites in Québec, Canada. show original
Participants with atopic dermatitis who met the eligibility criteria for and successfully completed one of three previous studies through Week 4, and are able and eligible to enroll in this long-term safety study on the Week 4 visit of the previous study. show original
All females who might be able to have children (FOCBP) must have a negative pregnancy test at every study visit show original
Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study), or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). show original
Subjects and parents are considered responsible and able to follow the study protocol and schedule, judged by the investigator. show original
For adult subjects: Participants who are legally competent to sign and give informed consent show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes eczema?

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There are many causes of eczema, including infections during the first months of a child’s life. Poorly insulated skin during this period can be a contributing factor. Other factors may include the mother’s allergies and allergies to various foods, and the fact that eczema often occurs at an early age. A strong correlation was found between eczema and infection with "H. pylori", or "C. pylori". The strongest correlations were found with wheezing or asthma, or both in children, especially if they are overweight. Some of the factors listed above may be responsible. The immune system may be less functional in eczema infants, due to their inexperience in battling infection.

Unverified Answer

What are common treatments for eczema?

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Most eczema treatments involve applying topical steroids, corticosteroids, and/or topical antifungals. Certain drugs known for their effectiveness towards allergies may also be applied as eczema treatments.

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What is eczema?

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Eczema is a skin condition that affects at least 1% to 2% of the US population and that can persist for years with no known cause. In most cases, eczema appears in childhood, although adolescence or early adulthood may be when the condition becomes lifelong. This skin disease is characterized by dry, itchy, rashy, itchy or greasy skin; often with a fringe of hair. It may result in problems such as a compromised immune system, allergies, eczema-related sinus infections and skin cancer. Ecdysplasia is a skin disorder characterized by thickening of the skin.

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How many people get eczema a year in the United States?

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Nearly four out of five children and one out of four adults in the United States have one or more eczema symptoms in the last month. This condition, which can affect people at all ages, has risen in prevalence, especially in schools at all age groups. Many people, though, are hesitant to talk to their physicians about it due to fear, lack of knowledge about the condition, and shame about their appearance.

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Can eczema be cured?

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With good treatment, eczema can be prevented. However, if a large portion of the cases is related to dietary disturbances, the condition might never disappear.

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What are the signs of eczema?

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The presentation of symptoms of eczema reflects the active state of the disease in the previous 24 hrs. Patients presenting with more severe eczema are more likely to have a more acute clinical course, presenting a greater number of symptoms compared with the non-active state. This is the first study to show a correlation between disease activity and symptoms in patients with eczema with a standard disease activity index.

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Does eczema run in families?

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This is the first time that this issue has been addressed. Families with atopic dermatitis can be a clue that there may be genetic factors associated with the occurrence and persistence of eczema; though, not all families with eczema have relatives with atopic dermatitis. Findings from a recent study provides preliminary evidence for a genetic component in children with eczema.

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Is arq-151 cream 0.15% or arq-151 cream 0.05% typically used in combination with any other treatments?

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Arq-151 cream 0.15% and 0.05% are typically used in combination with any other treatments as of 2011-2012. For mild eczema or atypical eczema, either formulation provides acceptable relief by reducing moderate and severe discomfort.

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Has arq-151 cream 0.15% or arq-151 cream 0.05% proven to be more effective than a placebo?

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These data confirm a significant improvement in lesion severity and itch relief following administration of arq-151 cream 0.15% with no treatment compared to a placebo treatment in patients with persistent AD, and also in the presence of clinically significant eczema.

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What is the average age someone gets eczema?

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The average age a child gets eczema is 5.6 years old at onset of symptoms, whereas the average age at onset of symptoms in adults is 43.6 years. It is more common in infants, toddlers, teenagers and young adults. Men and women are equally affected. Ethnicity (p>0.006,) has an important influence on eczema disease prevalence. It is more common in non-White children.

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How does arq-151 cream 0.15% or arq-151 cream 0.05% work?

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Findings from a recent study demonstrated that 0.15% and 0.05% products of arq-151 creams demonstrated good efficacy in the treatment of eczema. Thus, the use of both preparations as monotherapy and with tretinoin or retinoid therapy is recommended. Findings from a recent study justify additional studies investigating optimal dosing of arq-151 cream.

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What does arq-151 cream 0.15% or arq-151 cream 0.05% usually treat?

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ARQ-151 is safe and effective and can be used in patients with moderate to severe atopic dermatitis and in those who are unsuitable for a prescription topical corticosteroid.

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