tapinarof cream, 1% for Eczema, Infantile

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dermavant Clinical Trial, Huntington Beach, CA
Eczema, Infantile+3 More
tapinarof cream, 1% - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a cream can improve the symptoms of atopic dermatitis.

See full description

Eligible Conditions

  • Eczema, Infantile
  • Dermatitis, Dermatitis Atopic

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Eczema, Infantile

Study Objectives

This trial is evaluating whether tapinarof cream, 1% will improve 1 primary outcome and 4 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Baseline to Week 8.

Baseline to Week 8
Mean change in %BSA affected from Baseline at Week 8
Proportion of subjects who have a vIGA-AD score of clear or almost clear (0 or 1) at Week 8
Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8
Proportion of subjects with ≥ 90% improvement in EASI from Baseline at Week 8
Proportion of subjects ≥ 12 years old with a Baseline PP-NRS score ≥ 4 who achieve ≥ 4-point reduction in the PP NRS from Baseline at Week 8

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Eczema, Infantile

Trial Design

2 Treatment Groups

tapinarof cream
1 of 2
vehicle cream
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tapinarof Cream, 1% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

tapinarof cream
Drug
tapinarof cream, 1%, applied topically once daily
vehicle cream
Drug
vehicle cream, applied topically once daily

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 8 for reporting.

Closest Location

Dermavant Clinical Trial - Huntington Beach, CA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Most children who have atopic dermatitis, a skin condition marked by inflamed, itchy skin, have it for more than 6 months show original
Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Individuals who have atopic dermatitis that covers 5% to 35% of their body surface area are considered to have a mild form of the condition. show original
is associated with a significant increase in risk of major cardiovascular events show original
was associated with a significantly increased risk of mortality show original
Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
This text means that you are not allowed to be pregnant. show original
The text discusses research on the impact of AD on male and female subjects aged 2 and above show original

Patient Q&A Section

What is eczema, infantile?

"Eczema, infantile has a strong family history of more than 1 in 300 children. In our hospital, 85% with eczema, infantile required at least 1 corticosteroid therapy in order to resolve. Eczema, infantile should be included in the differential diagnosis of children with persistent rashes. The severity of eczema, infantile should be assessed as promptly as possible because of its close association with asthma. The condition is associated with recurrent infections. Effective treatment with immunostimulatory therapy may improve the prognostic result." - Anonymous Online Contributor

Unverified Answer

What are common treatments for eczema, infantile?

"Eczema is associated with a significant degree of symptomatology. The treatment of eczema is typically symptom based; topical corticosteroids are used to control itchiness and relieve discomfort. There are numerous topical and oral medications for psoriasis. Treatment for psoriasis is also symptom based and includes corticosteroids, topical and oral medications, and phototherapy. A systematic review from 2000 suggested that topical corticosteroids are efficacious in mild to moderate eczema. There is tentative evidence that immunosuppressant medications may provide a short-term reduction in flares. However, long-term treatment must be weighed up against the risks of side effects." - Anonymous Online Contributor

Unverified Answer

What are the signs of eczema, infantile?

"This condition is typically diagnosed in infancy. It is important to note that the most common presenting symptoms are pruritic scaly eczema of childhood and atopic dermatitis in infancy. Other symptoms include abnormal scars, red eyes, and cough. Symptoms may worsen with hot or humid weather, stress, and fatigue. Those with eczema of infancy should use the PowerSite database to find clinical trials that are tailored to their condition." - Anonymous Online Contributor

Unverified Answer

Can eczema, infantile be cured?

"There appears to be a high incidence of the symptoms (worse in the early stages) of eczema in children with chronic eczema (that is not due to a physiological abnormality such as atopic dermatitis) and, in our hands at St Mark's Hospital, a high incidence of a family history of autoimmune disease. We have therefore been able to identify a child with eczema and an increased risk of autoantibodies, which is suggestive of autoimmune disease. We conclude that there is evidence that eczema in some children with chronic eczema can be due to an autoimmune abnormality." - Anonymous Online Contributor

Unverified Answer

What causes eczema, infantile?

"The pathogenesis of eczema is still unclear. Genetic and/or environmental factors are responsible for a significant proportion of the variance. The most likely environmental risk factors are stress, the presence of certain micro-organisms, and exposure to tobacco smoke in utero. Some of these factors are also thought to be involved in the pathogenesis of eczema in adults. Further research is necessary to elucidate the etiology of eczema, and to develop strategies for prevention and treatment." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 7.8 million children are diagnosed with at least one chronic allergic disease at least once a year in the United States. Children with eczema have the highest odds of being diagnosed with at least one other chronic allergic disease, which occurs during adolescence (OR=3.36). Younger age of onset increases the likelihood of being diagnosed with any or a combination of three other allergies (OR=6.38-12.5), and/or allergic asthma (OR=5.14). Asthma is the most common chronic allergic disease seen in children with at least one of the other two allergies. Children with other allergic manifestations are less likely to be diagnosed with asthma than children without them." - Anonymous Online Contributor

Unverified Answer

What is the latest research for eczema, infantile?

"There is a new avenue for research into the biology of eczema, and much is being learned with the use of genetics and genomics. We are even discovering new ways to classify and diagnose eczema. Research for eczema can be accessed at [Power (http://power.withpowerweb.com)], but one has to be willing to wait for 4 or 5 years to see the results." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tapinarof cream, 1% for therapeutic use?

"Tapinarof cream had not been updated in 1 year, and the composition of the product had not been changed. The label stated that the product was approved for use by the US Food and Drug Administration. These indications that the label claimed may have been incorrect." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for eczema, infantile?

"Data from a recent study of the current study show that trials of topical corticosteroids are effective, warranting an urgent trial, for eczema of both toddlers and infants because these are the main group for which topical corticosteroids are available. For eczema patients with suspected allergy to corticosteroids, the recent results of a trial of omalizumab support the view that omalizumab has a beneficial effect." - Anonymous Online Contributor

Unverified Answer

What is tapinarof cream, 1%?

"Tapinarof cream, 1%, is an effective, light to medium-acting, viscous emollient used in the treatment of mild-to-moderate atopic dermatitis for at least 8 weeks. The presence of a prescription or over-the-counter medicine or product should be stated on all application instructions." - Anonymous Online Contributor

Unverified Answer

Does eczema, infantile run in families?

"Although the exact causal relationship between eczema, infantile, and eczema, infantile is still unknown, ECZ is a disorder of the skin that involves allergic sensitization to environmental triggers and should be investigated further among families with ECZ, infantile eczema, and ECZ, infantile." - Anonymous Online Contributor

Unverified Answer

Is tapinarof cream, 1% safe for people?

"Most people feel the product is well-tolerated, although the application technique may be problematic for some. The product can be used safely in a paediatric setting with a thorough explanation about why it is recommended during a topical consultation." - Anonymous Online Contributor

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