Atopic Dermatitis (Eczema) Clinical Trial

Does Your Child Have Eczema?

If your child (6 to 17 years old) has eczema, they may qualify to participate in a research study. The study is for an investigational eczema cream, applied daily for 4 weeks.

Check Your Child’s Eligibility

If your child joins the study, they will receive all study-related care at no cost from a local doctor. You may also be reimbursed for your time and travel to attend study visits.

Millions of kids and adults struggle with eczema (atopic dermatitis) and the constant battle against skin irritation.

Study Information

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

This study will assess the safety and effectiveness of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Eligibility Criteria 

Participants Must:

  • Be 6 to 17 years old at time of screening.

  • Have been diagnosed with atopic dermatitis for at least 3 months.

  • Have had the disease for the past 4 weeks with no major flares up in atopic dermatitis before or at screening.
  • Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening and a negative urine pregnancy test at Day 1, and at every visit to the clinic. In addition, sexually active females must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.

We’ll check to see if your child is eligible by asking you some questions.

Participants Must NOT:

  • Have any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
  • Have unstable AD or any consistent requirement for high potency topical steroids.
  • Use tanning beds or other artificial light emitting devices and have prolonged periods of sun exposure for 4 weeks prior and during the study.
  • Be pregnant, wish to become pregnant during the study, or are breast-feeding.
  • Have had previous treatment with ARQ-151.
  • Have a history of chronic alcohol or drug abuse within 6 months prior to Screening.

Why Participate

If your child (6 to 17 years old) has eczema, they may qualify for a local clinical research study. The study is for an investigational eczema cream, applied daily for 4 weeks. By joining the study, you will receive:

  • Evaluations of your child’s eczema condition from a local doctor
  • Study-related care and medication at no cost (insurance is not required)
  • Reimbursement for time and travel for attending study visits

Like many skin conditions, eczema can also take a toll on self-esteem, causing sufferers to feel embarrassed or self-conscious. And although there are treatment options available, they do not work for everyone.

Frequently Asked Questions

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by local regulatory authorities. These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

If you choose to join the study, your child will receive all study-related care and medication at no cost. Health insurance is not required to participate.

Yes, you may be reimbursed for your travel to attend study visits. Your local study center will be able to discuss these details with you.

As part of the study, participants will be randomly assigned (by chance) to use either the active investigational cream (67% chance) or an inactive cream (33% chance) for a 4 week period. The inactive cream looks just like the investigational cream, but has no active ingredient. Neither your child nor the study doctor will know which cream your child receives. This is a common technique in clinical studies, as it helps researchers understand the effects of the investigational medication without bias. After this 4 week period, participants who still qualify will be offered the chance to receive the active investigational cream for an additional 6 months – there is no inactive cream during this period.

The primary study lasts up to 2 months. During this time, your child will meet with the study doctor a total of 5 times. These visits are an important part of the study, as they allow the study doctor to closely monitor your child’s eczema symptoms, and also discuss the overall experience. You may also be compensated for your time and travel to attend these study visits.

At every visit, your child will be asked about how they are feeling, and their study doctor will examine your child’s skin and eczema symptoms. The study team will also review with you how to apply the study medication. At 3 of the visits, your child will also receive a brief physical exam. In addition, at 3 of the visits your child (if 12 years old and older) will provide a routine blood sample for safety tests. Otherwise, if your child is between 6 and 12 years old your child will provide only 1 routine blood sample at the beginning of the study. Before you decide to participate, the study team will provide you with a detailed summary of what will happen at each visit, so that you and your child can make an informed decision about joining the study.

You can check if your child is potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

As with all clinical studies, participation is completely voluntary. Your child may leave the study at any time without any effect on future medical care.

Please contact your local study center, and they will work with you to schedule a convenient time for the initial visit.

Check Your Child’s Eligibility