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

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).

Trial ID: NCT04773587

Trial Details

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

Right now, doctors at select US and Canadian centers are conducting a research study that may be able to help. The study is for an investigational eczema cream, applied daily for 4 weeks. If your child (6 to 17 years old) has eczema, they may qualify to participate.

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.

If you have questions about this study or would like to prescreen over the phone, please call: (855) 960-4302

Estimated Enrollment

650 Participants

Phase

3

Eligibility Criteria

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

Check Your Child's Eligibility

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

Get Started

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

You will need to bring your child to one of the study clinics taking part in this clinical trial.

Sites are located in the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

Check Your Child's Eligibility

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

Get Started