Atopic Dermatitis study: Roflumilast Cream vs Vehicle Cream
Official title Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT07916480
What this study is testing
What is Roflumilast Cream 0.3%?
Roflumilast Cream 0.3% is an investigational medicine, applied to the skin once daily, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 3 study is designed to look at how well it works and how safe it is of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
You likely can't join if
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
- Pregnant or breastfeeding participants.
See the full eligibility criteria
- Male or female participants aged 6 years and older.
- Clinical diagnosis of moderate to severe atopic dermatitis.
- vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
- EASI score ≥5 at baseline.
- Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
- Able and willing to comply with study procedures.
- Participant or parent/legal guardian able to provide informed consent/assent.
- Uncontrolled medical conditions that could interfere with study participation.
- Skin disorders that may confound study assessments.
- Active infection requiring systemic treatment.
- Known hypersensitivity to roflumilast or formulation components.
- Use of prohibited medications within protocol-defined washout periods.
- Pregnant or breastfeeding participants.
- Participation in another treatment clinical trial within the protocol-defined timeframe.
- Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Bryant, Arkansas, United States
- Miami Lakes, Florida, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Bryant, Arkansas, United States; Miami Lakes, Florida, United States; Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.