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Testing Roflumilast cream for treating atopic dermatitis

A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients with Mild to Moderate Atopic Dermatitis

Phase 3 Interventional Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · NCT06631170

This study is testing if Roflumilast cream can help people with mild to moderate atopic dermatitis feel better compared to a regular cream.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment351 (estimated)
Ages6 Years and up
SexAll
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Industry-sponsored
Locations61 sites (Wuhu, Anhui and 60 other locations)
Trial IDNCT06631170 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Roflumilast cream compared to a vehicle cream in patients with mild to moderate atopic dermatitis. Participants will apply either the Roflumilast cream or the vehicle once daily for four weeks. The study is designed as a parallel group, double-blind, vehicle-controlled trial to ensure unbiased results. The primary focus is to determine how well the cream alleviates symptoms of atopic dermatitis while monitoring for any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 6 years and older with a diagnosis of mild to moderate atopic dermatitis.

Not a fit: Patients with severe atopic dermatitis or those with serious medical conditions that could interfere with the study may not benefit.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing atopic dermatitis symptoms.

How similar studies have performed: Previous studies have shown promise with similar topical treatments for atopic dermatitis, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female subjects aged ≥ 6 years at screening.
2. Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6\~17 years at screening.
3. Have stable disease for the past 4 weeks prior to screening.
4. Have mild or moderate AD at baseline.
5. Have BSA affected by AD of 3%-20% at baseline.
6. Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
7. Being in good health as judged by the Investigator.
8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.

Exclusion Criteria:

1. Subjects with 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.
2. Previous treatment with roflumilast cream.
3. Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
8. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
9. Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.

Where this trial is running

Wuhu, Anhui and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisRoflumilast creamAtopic dermatitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.