Trial · NCT06648772
Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study
NCT06648772, Phase 3, Completed, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study. Trials, record NCT06648772. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06648772
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study
- NCT number
- NCT06648772
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 190 participants, actual
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Conditions
- Plaque Psoriasis
- Interventions
- Roflumilast Cream 0.3%, Vehicle cream
- First posted
- 2024-10-18
- Last updated
- 2026-07-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects achieving IGA treatment success after 8 weeks of treatment | Baseline, week 8 | The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability. Treatment success is defined as an IGA score of 0 or 1 with an improvement of ≥ 2 points from baseline. |
| Secondary | Proportion of subjects achieving PASI-75 after 8 weeks of treatment. | Baseline, Week 8 | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-75 are those who achieve a 75% reduction in PASI from baseline. |
| Secondary | Proportion of subjects achieving PASI-90 after 8 weeks of treatment. | Baseline, Week 8 | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Subjects achieving PASI-90 are those who achieve a 90% reduction in PASI from baseline. |
| Secondary | Time required to achieve PASI-50 from baseline. | Until week 8 | Time required to achieve PASI-50 (i.e., PASI reduction ≥ 50% from baseline) from baseline. |
| Secondary | Proportion of subjects achieving IGA treatment success after 4 weeks of treatment. | Baseline, Week 4 | The IGA is a static evaluation of qualitative overall psoriasis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes inter-observer variability. Treatment success is defined as an IGA score of 0 or 1 with an improvement of ≥ 2 points from baseline. |
| Secondary | Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of 0 or 1 and an improvement of ≥ 2 points from baseline after 8 weeks of treatment | Baseline, Week 8 | I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded. |
| Secondary | Proportion of subjects with an I-IGA score ≥ 2 points at baseline achieving an I-IGA score of "0" after 8 weeks of treatment | Baseline, Week 8 | I-IGA means Intertriginous area IGA. For subjects with intertriginous area involvement of at least 'mild' severity by IGA (I-IGA≥2) at Baseline (using the IGA scale but evaluating intertriginous areas ONLY and NOT whole body involvement), an I-IGA will be recorded. |
| Secondary | Proportion of subjects with WI-NRS of ≥ 4 at baseline and a decrease in WI-NRS of ≥ 4 from baseline after 2, 4, and 8 weeks of treatment | Week 2, 4, 8 | WI-NRS (Worst Itch Numerical Rating Scale) assessments will be performed for subjects 12 years and older. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch"). |
| Secondary | Changes from baseline in the score of DLQI (aged ≥ 17 years)/CDLQI (aged 6-16 years) after 4 and 8 weeks of treatment | Week 4, 8 | Dermatology Life Quality Index (DLQI) and Children's Dermatology Life Quality Index (CDLQI) will be performed to measure how much skin problem has affected subjects' life over the last week. |
| Secondary | Changes from baseline in the total score of PSD (for adult subjects only) after 4 and 8 weeks of treatment | From baseline to Week 4 and 8 | Psoriasis Symptom Diary (PSD) will be used to assess the improvement in psoriasis symptom. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06648772
GET https://conductscience.org/api/trials/v1/NCT06648772/registered