Trial · NCT05608343
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
NCT05608343, Phase 3, Completed, Acrotech Biopharma Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD). Trials, record NCT05608343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05608343
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)
- NCT number
- NCT05608343
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 153 participants, actual
- Lead sponsor
- Acrotech Biopharma Inc.
- Conditions
- Atopic Dermatitis
- Interventions
- Difamilast, Placebo
- First posted
- 2022-11-08
- Last updated
- 2024-08-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD | Baseline, Day 29 | The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29 |
| Secondary | To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD | Baseline, Day 15, Day 22 and Day 29 | The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 |
Source ClinicalTrials.gov
Outcomes0
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/NCT05608343
GET https://conductscience.org/api/trials/v1/NCT05608343/registered