Trial · NCT05296629
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
NCT05296629, Phase 3, Completed, Journey Medical Corporation; results first posted 2024-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. Trials, record NCT05296629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05296629
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
- NCT number
- NCT05296629
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- Journey Medical Corporation
- Conditions
- Papulopustular Rosacea
- Interventions
- DFD-29, Doxycycline, Placebo
- First posted
- 2022-03-25
- Last updated
- 2024-12-03
- Results first posted
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | Baseline to Week 16. | Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome. |
| Primary | Change in Total Inflammatory Lesion Count Compared to Placebo. | Baseline to Week 16. | Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo. |
| Secondary | IGA Treatment Success Compared to Doxycycline. | Baseline to Week 16. | Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. |
| Secondary | Change in Total Inflammatory Lesion Count Compared to Doxycycline. | Baseline to Week 16. | Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. |
| Secondary | Clinician's Erythema Assessment (CEA) Compared to Placebo. | Baseline to Week 16. | Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | Baseline to Week 16. | ITT population defined as, 'All randomized subjects' | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Total Inflammatory Lesion Count Compared to Placebo. | Baseline to Week 16. | ITT Population | lesions | LEAST_SQUARES_MEAN |
| SECONDARY | IGA Treatment Success Compared to Doxycycline. | Baseline to Week 16. | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Total Inflammatory Lesion Count Compared to Doxycycline. | Baseline to Week 16. | ITT Population | lesions | LEAST_SQUARES_MEAN |
| SECONDARY | Clinician's Erythema Assessment (CEA) Compared to Placebo. | Baseline to Week 16. | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | DFD-29 | 79 | Participants | ||
| Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | Placebo | 25 | Participants | ||
| Change in Total Inflammatory Lesion Count Compared to Placebo. | DFD-29 | -20.6 | Standard Error 0.77 | lesions | |
| Change in Total Inflammatory Lesion Count Compared to Placebo. | Placebo | -11.4 | Standard Error 0.97 | lesions | |
| IGA Treatment Success Compared to Doxycycline. | DFD-29 | 79 | Participants | ||
| IGA Treatment Success Compared to Doxycycline. | Doxycycline 40 mg | 56 | Participants | ||
| Change in Total Inflammatory Lesion Count Compared to Doxycycline. | DFD-29 | -20.6 | Standard Error 0.69 | lesions | |
| Change in Total Inflammatory Lesion Count Compared to Doxycycline. | Doxycycline 40 mg | -15.6 | Standard Error 0.73 | lesions | |
| Clinician's Erythema Assessment (CEA) Compared to Placebo. | DFD-29 | 39 | Participants | ||
| Clinician's Erythema Assessment (CEA) Compared to Placebo. | Placebo | 11 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DFD-29 | 122 | |
| Overall Study | STARTED | Doxycycline 40 mg Capsule | 121 | |
| Overall Study | STARTED | Placebo | 80 | |
| Overall Study | COMPLETED | DFD-29 | 117 | |
| Overall Study | COMPLETED | Doxycycline 40 mg Capsule | 98 | |
| Overall Study | COMPLETED | Placebo | 73 | |
| Overall Study | NOT COMPLETED | DFD-29 | 5 | |
| Overall Study | NOT COMPLETED | Doxycycline 40 mg Capsule | 23 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | DFD-29 | 4 | 121 | |
| other | COVID-19 | Infections and infestations | Doxycycline 40 mg | 3 | 116 | |
| other | COVID-19 | Infections and infestations | Placebo | 4 | 76 | |
| other | Nasopharyngitis | Infections and infestations | DFD-29 | 4 | 121 | |
| other | Nasopharyngitis | Infections and infestations | Doxycycline 40 mg | 2 | 116 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 76 | |
| other | Vulvovaginal mycotic infections | Infections and infestations | DFD-29 | 2 | 121 | |
| other | Vulvovaginal mycotic infections | Infections and infestations | Doxycycline 40 mg | 2 | 116 | |
| other | Vulvovaginal mycotic infections | Infections and infestations | Placebo | 0 | 76 | |
| other | Diarrhea | Gastrointestinal disorders | DFD-29 | 2 | 121 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DFD-29 | 0 | 121 |
| Total, all-cause mortality | Doxycycline 40 mg | 0 | 116 |
| Total, all-cause mortality | Placebo | 0 | 76 |
| Total, other adverse events | DFD-29 | 17 | 121 |
| Total, other adverse events | Doxycycline 40 mg | 19 | 116 |
| Total, other adverse events | Placebo | 18 | 76 |
| Total, serious adverse events | DFD-29 | 0 | 121 |
| Total, serious adverse events | Doxycycline 40 mg | 0 | 116 |
| Total, serious adverse events | Placebo | 0 | 76 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40042869 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DFD-29 vs Doxycycline 40 mg: IGA Treatment Success Compared to Doxycycline. | Trial comparisons |
| DFD-29 vs Placebo: Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | Trial comparisons |
| DFD-29 vs Placebo: Clinician's Erythema Assessment (CEA) Compared to Placebo. | Trial comparisons |
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/NCT05296629
GET https://conductscience.org/api/trials/v1/NCT05296629/events?page=2