A Phase 3 interventional study of DFD-29 and Doxycycline in Papulopustular Rosacea, sponsored by Journey Medical Corporation. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Journey Medical Corporation · Phase 3, Interventional, and Treatment
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.
This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.
Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 2, 4, 8, 12, and 16. Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment modified scale without erythema (IGA), Clinician's Erythema Assessment (CEA), and total inflammatory lesion count at Weeks 2, 4, 8, 12, and 16 compared to Baseline.
Laboratory assessments of blood (hematology and biochemistry) and urine (routine tests) will be conducted at Screening and Week 16 (end of study [EOS] or early termination) to assess for any changes in the safety parameters. Other safety assessments include vital signs, physical examination, urine pregnancy tests (for females of childbearing potential), and collection of AE data.
The impact of the treatment on the quality of life (QoL) of the subjects will be assessed using the rosacea-specific tool RosaQoL in addition to the Dermatology Life Quality Index (DLQI) at Baseline and Weeks 2, 4, 8, 12, and 16.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 323 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Journey Medical Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DFD-29 (40 mg) extended release capsules
Drug: DFD-29
Doxycycline 40 mg modified release capsules
Drug: Doxycycline
Placebo capsules matching DFD-29
Drug: Placebo
DFD-29 (40 mg) extended release capsules
Doxycycline 40 mg capsules
Placebo capsules
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
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.
Time frame: Baseline to Week 16.
Change in Total Inflammatory Lesion Count Compared to Placebo.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Time frame: Baseline to Week 16.
IGA Treatment Success Compared to Doxycycline.
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Time frame: Baseline to Week 16.
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Time frame: Baseline to Week 16.
Clinician's Erythema Assessment (CEA) Compared to Placebo.
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.
Time frame: Baseline to Week 16.
| Milestone | DFD-29 | Doxycycline 40 mg Capsule | Placebo |
|---|---|---|---|
| Started | 122 | 121 | 80 |
| Completed | 117 | 98 | 73 |
| Not completed | 5 | 23 | 7 |
| Withdrew: Withdrawal by subject | 3 | 10 | 4 |
| Withdrew: Lost to follow-up | 2 | 7 | 1 |
| Withdrew: Adverse event | 0 | 4 | 2 |
| Withdrew: Protocol violation | 0 | 2 | 0 |
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.
| Participants | DFD-29 | Placebo |
|---|---|---|
| Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. | 79 | 25 |
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
| lesions | DFD-29 | Placebo |
|---|---|---|
| Change in Total Inflammatory Lesion Count Compared to Placebo. | -20.6 ± 0.77 | -11.4 ± 0.97 |
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
| Participants | DFD-29 | Doxycycline 40 mg |
|---|---|---|
| IGA Treatment Success Compared to Doxycycline. | 79 | 56 |
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
| lesions | DFD-29 | Doxycycline 40 mg |
|---|---|---|
| Change in Total Inflammatory Lesion Count Compared to Doxycycline. | -20.6 ± 0.69 | -15.6 ± 0.73 |
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.
| Participants | DFD-29 | Placebo |
|---|---|---|
| Clinician's Erythema Assessment (CEA) Compared to Placebo. | 39 | 11 |
Collected over From the signing of informed consent up to 16 weeks of study treatment.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DFD-29 | 0/121 (0%) | 0/121 (0%) | 17/121 (14%) |
| Doxycycline 40 mg | 0/116 (0%) | 0/116 (0%) | 19/116 (16.4%) |
| Placebo | 0/76 (0%) | 0/76 (0%) | 18/76 (23.7%) |
| Event | DFD-29 | Doxycycline 40 mg | Placebo |
|---|---|---|---|
| COVID-19Infections and infestations | 4/121 | 3/116 | 4/76 |
| NasopharyngitisInfections and infestations | 4/121 | 2/116 | 3/76 |
| DiarrheaGastrointestinal disorders | 2/121 | 2/116 | 3/76 |
| HeadacheNervous system disorders | 3/121 | 2/116 | 3/76 |
| NauseaGastrointestinal disorders | 0/121 | 4/116 | 2/76 |
| Dry SkinSkin and subcutaneous tissue disorders | 1/121 | 0/116 | 2/76 |
| Vulvovaginal mycotic infectionsInfections and infestations | 2/121 | 2/116 | 0/76 |
| HypertensionVascular disorders | 1/121 | 2/116 | 1/76 |
| GoutMetabolism and nutrition disorders | 0/121 | 2/116 | 0/76 |
ITT Subjects
| Age, Continuous(years) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| Mean | 47.7 ± 13.16 | 46.7 ± 14.11 | 47.2 ± 14.09 | 47.2 ± 13.72 |
| Sex: Female, Male(Participants) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| Female | 94 | 90 | 63 | 247 |
| Male | 28 | 31 | 17 | 76 |
| Race (NIH/OMB)(Participants) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 2 |
| Asian | 6 | 5 | 6 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 0 | 4 |
| White | 113 | 111 | 71 | 295 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 1 | 5 |
| Region of Enrollment(participants) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| United States | 122 | 121 | 80 | 323 |
| Investigators Global Assessment (IGA) grade(Participants) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| Moderate | 101 | 110 | 68 | 279 |
| Severe | 21 | 11 | 12 | 44 |
| Total Inflammatory Lesion Count(Lesion count) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.4 ± 10.46 | 23.8 ± 8.75 | 25.9 ± 8.84 | 25.3 ± 9.50 |
| Clinician's Erythema Assessment (CEA) score(Participants) | DFD-29 | Doxycycline 40 mg Capsule | Placebo | Total |
|---|---|---|---|---|
| 0 = None | 0 | 0 | 0 | 0 |
| 1 = Mild | 3 | 2 | 2 | 7 |
| 2 = Moderate | 50 | 45 | 32 | 127 |
| 3 = Significant | 57 | 61 | 37 | 155 |
| 4 = Severe | 12 | 13 | 9 | 34 |
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Studies of the drug tested here: DFD-29
Journey Medical Corporation