A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (MVOR-1)
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| ClinicalTrials.gov Identifier: NCT05296629 |
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Recruitment Status :
Completed
First Posted : March 25, 2022
Last Update Posted : August 2, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Papulopustular Rosacea | Drug: DFD-29 Drug: Doxycycline Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 323 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A multicenter, randomized, parallel-group, double-blind, controlled study. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks. |
| Actual Study Start Date : | March 14, 2022 |
| Actual Primary Completion Date : | June 30, 2023 |
| Actual Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: DFD-29
DFD-29 (40 mg) extended release capsules
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Drug: DFD-29
DFD-29 (40 mg) extended release capsules |
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Active Comparator: Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
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Drug: Doxycycline
Doxycycline 40 mg capsules |
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Placebo Comparator: Placebo
Placebo capsules matching DFD-29
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Drug: Placebo
Placebo capsules |
- Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. [ Time Frame: 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.
- Total Inflammatory Lesion Count Reduction Compared to Placebo. [ Time Frame: Baseline to Week 16. ]Total inflammatory lesion count (sum of papules, pustules, and nodules) reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo.
- Percentage Change in Total Inflammatory Lesion Count Compared to Placebo. [ Time Frame: Baseline to Week 16. ]Percentage Change in Total inflammatory lesion count (sum of papules, pustules, and nodules) from Baseline to Week 16, in the DFD-29 group compared to Placebo.
- IGA Treatment Success Compared to Doxycycline. [ Time Frame: 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.
- Total Inflammatory Lesion Count Reduction Compared to Doxycycline. [ Time Frame: Baseline to Week 16. ]Total inflammatory lesion count reduction from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
- Clinician's Erythema Assessment (CEA) Compared to Placebo. [ Time Frame: 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.
- Change in Dermatology Life Quality Index (DLQI) Score Compared to Placebo. [ Time Frame: Baseline to Week 16. ]Change in DLQI score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Male and female subjects aged 18 years and above.
- Subjects must be in good general health as determined by the investigator and supported by the medical history.
- Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
- Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
- Subjects must have not more than 2 nodules or cysts at Baseline.
Key Exclusion Criteria:
- Female subjects who are pregnant or nursing or planning to become pregnant during the study.
- Male subjects whose female partner is planning to conceive a child.
- Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
- History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
- Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05296629
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| Study Director: | Srinivas R Sidgiddi, M.D. | Journey Medical Corporation |
| Responsible Party: | Journey Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT05296629 |
| Other Study ID Numbers: |
DFD-29-CD-004 |
| First Posted: | March 25, 2022 Key Record Dates |
| Last Update Posted: | August 2, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Rosacea Skin Diseases Doxycycline Anti-Bacterial Agents |
Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |