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| Name | Class |
|---|---|
| Dr. Reddy's Laboratories Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD-29 | Experimental | DFD-29 (40 mg) extended release capsules |
|
| Doxycycline 40 mg | Active Comparator | Doxycycline 40 mg modified release capsules |
|
| Placebo | Placebo Comparator | Placebo capsules matching DFD-29 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD-29 | Drug | DFD-29 (40 mg) extended release capsules |
| |
| Doxycycline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 16. |
| Change in Total Inflammatory Lesion Count Compared to Doxycycline. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas R Sidgiddi, M.D. | Journey Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site 05 | Rogers | Arkansas | 72758 | United States | ||
| Clinical Trial Site 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40042869 | Derived | Bhatia N, Del Rosso J, Stein Gold L, Lain E, Draelos ZD, Sidgiddi S; MVOR-1 and MVOR-2 Study Investigators. Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2025 May 1;161(5):499-507. doi: 10.1001/jamadermatol.2024.6542. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DFD-29 | DFD-29 (40 mg) extended release capsules DFD-29: DFD-29 (40 mg) extended release capsules |
| FG001 | Doxycycline 40 mg Capsule | Doxycycline 40 mg capsule administered once daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2022 | Sep 18, 2024 |
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A multicenter, randomized, parallel-group, double-blind, controlled study.
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| Drug |
Doxycycline 40 mg capsules |
|
| Placebo | Drug | Placebo capsules |
|
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg. |
| 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. | Baseline to Week 16. |
| Cerritos |
| California |
| 90703 |
| United States |
| Clinical Trial Site 03 | Fremont | California | 94538 | United States |
| Clinical Trial Site 25 | San Diego | California | 92123 | United States |
| Clinical Trial Site 29 | San Diego | California | 92123 | United States |
| Clinical Trial Site 11 | Clearwater | Florida | 33761 | United States |
| Clinical Trial Site 08 | Coral Gables | Florida | 33134 | United States |
| Clinical Trial Site 22 | Coral Gables | Florida | 33134 | United States |
| Clinical Trial Site 02 | Indianapolis | Indiana | 46250 | United States |
| Clinical Trial Site 27 | Overland Park | Kansas | 66210 | United States |
| Clinical Trial Site 09 | Brighton | Massachusetts | 02135 | United States |
| Clinical Trial Site 18 | Ann Arbor | Michigan | 48103 | United States |
| Clinical Trial Site 28 | Warren | Michigan | 48088 | United States |
| Clinical Trial Site 21 | New Brighton | Minnesota | 55112 | United States |
| Clinical Trial Site 15 | Las Vegas | Nevada | 89148 | United States |
| Clinical Trial Site 24 | New York | New York | 10019 | United States |
| Clinical Trial Site 17 | High Point | North Carolina | 27262 | United States |
| Clinical Trial Site 04 | Wilmington | North Carolina | 28405 | United States |
| Clinical Trial Site 06 | Beachwood | Ohio | 44122 | United States |
| Clinical Trial Site 01 | Sugarloaf | Pennsylvania | 18249 | United States |
| Clinical Trial Site 19 | East Greenwich | Rhode Island | 02818 | United States |
| Clinical Trial Site 23 | Nashville | Tennessee | 37215 | United States |
| Clinical Trial Site 20 | College Station | Texas | 77845 | United States |
| Clinical Trial Site 13 | Houston | Texas | 77055 | United States |
| Clinical Trial Site 07 | Plano | Texas | 75093 | United States |
| Clinical Trial Site 26 | San Antonio | Texas | 78213 | United States |
| Clinical Trial Site 12 | San Antonio | Texas | 78229 | United States |
| FG002 | Placebo | Placebo capsules matching DFD-29 Placebo: Placebo capsules |
| COMPLETED |
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| NOT COMPLETED |
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ITT Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | DFD-29 | DFD-29 (40 mg) extended release capsules DFD-29: DFD-29 (40 mg) extended release capsules |
| BG001 | Doxycycline 40 mg Capsule | Doxycycline 40 mg capsule administered once daily for 16 weeks |
| BG002 | Placebo | Placebo capsules matching DFD-29 Placebo: Placebo capsules |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Investigators Global Assessment (IGA) grade | 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. | Count of Participants | Participants |
| |||||||||||||||
| Total Inflammatory Lesion Count | Mean | Standard Deviation | Lesion count |
| |||||||||||||||
| Clinician's Erythema Assessment (CEA) score | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT population defined as, 'All randomized subjects' | Posted | Count of Participants | Participants | Baseline to Week 16. |
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| |||||||||||||||||||||||||||||
| Primary | 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. | ITT Population | Posted | Least Squares Mean | Standard Error | lesions | Baseline to Week 16. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | Baseline to Week 16. |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Least Squares Mean | Standard Error | lesions | Baseline to Week 16. |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Count of Participants | Participants | Baseline to Week 16. |
|
|
From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation.
The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DFD-29 | DFD-29 (40 mg) extended release capsules DFD-29: DFD-29 (40 mg) extended release capsules | 0 | 121 | 0 | 121 | 17 | 121 |
| EG001 | Doxycycline 40 mg | Doxycycline 40 mg modified release capsules Doxycycline: Doxycycline 40 mg capsules | 0 | 116 | 0 | 116 | 19 | 116 |
| EG002 | Placebo | Placebo capsules matching DFD-29 Placebo: Placebo capsules | 0 | 76 | 0 | 76 | 18 | 76 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infections | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srinivas Sidgiddi | Journey Medical Corporation | 9084585362 | ssidgiddi@jmcderm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 3, 2023 | Sep 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Severe |
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| 1 = Mild |
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| 2 = Moderate |
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| 3 = Significant |
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| 4 = Severe |
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