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Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.
Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4).
After assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16.
Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | Experimental | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. |
|
| DFD-29 Extended Release Capsules (20 mg) | Experimental | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. |
|
| Oraycea® (doxycycline) Capsules | Experimental | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. |
|
| Placebo Capsules | Placebo Comparator | Placebo Capsules once per day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | Drug | Oral Treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe | Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16. | 16 weeks |
| Total Inflammatory Lesion Count Reduction | The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16 | The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Sidgiddi, MD | Director-Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 13 | Bad Bentheim | Germany | ||||
| Site 07 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35096250 | Derived | Tsianakas A, Pieber T, Baldwin H, Feichtner F, Alikunju S, Gautam A, Shenoy S, Singh P, Sidgiddi S. Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial. J Clin Aesthet Dermatol. 2021 Dec;14(12):16-23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DFD-29 Extended Release Capsules (40 mg) | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment |
| FG001 | DFD-29 Extended Release Capsules (20 mg) |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2018 | Mar 9, 2020 |
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A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
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Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:
| DFD-29 Extended Release Capsules (20 mg) |
| Drug |
Oral Treatment |
|
| Oraycea® (doxycycline) Capsules | Drug | Oral Treatment |
|
| Placebo Capsules | Drug | Oral Treatment |
|
| Median change in the score from Baseline to Week 16 |
| Berlin |
| Germany |
| Site 14 | Berlin | Germany |
| Site 09 | Bochum | Germany |
| Site 05 | Buxtehude | Germany |
| Site 15 | Darmstadt | Germany |
| Site 03 | Dülmen | Germany |
| Site 08 | Leipzig | Germany |
| Site 11 | Mahlow | Germany |
| Site 06 | Münster | Germany |
| Site 10 | Osnabrück | Germany |
| Site 01 | Pommelsbrunn | Germany |
| Site 04 | Potsdam | Germany |
| Site 02 | Wuppertal | Germany |
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment |
| FG002 | Oraycea® (Doxycycline) Capsules | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment |
| FG003 | Placebo Capsules | Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The FAS (full analysis set) had all subjects who had at least one post Baseline efficacy assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | DFD-29 Extended Release Capsules (40 mg) | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment |
| BG001 | DFD-29 Extended Release Capsules (20 mg) | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment |
| BG002 | Oraycea® (Doxycycline) Capsules | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment |
| BG003 | Placebo Capsules | Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| 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 |
| ||||||||||||||||
| Total Inflammatory Lesion Count | Mean | Standard Deviation | Number of lesions |
|
| 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 Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe | Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16. | The FAS (full analysis set) included all subjects that had at least one post Baseline efficacy assessment. | Posted | Count of Participants | Participants | 16 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Total Inflammatory Lesion Count Reduction | The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants. | FAS population | Posted | Mean | Standard Deviation | Count of lesions | 16 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16 | The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16. | FAS Population | Posted | Median | Full Range | score on a scale | Median change in the score from Baseline to Week 16 |
|
AEs were collected from subjects from the time of signing of the ICF up to Week 16/End of Study Visit.
Adverse events were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed question of subjects, and by observation. All AEs from the time of signing of the ICF up to the EOS visit were recorded.
AEs occurring from the time of first study drug administration up to the End-of-Study were defined as treatment emergent AEs.
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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 Extended Release Capsules (40 mg) | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (40 mg): Oral Treatment | 0 | 52 | 1 | 52 | 37 | 52 |
| EG001 | DFD-29 Extended Release Capsules (20 mg) | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. DFD-29 Extended Release Capsules (20 mg): Oral Treatment | 0 | 48 | 2 | 48 | 33 | 48 |
| EG002 | Oraycea® (Doxycycline) Capsules | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. Oraycea® (doxycycline) Capsules: Oral Treatment | 0 | 48 | 2 | 48 | 27 | 48 |
| EG003 | Placebo Capsules | Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment | 0 | 53 | 0 | 53 | 35 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (18.0) | Systematic Assessment | Coronary artery disease |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment | Atrial fibrillation |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment | Lymphoma |
|
| Papilloma | Nervous system disorders | MedDRA (18.0) | Systematic Assessment | Papilloma |
|
| Retinal detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment | Retinal detachment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srinivas Sidgiddi, Senior Director | Dr. Reddy's Lab, INC | 908-458-5362 | Srinivassidgiddi@drreddys.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 2, 2018 | Mar 9, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Placebo Capsules once per day for 16 weeks.
Placebo Capsules: Oral Treatment
|
|
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Oraycea® (doxycycline) Capsules: Oral Treatment
| OG003 | Placebo Capsules | Placebo Capsules once per day for 16 weeks. Placebo Capsules: Oral Treatment |
|
|