A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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|ClinicalTrials.gov Identifier: NCT03340961|
Recruitment Status : Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rosacea||Drug: DFD-29 Extended Release Capsules (40 mg) Drug: DFD-29 Extended Release Capsules (20 mg) Drug: Oraycea® (doxycycline) Capsules Drug: Placebo Capsules||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:
|Official Title:||A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: DFD-29 Extended Release Capsules (40 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (40 mg)
Experimental: DFD-29 Extended Release Capsules (20 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (20 mg)
Experimental: Oraycea® (doxycycline) Capsules
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Drug: Oraycea® (doxycycline) Capsules
Placebo Comparator: Placebo Capsules
Placebo Capsules once per day for 16 weeks.
Drug: Placebo Capsules
- Investigator Global Assessment (IGA) 0=Clear, 1=Near clear, 2=Mild, 3=Moderate, 4=Severe [ Time Frame: 16 weeks ]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.
- Total Inflammatory Lesion Count Reduction [ Time Frame: 16 Weeks ]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.
- Median change in RosaQoL (Rosacea Quality of Life) score from Baseline to Week 16 [ Time Frame: 16 Weeks ]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 subjects will have to rate on a 5 grade scale (1 to 5) their perception of the impact that Rosacea has on various dimensions influencing their quality of life. Higher the score poorer is the quality of life.
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): NCT03340961
|Bad Bentheim, Germany|
|Study Director:||Srinivas Sidgiddi, MD||Director-Clinical Development|