Back to resultsA Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
DFD-29 Extended Release Capsules (40 mg)
DFD-29 Extended Release Capsules (20 mg)
Oraycea® (doxycycline) Capsules
Placebo Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
- Male and female subjects aged 18 years and above.
- Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.
- Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
- Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
- Subjects must have not more than 2 nodules.
- Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
- Females must have a negative urine pregnancy test at the screening and baseline visit.
- Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose.
- Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion Criteria:
- Females who are pregnant or nursing or planning to become pregnant during the study.
- Male whose female partner is planning to conceive a child.
- Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
- Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
- Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.
- Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
- Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
- Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
- History of drug or alcohol abuse in the last year.
Sites / Locations
- Site 13
- Site 07
- Site 14
- Site 09
- Site 05
- Site 15
- Site 03
- Site 08
- Site 11
- Site 06
- Site 10
- Site 01
- Site 04
- Site 02
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
DFD-29 Extended Release Capsules (40 mg)
DFD-29 Extended Release Capsules (20 mg)
Oraycea® (doxycycline) Capsules
Placebo Capsules
Arm Description
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Placebo Capsules once per day for 16 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03340961
First Posted
October 19, 2017
Last Updated
February 4, 2021
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT03340961
Brief Title
A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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 (40 mg)
DFD-29 Extended Release Capsules (20 mg)
Doxycycline Modified Release Hard Capsules (40 mg)
Placebo Capsules
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFD-29 Extended Release Capsules (40 mg)
Arm Type
Experimental
Arm Description
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
Arm Title
DFD-29 Extended Release Capsules (20 mg)
Arm Type
Experimental
Arm Description
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Arm Title
Oraycea® (doxycycline) Capsules
Arm Type
Experimental
Arm Description
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Arm Title
Placebo Capsules
Arm Type
Placebo Comparator
Arm Description
Placebo Capsules once per day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
DFD-29 Extended Release Capsules (40 mg)
Intervention Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
DFD-29 Extended Release Capsules (20 mg)
Intervention Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
Oraycea® (doxycycline) Capsules
Intervention Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
Placebo Capsules
Intervention Description
Oral Treatment
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe
Description
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.
Time Frame
16 weeks
Title
Total Inflammatory Lesion Count Reduction
Description
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.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16
Description
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.
Time Frame
Median change in the score from Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
Male and female subjects aged 18 years and above.
Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.
Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
Subjects must have not more than 2 nodules.
Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
Females must have a negative urine pregnancy test at the screening and baseline visit.
Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose.
Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).
Exclusion Criteria:
Females who are pregnant or nursing or planning to become pregnant during the study.
Male whose female partner is planning to conceive a child.
Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.
Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
History of drug or alcohol abuse in the last year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivas Sidgiddi, MD
Organizational Affiliation
Director-Clinical Development
Official's Role
Study Director
Facility Information:
Facility Name
Site 13
City
Bad Bentheim
Country
Germany
Facility Name
Site 07
City
Berlin
Country
Germany
Facility Name
Site 14
City
Berlin
Country
Germany
Facility Name
Site 09
City
Bochum
Country
Germany
Facility Name
Site 05
City
Buxtehude
Country
Germany
Facility Name
Site 15
City
Darmstadt
Country
Germany
Facility Name
Site 03
City
Dülmen
Country
Germany
Facility Name
Site 08
City
Leipzig
Country
Germany
Facility Name
Site 11
City
Mahlow
Country
Germany
Facility Name
Site 06
City
Münster
Country
Germany
Facility Name
Site 10
City
Osnabrück
Country
Germany
Facility Name
Site 01
City
Pommelsbrunn
Country
Germany
Facility Name
Site 04
City
Potsdam
Country
Germany
Facility Name
Site 02
City
Wuppertal
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35096250
Citation
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.
Results Reference
derived
Learn more about this trial
A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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