A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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
1 other identifier
interventional
205
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 19, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedResults Posted
Study results publicly available
April 21, 2020
CompletedMarch 1, 2021
February 1, 2021
1.1 years
October 19, 2017
March 24, 2020
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16
Median change in the score from Baseline to Week 16
Study Arms (4)
DFD-29 Extended Release Capsules (40 mg)
EXPERIMENTALDFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
DFD-29 Extended Release Capsules (20 mg)
EXPERIMENTALDFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Oraycea® (doxycycline) Capsules
EXPERIMENTALOraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Placebo Capsules
PLACEBO COMPARATORPlacebo Capsules once per day for 16 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Site 13
Bad Bentheim, Germany
Site 07
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
Related Publications (1)
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.
PMID: 35096250DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Srinivas Sidgiddi, Senior Director
- Organization
- Dr. Reddy's Lab, INC
Study Officials
- STUDY DIRECTOR
Srinivas Sidgiddi, MD
Director-Clinical Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks: 1. DFD-29 Extended Release Capsules (40 mg) 2. DFD-29 Extended Release Capsules (20 mg) 3. Doxycycline Modified Release Hard Capsules (40 mg) 4. Placebo Capsules
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2017
First Posted
November 14, 2017
Study Start
October 1, 2017
Primary Completion
November 7, 2018
Study Completion
March 31, 2019
Last Updated
March 1, 2021
Results First Posted
April 21, 2020
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share