A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
NCT ID: NCT05296629
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2022-03-14
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DFD-29
DFD-29 (40 mg) extended release capsules
DFD-29
DFD-29 (40 mg) extended release capsules
Doxycycline 40 mg
Doxycycline 40 mg modified release capsules
Doxycycline
Doxycycline 40 mg capsules
Placebo
Placebo capsules matching DFD-29
Placebo
Placebo capsules
Interventions
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DFD-29
DFD-29 (40 mg) extended release capsules
Doxycycline
Doxycycline 40 mg capsules
Placebo
Placebo capsules
Eligibility Criteria
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Inclusion Criteria
* Subjects must be in good general health as determined by the investigator and supported by the medical history.
* Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade 4 (severe) at Baseline.
* Subjects must have 15 to 60 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face at Baseline.
* Subjects must have not more than 2 nodules or cysts at Baseline.
Exclusion Criteria
* Male subjects whose female partner is planning to conceive a child.
* Clinically significant abnormal laboratory test results that, in the opinion of the investigator, would compromise the subject's safety or ability to participate in the trial.
* History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
* History of lupus-like syndrome, autoimmune hepatitis, vasculitis, or serum sickness.
* Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
18 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Journey Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Srinivas R Sidgiddi, M.D.
Role: STUDY_DIRECTOR
Journey Medical Corporation
Locations
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Clinical Trial Site 05
Rogers, Arkansas, United States
Clinical Trial Site 10
Cerritos, California, United States
Clinical Trial Site 03
Fremont, California, United States
Clinical Trial Site 25
San Diego, California, United States
Clinical Trial Site 29
San Diego, California, United States
Clinical Trial Site 11
Clearwater, Florida, United States
Clinical Trial Site 08
Coral Gables, Florida, United States
Clinical Trial Site 22
Coral Gables, Florida, United States
Clinical Trial Site 02
Indianapolis, Indiana, United States
Clinical Trial Site 27
Overland Park, Kansas, United States
Clinical Trial Site 09
Brighton, Massachusetts, United States
Clinical Trial Site 18
Ann Arbor, Michigan, United States
Clinical Trial Site 28
Warren, Michigan, United States
Clinical Trial Site 21
New Brighton, Minnesota, United States
Clinical Trial Site 15
Las Vegas, Nevada, United States
Clinical Trial Site 24
New York, New York, United States
Clinical Trial Site 17
High Point, North Carolina, United States
Clinical Trial Site 04
Wilmington, North Carolina, United States
Clinical Trial Site 06
Beachwood, Ohio, United States
Clinical Trial Site 01
Sugarloaf, Pennsylvania, United States
Clinical Trial Site 19
East Greenwich, Rhode Island, United States
Clinical Trial Site 23
Nashville, Tennessee, United States
Clinical Trial Site 20
College Station, Texas, United States
Clinical Trial Site 13
Houston, Texas, United States
Clinical Trial Site 07
Plano, Texas, United States
Clinical Trial Site 26
San Antonio, Texas, United States
Clinical Trial Site 12
San Antonio, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DFD-29-CD-004
Identifier Type: -
Identifier Source: org_study_id