Clinical trial NCT05296629: A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Lead sponsor: Journey Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Dr. Reddy's Laboratories Limited
First posted: 2022-03-25
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, randomized, parallel-group, double-blind, controlled study.
Primary purpose: TREATMENT

Brief summary: This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

Detailed description: This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

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.

Eligibility criteria: Key Inclusion Criteria:

* Male and female subjects aged 18 years and above.
* 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.

Key Exclusion Criteria:

* Female subjects who are pregnant or nursing or planning to become pregnant during the study.
* 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
timeFrame: Baseline to Week 16.
measure: Change in Total Inflammatory Lesion Count Compared to Placebo.
timeFrame: Baseline to Week 16.
Secondary outcomes:
measure: IGA Treatment Success Compared to Doxycycline.
timeFrame: Baseline to Week 16.
measure: Change in Total Inflammatory Lesion Count Compared to Doxycycline.
timeFrame: Baseline to Week 16.
measure: Clinician's Erythema Assessment (CEA) Compared to Placebo.
timeFrame: Baseline to Week 16.
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Clinical Trial Site 05
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Trial Site 10
state: California
city: Fremont
country: United States
facility: Clinical Trial Site 03
state: California
city: San Diego
country: United States
facility: Clinical Trial Site 25
state: California
city: San Diego
country: United States
facility: Clinical Trial Site 29
state: California
city: Clearwater
country: United States
facility: Clinical Trial Site 11
state: Florida
city: Coral Gables
country: United States
facility: Clinical Trial Site 08
state: Florida
city: Coral Gables
country: United States
facility: Clinical Trial Site 22
state: Florida
city: Indianapolis
country: United States
facility: Clinical Trial Site 02
state: Indiana
city: Overland Park
country: United States
facility: Clinical Trial Site 27
state: Kansas
city: Brighton
country: United States
facility: Clinical Trial Site 09
state: Massachusetts
city: Ann Arbor
country: United States
facility: Clinical Trial Site 18
state: Michigan
city: Warren
country: United States
facility: Clinical Trial Site 28
state: Michigan
city: New Brighton
country: United States
facility: Clinical Trial Site 21
state: Minnesota
city: Las Vegas
country: United States
facility: Clinical Trial Site 15
state: Nevada
city: New York
country: United States
facility: Clinical Trial Site 24
state: New York
city: High Point
country: United States
facility: Clinical Trial Site 17
state: North Carolina
city: Wilmington
country: United States
facility: Clinical Trial Site 04
state: North Carolina
city: Beachwood
country: United States
facility: Clinical Trial Site 06
state: Ohio
city: Sugarloaf
country: United States
facility: Clinical Trial Site 01
state: Pennsylvania
city: East Greenwich
country: United States
facility: Clinical Trial Site 19
state: Rhode Island
city: Nashville
country: United States
facility: Clinical Trial Site 23
state: Tennessee
city: College Station
country: United States
facility: Clinical Trial Site 20
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site 13
state: Texas
city: Plano
country: United States
facility: Clinical Trial Site 07
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site 26
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site 12
state: Texas
Study officials:
affiliation: Journey Medical Corporation
name: Srinivas R Sidgiddi, M.D.
role: STUDY_DIRECTOR
References: