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A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)

NCT ID: NCT05343455

Last Updated: 2024-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2023-06-30

Brief Summary

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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. Of the 320 subjects, approximately 160 subjects are planned to be enrolled at 15 sites in the US, while the remaining subjects are to be enrolled at 14 sites in the EU.

Detailed Description

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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.

Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multinational, multicenter, randomized, parallel-group, double-blind, controlled study.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DFD-29

DFD-29 (40 mg) extended release capsules

Group Type EXPERIMENTAL

DFD-29

Intervention Type DRUG

DFD-29 (40 mg) extended release capsules

Doxycycline 40 mg

Doxycycline 40 mg modified release capsules

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

Doxycycline 40 mg capsules

Placebo

Placebo capsules matching DFD-29

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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DFD-29

DFD-29 (40 mg) extended release capsules

Intervention Type DRUG

Doxycycline

Doxycycline 40 mg capsules

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role collaborator

Journey Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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 15

Santa Monica, California, United States

Site Status

Clinical Trial Site 01

Doral, Florida, United States

Site Status

Clinical Trial Site 02

Miami, Florida, United States

Site Status

Clinical Trial Site 14

Miami, Florida, United States

Site Status

Clinical Trial Site 05

Miramar, Florida, United States

Site Status

Clinical Trial Site 08

Clarksville, Indiana, United States

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Clinical Trial Site 16

Plainfield, Indiana, United States

Site Status

Clinical Trial Site 10

Louisville, Kentucky, United States

Site Status

Clinical Trial Site 11

Saint Joseph, Missouri, United States

Site Status

Clinical Trial Site 09

Cincinnati, Ohio, United States

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Clinical Trial Site 04

Dublin, Ohio, United States

Site Status

Clinical Trial Site 06

Anderson, South Carolina, United States

Site Status

Clinical Trial Site 12

Austin, Texas, United States

Site Status

Clinical Trial Site 03

Houston, Texas, United States

Site Status

Clinical Trial Site 07

Pflugerville, Texas, United States

Site Status

Clinical Trial Site 17

Bad Bentheim, , Germany

Site Status

Clinical Trial Site 24

Berlin, , Germany

Site Status

Clinical Trial Site 22

Bochum, , Germany

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Clinical Trial Site 20

Darmstadt, , Germany

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Clinical Trial Site 25

Dülmen, , Germany

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Clinical Trial Site 19

Hamburg, , Germany

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Clinical Trial Site 21

Langenau, , Germany

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Clinical Trial Site 23

Merzig, , Germany

Site Status

Clinical Trial Site 18

Wuppertal, , Germany

Site Status

Countries

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United States Germany

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.

Reference Type DERIVED
PMID: 40042869 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DFD-29-CD-005

Identifier Type: -

Identifier Source: org_study_id