Papulopustular RosaceaPhase 3MVOR-2NCT05343455
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
A Phase 3 study testing DFD-29 and Doxycycline in people with Papulopustular Rosacea, run by Journey Medical Corporation at 24 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- DFD-29 and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 29 Mar 2022to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States15 sites
Clinical Trial Site 06
Anderson, South Carolina, 29621
Clinical Trial Site 12
Austin, Texas, 78759
Clinical Trial Site 09
Cincinnati, Ohio, 45246
Clinical Trial Site 08
Clarksville, Indiana, 47129
Clinical Trial Site 01
Doral, Florida, 33178
Clinical Trial Site 04
Dublin, Ohio, 43016
Clinical Trial Site 03
Houston, Texas, 77056
Clinical Trial Site 10
Louisville, Kentucky, 40241
Clinical Trial Site 02
Miami, Florida, 33173
Clinical Trial Site 14
Miami, Florida, 33175
Clinical Trial Site 05
Miramar, Florida, 33027
Clinical Trial Site 07
Pflugerville, Texas, 78660
Clinical Trial Site 16
Plainfield, Indiana, 46168
Clinical Trial Site 11
Saint Joseph, Missouri, 64506
Clinical Trial Site 15
Santa Monica, California, 90404
Germany9 sites
Clinical Trial Site 17
Bad Bentheim, 48455
Clinical Trial Site 24
Berlin, 10247
Clinical Trial Site 22
Bochum, 44793
Clinical Trial Site 20
Darmstadt, 64283
Clinical Trial Site 25
Dülmen, 48249
Clinical Trial Site 19
Hamburg, 22391
Clinical Trial Site 21
Langenau, 89129
Clinical Trial Site 23
Merzig, 66663
Clinical Trial Site 18
Wuppertal, 42287
About this study
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
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.
Read the 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.
- Conditions
- Papulopustular Rosacea
- Being tested
- DFD-29, Doxycycline, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-29Drug
DFD-29 (40 mg) extended release capsules
DoxycyclineDrug
Doxycycline 40 mg capsules
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| DFD-29 | Experimental | DFD-29 (40 mg) extended release capsules Receives: Drug: DFD-29 |
| Doxycycline 40 mg | Active comparator | Doxycycline 40 mg modified release capsules Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Placebo capsules matching DFD-29 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo.
The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Measured: Baseline to Week 16
Change in Total Inflammatory Lesion Count Compared to Placebo.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Measured: Baseline to Week 16.
Secondary outcomes (3)
IGA Treatment Success Compared to Doxycycline.
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
The IGA is a 5-point scale ranging from '0'-Clear to '4' Severe, in which lower scores indicate a better outcome.
Measured: Baseline to Week 16.
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Measured: Baseline to Week 16.
Clinician's Erythema Assessment (CEA) Change Compared to Placebo.
Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
The CEA is a 5-point scale ranging from '0' - No Redness to '4' - Fiery Redness, in which lower scores indicate a better outcome.
Measured: Baseline to Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start29 Mar 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multinational, multicenter, randomized, parallel-group, double-blind, controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
- Investigators
- Srinivas R Sidgiddi, M.D., Study director, Journey Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343455
- Sponsor's protocol ID
- DFD-29-CD-005
- Acronym
- MVOR-2
- Status last verified
- Nov 2024
- First submitted
- 18 Apr 2022
- Last updated
- 3 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40042869
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05343455
- Acronym / sponsor ID
- MVOR-2 / DFD-29-CD-005
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A multinational, multicenter, randomized, parallel-group, double-blind, controlled study.
| Arm | Type | Receives |
|---|---|---|
| DFD-29 | Experimental | Drug: DFD-29DFD-29 (40 mg) extended release capsules |
| Doxycycline 40 mg | Active comparator | Drug: DoxycyclineDoxycycline 40 mg modified release capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules matching DFD-29 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFD-29DFD-29 (40 mg) extended release capsules | Drug | DFD-29 |
| DoxycyclineDoxycycline 40 mg capsules | Drug | Doxycycline 40 mg |
| PlaceboPlacebo capsules | Drug | Placebo |
Primary outcome
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
Time frame: Baseline to Week 16
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Change in Total Inflammatory Lesion Count Compared to Placebo.
Time frame: Baseline to Week 16.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
3 secondary outcomes
IGA Treatment Success Compared to Doxycycline.
Time frame: Baseline to Week 16.
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
Time frame: Baseline to Week 16.
Clinician's Erythema Assessment (CEA) Change Compared to Placebo.
Time frame: Baseline to Week 16.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40042869Bhatia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas R Sidgiddi, M.D. study director
Journey Medical Corporation
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DFD-29 and Doxycycline in people with Papulopustular Rosacea, run by Journey Medical Corporation at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo. (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.