RosaceaPhase 2NCT02828241
A Study to Assess the Efficacy, Safety and Tolerability of DFD-04
A Phase 2 study testing DFD-04 Ointment in people with Rosacea, run by Dr. Reddy's Laboratories Limited at 8 sites in Germany.
Trial summary
The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rosacea
- What is being tested?
- DFD-04 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 8 sitesGermany
- Study dates
- Jul 2016to Nov 2017
- Phase
- Phase 2
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
- Subjects must be willing to provide authorization to use protected health information.
- Subjects, any gender or race, must be in good general health as determined by the Investigator
- Subjects must have a clinical diagnosis of papulopustular rosacea, Investigator's Global Assessment (IGA) grade 2 - 3.
- Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over the face.
- Subjects must have a Clinician's Erythema Assessment (CEA) score of 2 - 3.
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- Subjects must have no more than 2 nodules.
- Subjects must agree to only use the study products and to not use any other treatment for rosacea (prescription or over the counter) or any other skin care or cosmetics product (make-up etc.) on the facial skin of the treatment area during the course of the study.
- Subjects must be free of any systemic or dermatologic disorder, which in the opinion of the Investigator, will interfere with the study results.
- Females 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 reliable method of contraception with a failure rate of less than 1 percent per year when used consistently and correctly.
- Subject 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).
- Subject is physically able to apply study product to all affected areas.
Who cannot join
- Females who are pregnant or nursing or planning to become pregnant during the study.
- Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit.
- 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 30 days prior to the Baseline Visit.
- Subjects with any disease or medical condition that would interfere with the study or place the subject at undue risk especially cardiovascular diseases, reduced lung function (including asthma), renal dysfunction or liver dysfunction.
- Subjects who have been treated within 30 days prior to baseline visit with methadone,disopyramide, dofetilide, dronedarone, quinidine, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ranolazine, eplerenone, cisapride, lovastatin, simvastatin, ticagrelor, terfenadine, astemizole, mizolastine, eletriptan, as well as lovastatin, simvastatin and atorvastatin and, in subjects with varying degrees of renal or hepatic impairment, colchicine, fesoterodine, telithromycin and solifenacin.
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- Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
- Subjects positive for human immunodeficiency virus (HIV), hepatitis B and hepatitis C-test at screening.
- Subjects who are unable to comply with study requirements.
- Subjects with other skin diseases that may confound the evaluation of rosacea.
- History of organ transplant requiring immunosuppression, HIV, or other immune compromised state.
- Subject who in the opinion of the investigator or physician performing the initial examination the subject should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent
- Subject with close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial sites or subject who are an employee of sponsor.
- Subject institutionalized because of legal or regulatory order.
- History of drug or alcohol abuse in the last year.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Site 201
Berlin, 10117
Site 208
Berlin, 10783
Site 202
Bochum, 44803
Site 205
Hamburg, 22391
Site 203
Mahlow, 15831
Site 204
Münster, 48179
Site 207
Potsdam, 14467
Site 206
Wiesbaden, 65199
About this study
Official title: A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in Patients With Inflammatory Lesions of Rosacea Over 12 Weeks
The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.
Read the detailed description
Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment [IGA] grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle ointment in a ratio of 2:1.
During the 12-week treatment period subjects used the IMP twice daily with approximately 12 hours between applications. Subjects were instructed to treat affected skin in a defined treatment area on the face.
The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8 and 12 (End of Treatment [EoT], defined as complete clearance of inflammatory lesions or Week 12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12.
Safety assessments included investigator's assessment of application site reactions at Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas.
Other safety assessments included vital signs (blood pressure [BP] and pulse rate) and urine pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine), extent of exposure, and Adverse Events.
In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn from the first 12 subjects at various pre-specified timepoints.
- Conditions
- Rosacea
- Being tested
- DFD-04 Ointment, Placebo Ointment
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-04 OintmentDrug
Placebo OintmentOther
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| DFD-04 Ointment | Experimental | DFD-04 (Itraconazole) Ointment Receives: Drug: DFD-04 Ointment |
| Placebo Ointment | Placebo comparator | Placebo Ointment Receives: Other: Placebo Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Lesion Counts
Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Measured: At the end of study (12 weeks)
Number of Subjects With Investigator's Global Assessment (IGA) Success
Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Measured: At the end of study (12 weeks)
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale
Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.
Measured: At end of study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017
- Study completionNov 2017
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.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srinivas R Sidgiddi, MD, Study director, Dr. Reddy's Laboratories Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828241
- Sponsor's protocol ID
- DFD04-CD-002
- Status last verified
- Jan 2019
- First submitted
- 7 Jul 2016
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in Patients With Inflammatory Lesions of Rosacea Over 12 Weeks
- ClinicalTrials.gov ID
- NCT02828241
- Acronym / sponsor ID
- DFD04-CD-002
- Conditions
- Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.
Detailed description
Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment [IGA] grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle ointment in a ratio of 2:1.
During the 12-week treatment period subjects used the IMP twice daily with approximately 12 hours between applications. Subjects were instructed to treat affected skin in a defined treatment area on the face.
The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8 and 12 (End of Treatment [EoT], defined as complete clearance of inflammatory lesions or Week 12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12.
Safety assessments included investigator's assessment of application site reactions at Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas.
Other safety assessments included vital signs (blood pressure [BP] and pulse rate) and urine pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine), extent of exposure, and Adverse Events.
In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn from the first 12 subjects at various pre-specified timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFD-04 Ointment | Experimental | Drug: DFD-04 OintmentDFD-04 (Itraconazole) Ointment |
| Placebo Ointment | Placebo comparator | Other: Placebo OintmentPlacebo Ointment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
- Subjects must be willing to provide authorization to use protected health information.
- Subjects, any gender or race, must be in good general health as determined by the Investigator
- Subjects must have a clinical diagnosis of papulopustular rosacea, Investigator's Global Assessment (IGA) grade 2 - 3.
- Subjects must have 6 - 30 inflammatory lesions (papules and pustules) of rosacea over the face.
Key exclusion criteria (15 listed)
- Females who are pregnant or nursing or planning to become pregnant during the study.
- Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit.
- 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 30 days prior to the Baseline Visit.
- Subjects with any disease or medical condition that would interfere with the study or place the subject at undue risk especially cardiovascular diseases, reduced lung function (including asthma), renal dysfunction or liver dysfunction.
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-04 Ointment | Drug | DFD-04 Ointment |
| Placebo OintmentAlso: Placebo | Other | Placebo Ointment |
Primary outcome
Change in Inflammatory Lesion Counts
Time frame: At the end of study (12 weeks)
Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.
Number of Subjects With Investigator's Global Assessment (IGA) Success
Time frame: At the end of study (12 weeks)
Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.
Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale
Time frame: At end of study (12 weeks)
Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MD study director
Dr. Reddy's Laboratories Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFD-04 Ointment in people with Rosacea, run by Dr. Reddy's Laboratories Limited at 8 sites in Germany.
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 13 inclusion and 15 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Jan 2019). 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?
Change in Inflammatory Lesion Counts (time frame: At the end of study (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.