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RosaceaPhase 2NCT03340961

A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules

A Phase 2 study testing DFD-29 Extended Release Capsules (40 mg), DFD-29 Extended Release Capsules (20 mg) and Oraycea® (doxycycline) Capsules in people with Rosacea, run by Dr. Reddy's Laboratories Limited at 14 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rosacea
What is being tested?
DFD-29 Extended Release Capsules (40 mg), DFD-29 Extended Release Capsules (20 mg) and Oraycea® (doxycycline) Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
14 sitesGermany
Study dates
1 Oct 2017to 31 Mar 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older 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.
  • Male and female subjects aged 18 years and above.
  • Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.
  • Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
  • Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
  • Subjects must have not more than 2 nodules.
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  • Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
  • Females must 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 highly effective method of contraception with a pearl index of <1% up to 1 month after last dose.
  • Subjects 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).

Who cannot join

  • Females who are pregnant or nursing or planning to become pregnant during the study.
  • Male whose female partner is planning to conceive a child.
  • Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
  • 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 90 days prior to the Baseline Visit.
  • Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
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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 who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
  • History of drug or alcohol abuse in the last year.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Site 13

    Bad Bentheim

  • Site 07

    Berlin

  • Site 14

    Berlin

  • Site 09

    Bochum

  • Site 05

    Buxtehude

  • Site 15

    Darmstadt

  • Site 03

    Dülmen

  • Site 08

    Leipzig

  • Site 11

    Mahlow

  • Site 06

    Münster

  • Site 10

    Osnabrück

  • Site 01

    Pommelsbrunn

  • Site 04

    Potsdam

  • Site 02

    Wuppertal

Other trials in Germany

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks

Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline.

Read the detailed description

Two hundred (200) male and female subjects with papulopustular rosacea will be enrolled to get 176 completed subjects (forty-four (44) completers each in groups 1 to 4).

After assessing eligibility during an up to 28 days screening period, 200 subjects will be enrolled in the study (fifty subjects each in groups 1 to 4). Subject visits are scheduled at Screening, Baseline (Day 1), and Weeks 4, 8, 12 and 16.

Clinical assessments of efficacy will be conducted based on Investigator's Global Assessment (IGA, modified scale without erythema), Clinician's Erythema Assessment (CEA), and on inflammatory lesion counts at Weeks 4, 8, 12 and 16 in comparison to Baseline. Additionally, high sensitivity C-reactive protein (hs-CRP) in the blood will be assessed at Baseline, and at Week 16 to explore any impact of the treatment on the inflammatory pathology.

Conditions
Rosacea
Being tested
DFD-29 Extended Release Capsules (40 mg), DFD-29 Extended Release Capsules (20 mg), Oraycea® (doxycycline) Capsules, Placebo Capsules
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DFD-29 Extended Release Capsules (40 mg)Drug

    Oral Treatment

  • DFD-29 Extended Release Capsules (20 mg)Drug

    Oral Treatment

  • Oraycea® (doxycycline) CapsulesDrug

    Oral Treatment

  • Placebo CapsulesDrug

    Oral Treatment

Study groups in NCT03340961
Study groupRoleWhat they receive
DFD-29 Extended Release Capsules (40 mg)ExperimentalDFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
Receives: Drug: DFD-29 Extended Release Capsules (40 mg)
DFD-29 Extended Release Capsules (20 mg)ExperimentalDFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Receives: Drug: DFD-29 Extended Release Capsules (20 mg)
Oraycea® (doxycycline) CapsulesExperimentalOraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Receives: Drug: Oraycea® (doxycycline) Capsules
Placebo CapsulesPlacebo comparatorPlacebo Capsules once per day for 16 weeks.
Receives: Drug: Placebo Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe

    Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.

    Measured: 16 weeks

  2. Total Inflammatory Lesion Count Reduction

    The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.

    Measured: 16 Weeks

Secondary outcomes (1)

  1. Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16

    The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.

    Measured: Median change in the score from 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.

  1. First posted14 Nov 2017
  2. Study start1 Oct 2017
  3. Primary completion7 Nov 2018
  4. Study completion31 Mar 2019

Resources

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
Model description
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03340961
Sponsor's protocol ID
DFD-29-CD-002
Status last verified
Feb 2021
First submitted
19 Oct 2017
Last updated
1 Mar 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsianakas A, Pieber T, Baldwin H, Feichtner F, Alikunju S, Gautam A, Shenoy S, Singh P, Sidgiddi S. Minocycline Extended-Release Comparison with Doxycycline for the Treatment of Rosacea: A Randomized, Head-to-Head, Clinical Trial. J Clin Aesthet Dermatol. 2021 Dec;14(12):16-23.

    PubMed 35096250

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DFD-29 Extended Release Capsules (40 mg), DFD-29 Extended Release Capsules (20 mg) and Oraycea® (doxycycline) Capsules in people with Rosacea, run by Dr. Reddy's Laboratories Limited at 14 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 10 inclusion and 9 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 21 Apr 2020). 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 Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe (time frame: 16 weeks). 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 NCT03340961, 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 1 Mar 2021.

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