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

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ClinicalTrials.gov Identifier: NCT03340961
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: DFD-29 Extended Release Capsules (40 mg) Drug: DFD-29 Extended Release Capsules (20 mg) Drug: Oraycea® (doxycycline) Capsules Drug: Placebo Capsules Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Each subject will be allocated to one of the following treatment groups, receiving 1 capsule once daily in the morning for 16 weeks:

  1. DFD-29 Extended Release Capsules (40 mg)
  2. DFD-29 Extended Release Capsules (20 mg)
  3. Doxycycline Modified Release Hard Capsules (40 mg)
  4. Placebo Capsules
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: DFD-29 Extended Release Capsules (40 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (40 mg)
Oral Treatment

Experimental: DFD-29 Extended Release Capsules (20 mg)
DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.
Drug: DFD-29 Extended Release Capsules (20 mg)
Oral Treatment

Experimental: Oraycea® (doxycycline) Capsules
Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.
Drug: Oraycea® (doxycycline) Capsules
Oral Treatment

Placebo Comparator: Placebo Capsules
Placebo Capsules once per day for 16 weeks.
Drug: Placebo Capsules
Oral Treatment




Primary Outcome Measures :
  1. Investigator Global Assessment (IGA) 0=Clear, 1=Near clear, 2=Mild, 3=Moderate, 4=Severe [ Time Frame: 16 weeks ]
    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.

  2. Total Inflammatory Lesion Count Reduction [ Time Frame: 16 Weeks ]
    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.


Secondary Outcome Measures :
  1. Median change in RosaQoL (Rosacea Quality of Life) score from Baseline to Week 16 [ Time Frame: 16 Weeks ]
    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 subjects will have to rate on a 5 grade scale (1 to 5) their perception of the impact that Rosacea has on various dimensions influencing their quality of life. Higher the score poorer is the quality of life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent.
  2. Male and female subjects aged 18 years and above.
  3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health as determined by the Investigator.
  4. Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.
  5. Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and pustules) of rosacea over the face.
  6. Subjects must have not more than 2 nodules.
  7. Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA scale.
  8. Females must have a negative urine pregnancy test at the screening and baseline visit.
  9. 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.
  10. 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).

Exclusion Criteria:

  1. Females who are pregnant or nursing or planning to become pregnant during the study.
  2. Male whose female partner is planning to conceive a child.
  3. Subjects who have been treated for rosacea within the 30 days prior to the Baseline Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).
  4. Subjects who have been treated with systemic retinoids within 6 months prior to the Baseline visit.
  5. Subjects who have participated in a trial involving any investigational product in the 90 days prior to the Baseline Visit.
  6. Subjects with any disease or medical condition that would interfere with the study outcome or place the subject at undue risk.
  7. Subjects who use or have used systemic steroids within the 30 days prior to the Baseline Visit or any other immunosuppressive medication.
  8. Subjects who are on anti-coagulants or those who are likely to require anti-coagulants during the study period.
  9. History of drug or alcohol abuse in the last year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340961


Contacts
Contact: Carmela Fritz 609-375-9929 cfritz@promiuspharma.com

Locations
Germany
Site 13 Recruiting
Bad Bentheim, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 07 Recruiting
Berlin, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 14 Recruiting
Berlin, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 09 Recruiting
Bochum, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 05 Recruiting
Buxtehude, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 15 Recruiting
Darmstadt, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 03 Recruiting
Dülmen, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 08 Recruiting
Leipzig, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 11 Recruiting
Mahlow, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 06 Recruiting
Münster, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 10 Recruiting
Osnabrück, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 01 Recruiting
Pommelsbrunn, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 04 Recruiting
Potsdam, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Site 02 Recruiting
Wuppertal, Germany
Contact: Carmela Fritz       cfritz@promiuspharma.com   
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Study Director: Sagar Munjal, MD VP and Head, Clinical Development

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03340961     History of Changes
Other Study ID Numbers: DFD-29-CD-002
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents