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

NCT ID: NCT03340961

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DFD-29 Extended Release Capsules (40 mg)

DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks.

Group Type: EXPERIMENTAL

DFD-29 Extended Release Capsules (40 mg)

Intervention Type: DRUG

Oral Treatment

DFD-29 Extended Release Capsules (20 mg)

DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks.

Group Type: EXPERIMENTAL

DFD-29 Extended Release Capsules (20 mg)

Intervention Type: DRUG

Oral Treatment

Oraycea® (doxycycline) Capsules

Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks.

Group Type: EXPERIMENTAL

Oraycea® (doxycycline) Capsules

Intervention Type: DRUG

Oral Treatment

Placebo Capsules

Placebo Capsules once per day for 16 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Capsules

Intervention Type: DRUG

Oral Treatment

Interventions

DFD-29 Extended Release Capsules (40 mg)

Oral Treatment

Intervention Type: DRUG

DFD-29 Extended Release Capsules (20 mg)

Oral Treatment

Intervention Type: DRUG

Oraycea® (doxycycline) Capsules

Oral Treatment

Intervention Type: DRUG

Placebo Capsules

Oral Treatment

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivas Sidgiddi, MD

Role: STUDY_DIRECTOR

Director-Clinical Development

Locations

Site 13

Bad Bentheim, , Germany

Site 07

Berlin, , Germany

Site 14

Berlin, , Germany

Site 09

Bochum, , Germany

Site 05

Buxtehude, , Germany

Site 15

Darmstadt, , Germany

Site 03

Dülmen, , Germany

Site 08

Leipzig, , Germany

Site 11

Mahlow, , Germany

Site 06

Münster, , Germany

Site 10

Osnabrück, , Germany

Site 01

Pommelsbrunn, , Germany

Site 04

Potsdam, , Germany

Site 02

Wuppertal, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 35096250 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

DFD-29-CD-002

Identifier Type: -

Identifier Source: org_study_id