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

Rosacea Clinical Trial

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340961
• Other study ID #: DFD-29-CD-002
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2021
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 31, 2019
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• DFD-29 Extended Release Capsules (40 mg)
Oral Treatment
• DFD-29 Extended Release Capsules (20 mg)
Oral Treatment
• Oraycea® (doxycycline) Capsules
Oral Treatment
• Placebo Capsules
Oral Treatment

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Primary	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.	16 Weeks
Secondary	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.	Median change in the score from Baseline to Week 16