Clinical trial NCT03340961: A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multi-Center, Randomized, Double-Blind, Parallel-Group, Controlled Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe
timeFrame: 16 weeks
measure: Total Inflammatory Lesion Count Reduction
timeFrame: 16 Weeks
Secondary outcomes:
measure: Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16
timeFrame: Median change in the score from Baseline to Week 16
Other outcomes:
Locations:
city: Bad Bentheim
country: Germany
facility: Site 13
city: Berlin
country: Germany
facility: Site 07
city: Berlin
country: Germany
facility: Site 14
city: Bochum
country: Germany
facility: Site 09
city: Buxtehude
country: Germany
facility: Site 05
city: Darmstadt
country: Germany
facility: Site 15
city: Dülmen
country: Germany
facility: Site 03
city: Leipzig
country: Germany
facility: Site 08
city: Mahlow
country: Germany
facility: Site 11
city: Münster
country: Germany
facility: Site 06
city: Osnabrück
country: Germany
facility: Site 10
city: Pommelsbrunn
country: Germany
facility: Site 01
city: Potsdam
country: Germany
facility: Site 04
city: Wuppertal
country: Germany
facility: Site 02
Study officials:
affiliation: Director-Clinical Development
name: Srinivas Sidgiddi, MD
role: STUDY_DIRECTOR
References:
citation: 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.