NCT02828241

A Study to Assess the Efficacy, Safety and Tolerability of DFD-04

A Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of DFD-04 (Itraconazole) Ointment, 5% in Patients With Inflammatory Lesions of Rosacea Over 12 Weeks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.

Detailed description

Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment \[IGA\] grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle ointment in a ratio of 2:1. During the 12-week treatment period subjects used the IMP twice daily with approximately 12 hours between applications. Subjects were instructed to treat affected skin in a defined treatment area on the face. The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8 and 12 (End of Treatment \[EoT\], defined as complete clearance of inflammatory lesions or Week 12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12. Safety assessments included investigator's assessment of application site reactions at Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas. Other safety assessments included vital signs (blood pressure \[BP\] and pulse rate) and urine pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine), extent of exposure, and Adverse Events. In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn from the first 12 subjects at various pre-specified timepoints.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	DFD-04 Ointment
OTHER	Placebo Ointment

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-11-01
• First posted: 2016-07-11
• Last updated: 2019-01-23
• Results posted: 2019-01-23

Locations

8 sites across 1 country: Germany