NCT03599193

A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris

A Randomized, Open-Label, Multiple Dose, Bioavailability Study of DFD-03 (Tazarotene Lotion, 0.1 % ) Dosed Twice Daily Compared to Once Daily Tazorac® (Tazarotene) Cream, 0.1% in Patients With Moderate Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 9 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris.

Detailed description

This was a multicenter, randomized, multiple-dose, laboratory-blinded, open-label, 2-arm, parallel-arm study in subjects with moderate acne vulgaris. Approximately 62 subjects were randomized, stratified by age (Adult subjects: 17 years or older; Pediatric subjects: 9 years to 16 years 11 months for the Test product and 12 years to 16 years 11 months for the Reference product). The study was conducted in two parts, Part A and Part B in a sequential manner. Based on full PK profiles generated for adult subjects in Part A, the sparse PK sampling design in pediatric population was established in Part B.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene Lotion, 0.1%	DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off
DRUG	Tazarotene Cream, 0.1%	Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours

Timeline

• Start date: 2017-10-04
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2018-07-26
• Last updated: 2021-03-01
• Results posted: 2020-09-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study