Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-06 @ 1:52 PM
Study NCT ID:
NCT03599193
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2018-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Bioavailability Study of DFD-03 Compared to Tazorac® in Patients With Moderate Acne Vulgaris
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: