Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03599193
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.
Study:
NCT03599193
Study Brief:
Protocol Section:
NCT03599193