Description Module

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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: 2025-12-24 @ 4:15 PM
Ignite Modification Date: 2025-12-24 @ 4:15 PM
NCT ID: NCT03590366
Brief Summary: This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
Detailed Description: This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea. At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR). The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit. Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12). Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA). Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study. Investigators plan to enroll approximately 130 subjects. Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
Study: NCT03590366
Study Brief:
Protocol Section: NCT03590366