Trial intelligence / Profile preview

Botox in Erythematotelangiectatic Rosacea

NCT06331533Phase 4

Key facts

Status
Completed
Start
Nov 2022
Primary completion
May 2023
Countries
1
Sponsor
Istanbul Education Research Hospital
Modality
Recombinant Proteins and Enzymes
Conditions
rosacea
01

Overview

Phase 4, randomised, double-blind trial in rosacea comparing Botulinum toxin A with Placebo (2 arms). Primary endpoints: Clinician's Erythema Assessment at 1 month, Erythema Index at 1 month and 3 more. Started Nov 2022; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Botulinum toxin A

  • Placebo

03

Who it enrols

Adults aged 18-60 with erythematotelangiectatic rosacea, excluding those with recent medication use, prior Botox injections, or history of neuromuscular/autoimmune diseases.

04

Endpoints

Primary

  • Clinician's Erythema Assessment

  • Erythema Index

  • Melanin Index

  • Dermatoscopic Erythema Analysis

  • Patient Self-Assessment

Secondary

  • Vascular Structure Analysis

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