NCT06331533

Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Effects of Botulinum Toxin Type a Treatment on Clinical and Biophysical Parameters in Patients With Erythematotelangiectatic Rosacea: A Prospective, Randomized, Placebo-controlled, Double-masked Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Istanbul Training and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy.

Detailed description

There is no gold standard treatment for erythematotelangiectatic rosacea (ETR). In recent years, some studies have been conducted to demonstrate the efficacy of intradermal botulinum toxin A (BoNT-A) treatment in ETR and facial erythema. Studies including objective and quantitative measurements are limited. This study aims to investigate the efficacy and safety of intradermal BoNT-A treatment in ETR patients. This randomised, double-blind, split-face study included 30 participants with erythematotelangiectatic rosacea (ETR). They were randomly randomised to intradermal BoNT-A on one side of the face and placebo on the other side. Clinician's erythema assessment (CEA) score, patient self-assessment (PSA) score, erythema index (EI), melanin index (MI), dermatoscopic and capillaroscopic analyses of background erythema and vascular structure were assessed at baseline and one month after treatment.

Conditions

• Erythematotelangiectatic Rosacea

Interventions

Type	Name	Description
DRUG	Botulinum toxin A	Intradermal botulinum toxin A was applied to the treatment side
DRUG	Placebo	NaCl was injected into the placebo side

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2024-03-26
• Last updated: 2024-03-29

Locations

1 site across 1 country: Turkey (Türkiye)