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

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

Study Overview

• Status: Completed
• Conditions: Erythematotelangiectatic Rosacea
• Intervention / Treatment: Drug: Botulinum toxin A; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-60 years old
• Erythematotelangiectatic rosacea subtype
• Willingness to participate in the research and providing informed consent

Exclusion Criteria:

• Patients under 18 years of age, over 60 years of age
• A rosacea subtype other than ETR
• History of using topical or systemic medications within the past two weeks due to rosacea or other dermatoses
• Known history of autoimmune disease
• History of neuromuscular disease
• History of facial botulinum toxin injection within the last six months
• Reporting allergy to the active ingredient
• Pregnant or breastfeeding patients
• Patients who do not accept treatment and follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin A; 30 points were marked on a randomly selected face half at 0.5 cm intervals. 0.5 U BoNT-A was injected into each point, making a total of 15 U BoNT-A.	Drug: Botulinum toxin A; Intradermal botulinum toxin A was applied to the treatment side; Other Names: Botox
Placebo Comparator: Placebo; 30 points were marked on a randomly selected face half at 0.5 cm intervals. 1.5 ml isotonic NaCl was injected intradermally into 30 points.	Drug: Placebo; NaCl was injected into the placebo side; Other Names: %0.9 Sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of erythema with Clinician's Erythema Assessment scale	The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale.	One month
Evaluation of erythema using mexameter	Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.	One month
Evaluation of erythema by dermatoscopy	Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change in vascular structure using videocapillaroscopy	The secondary objective of the study was to examine the effect of intradermal BoNT-A treatment on the Investigator Global Assessment (poorly defined vasculature and increased vessel diameter were considered poor response; IGA score=-1, localized or complete obliteration of vascular structures was considered good; IGA score=1, no change in vascular structures was considered no response; IGA score=0) scale developed using videocapillaroscopy.	One month

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: IstanbulTRH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No