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NCT Number: NCT06331533

Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

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

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Key information

Conditions

Erythematotelangiectatic Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin A

Drug

Intradermal botulinum toxin A was applied to the treatment side

Other names: Botox

Placebo

Drug

NaCl was injected into the placebo side

Other names: %0.9 Sodium chloride

Primary outcomes

  1. Assessment of erythema with Clinician's Erythema Assessment scale

    Time frame: One month

    The effect of intradermal BoNT-A treatment on facial erythema was evaluated using the Clinician's Erythema Assessment scale.

  2. Evaluation of erythema using mexameter

    Time frame: One month

    Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.

  3. Evaluation of erythema by dermatoscopy

    Time frame: One month

    Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.

Secondary outcomes

  1. Evaluation of the change in vascular structure using videocapillaroscopy

    Time frame: One month

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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