Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Erythematotelangiectatic Rosacea Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06331533
• Other study ID #: IstanbulTRH1
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2024
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Rosacea

Intervention

Drug:
• Botulinum toxin A
Intradermal botulinum toxin A was applied to the treatment side
• Placebo
NaCl was injected into the placebo side

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evaluation of erythema using mexameter	Evaluation of the effect of intradermal BoNT-A treatment on the objective erythema value measured by mexameter.	One month
Primary	Evaluation of erythema by dermatoscopy	Evaluation of the effect of intradermal BoNT-A treatment on dermatoscopic background erythema.	One month
Secondary	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