Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Istanbul Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Erythematotelangiectatic Rosacea

Treatments: Drug: Placebo; Drug: Botulinum toxin A

Study type: Interventional

Funder types: Other

Identifiers

NCT06331533

IstanbulTRH1

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Botulinum toxin A

Experimental group

Description:

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.

Treatment:

Drug: Botulinum toxin A

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo