Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-06-01

Brief Summary

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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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Detailed Description

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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

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Erythematotelangiectatic Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Randomized, split face, efficacy study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

Botulinum toxin A

Intervention Type DRUG

Intradermal botulinum toxin A was applied to the treatment side

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl was injected into the placebo side

Interventions

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Botulinum toxin A

Intradermal botulinum toxin A was applied to the treatment side

Intervention Type DRUG

Placebo

NaCl was injected into the placebo side

Intervention Type DRUG

Other Intervention Names

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Botox %0.9 Sodium chloride

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No