Botulinum Toxin Protocol

HAUS OF ÄSTHETIK

BOTULINUM TOXIN TREATMENT PROTOCOL

(BOTOX, BOCOUTURE, XEOMIN, LETIBO, AZZALURE, DYSPORT)

DATE OF IMPLEMENTATION:1ST APRIL 2025

REVIEW DATE: 1ST APRIL 2026

VERSION NUMBER 1.1

INTRODUCTION

This Botulinum Toxin Treatment Protocol ensures safe, effective, and compliant administration of Botulinum Toxin Type A (including Botox, Bocouture, Xeomin, Letibo, Azzalure, Dysport) at HAUS OF ÄSTHETIK. It aligns with CQC, Save Face, NICE, GMC, NMC, MHRA, and internal clinic policies regarding medicines management, record keeping, safeguarding, and delegation. Only qualified and insured practitioners with appropriate accredited training may carry out these treatments under the supervision of a registered prescriber. A face-to-face consultation with a prescriber is mandatory before initiating treatment.

INDICATIONS FOR TREATMENT

1. Licensed Indications:

Examples include glabellar lines and lateral canthus lines as authorised by specific product licenses (varies by brand). Practitioners must be familiar with each brand’s approved uses.

2. Off-Label Indications:

May include frontalis lines, bunny lines, DAO, masseter hypertrophy, platysma bands, and other areas deemed clinically appropriate. If used off-label, the patient must be informed, and written consent clearly stating off-label use must be obtained.

STORAGE REQUIREMENTS

All Botulinum Toxin vials must be kept in a locked refrigerator at 2–8°C (or frozen if stipulated by the manufacturer). Daily maximum/minimum temperature logs must be maintained. Sterile 0.9% sodium chloride or bacteriostatic saline is stored securely. Once opened, the date must be noted, and if partially used, it should be refrigerated accordingly. Any failed vacuum or expired product must be discarded and logged as per our Medicines Management Policy.

STAFF COMPETENCY AND DELEGATION

Practitioners must be doctors, dentists, registered nurses, or qualified aesthetic practitioners who have completed accredited Botulinum Toxin training and hold valid indemnity cover. Non-prescribing practitioners may only administer treatments under a Delegation of Administration of Prescription-Only Medicines policy with clear guidance from a registered prescriber who holds ultimate clinical responsibility.

INCLUSION CRITERIA

• Adults (18+).

• Good general health, no significant contraindications, stable mental health, and realistic treatment expectations.

• Indications such as moderate to severe glabellar lines, crow’s feet, frontalis lines, or other off-label facial treatments if approved by the prescriber.

EXCLUSION CRITERIA

• Under 18 (prohibited by the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021).

• Pregnancy or breastfeeding.

• Known allergy to Botulinum Toxin or excipients.

• Neuromuscular disorders (for example, Myasthenia Gravis).

• Concurrent use of medications that could potentiate or interfere with Botulinum Toxin.

• Active infection or inflammation at injection sites.

• Unrealistic expectations or suspected Body Dysmorphic Disorder.

PRE-TREATMENT ASSESSMENT

• Face-to-face consultation with a registered prescriber is mandatory, covering patient history, medication review, and psychosocial assessment.

• Full medical record update and photographic documentation are required.

• Informed consent must detail risks, benefits, alternatives, off-label status, brand used, and potential complications.

RECONSTITUTION AND DILUTION

Wash hands thoroughly. Disinfect vial stoppers with 70% isopropyl alcohol. Slowly inject the appropriate volume of diluent. Gently swirl until dissolved. If the vacuum is absent, discard the vial and log the batch number. Always verify the final solution is clear before use.

Below is a guide for reconstituting commonly used toxins (Botox, Bocouture, Xeomin, Letbo) with 1 mL or 1.25 mL of saline or bacteriostatic saline.

	50-UNIT VIAL	BOTOX 100-UNIT VIAL
1 ML	5 units per 0.1 mL	10 units per 0.1 mL
1.25ML	4 units per 0.1 mL	8 units per 0.1 mL
2ML	2.5 units per 0.1 ml	5 units per 0.1 mL
2.5ML	2 units per 0.1 ml	4 units per 0.1 mL

 

AZZALURE

Usually 125 Speywood units per vial (equivalent to ~50 standard Botox units).

• 1 mL → ~12.5 Speywood units per 0.1 mL (~5 standard Botox units)

• 1.25 mL → ~10 Speywood units per 0.1 mL (~4 standard Botox units)

DYSPORT

Typically 300 or 500 Dysport units per vial. Dysport units are not equivalent to Botox units.

300-UNIT VIAL

• 1 mL → 30 Dysport units per 0.1 mL

• 1.25 mL → 24 Dysport units per 0.1 mL

500-UNIT VIAL

• 1 mL → 50 Dysport units per 0.1 mL

• 1.25 mL → 40 Dysport units per 0.1 mL

TREATMENT ADMINISTRATION

If topical anaesthetic is used, thoroughly remove it prior to injection. Cleanse and disinfect the skin, ensuring no pencil marks enter the puncture site. Use a 30G needle (or as recommended) for injection, aspirating where indicated. Inject slowly, monitoring for immediate adverse events such as vascular compromise or allergic reaction. Document all injection details, including product brand, batch number, expiry date, final dilution, dose per site, injection technique, and any immediate patient feedback.

POST-PROCEDURE

Discard sharps in a sharps bin. Neutralise residual Botulinum Toxin with 0.5% bleach solution before discarding vials. Clean the treated area, remove gloves, wash hands, and update the patient’s records with complete procedural details. Provide written aftercare instructions advising the patient to avoid intense heat, strenuous activity, or lying flat for several hours. Offer a review appointment at two to three weeks to assess outcomes or perform touch-ups if required.

MEDICAL RECORD KEEPING

Comprehensive documentation is mandatory, including patient identifiers, brand, dose, batch number, consent forms, photographic evidence, and notes on any complications or incidents. This must comply with HAUS OF ÄSTHETIK’s Record Keeping Policy and UK GDPR regulations.

ADVERSE EVENTS

Minor side effects, such as bruising, mild pain, or transient headache, should be discussed pre-treatment. More serious complications, including ptosis, brow droop, unexpected asymmetry, infection, or anaphylaxis, must be escalated to the prescriber immediately. Severe incidents may require reporting via the MHRA Yellow Card scheme, and the clinic’s insurer must be informed if a complaint or claim is likely. Practitioners must record all adverse events and follow the clinic’s Complications and Incident Reporting Policy.

QUALITY ASSURANCE

Routine audits will assess compliance with this protocol and track patient outcomes. Practitioners must regularly attend CPD activities to maintain skill levels and stay abreast of clinical evidence or regulatory changes. The protocol is reviewed annually or sooner if updated by external guidance or internal risk assessments.

CONCLUSION

By adhering to this Botulinum Toxin Treatment Protocol, HAUS OF ÄSTHETIK ensures consistent patient safety, optimal clinical outcomes, and professional standards in line with best practice. All staff must comply with the procedures outlined and remain accountable for their practice under the clinic’s governance framework and UK regulatory requirements.