A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hirudoid (heparinoids) ointment, 3mg/g.
- Who it may be relevant to
- Registry conditions: Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines, Lateral Canthal Lines, LCL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Hirudoid on Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A - A Real-World Multicenter, Prospective, Interventional Study
Overview
Botulinum toxin type A (commonly referred to as 'Botox') injections are a treatment that dermatologists regularly use to smoothen wrinkles such as 'Crow's feet', to rejuvenate the skin surrounding the eye (the 'periorbital region'). However, botulinum toxin type A can be associated with injection-site bruising that may take up to 2 weeks to heal. Hirudoid, an ointment that is applied to the skin, has been shown to reduce the severity of swelling and bruising after facial cosmetic procedures. The objective of this study is to study the effectiveness of Hirudoid in reducing the severity of bruising following the use of botulinum toxin type A for periorbital rejuvenation of Crow's feet in adult patients. The knowledge gained from this study can help to develop an effective medicated skincare regimen that helps to minimize the complications of botulinum toxin type A and speed up recovery time, which may be of benefit to patients who receive botulinum toxin type A injections for treatment of Crow's feet.
Detailed description
This is an investigator-initiated, real-world, multicenter, prospective, interventional study to assess the effectiveness of topical Hirudoid for both preventing, and reducing the severity (intensity and extent) of ecchymosis after periorbital rejuvenation with botulinum toxin type A. This will be an intra-individual comparison study, where the study drug will be applied to one side of the face, and the other half of the face will receive no treatment.
Planned follow up is up to 10 days with assessments scheduled at Days 1, 2, 5, 7, and 10 post-botulinum toxin type A injection. The total number of mandatory in-person visits would be 2, including a visit on the day of botulinum toxin type A injection (Day 0), and a follow-up visit on Day 7 post-procedure.
Interventions
- Drug Hirudoid (heparinoids) ointment, 3mg/g
This study is to observe the effectiveness of Hirudoid on ecchymosis after treatment of Crow's feet with botulinum toxin type A. Hirudoid is a topical treatment that is indicated for the soothing relief of superficial bruising and haematoma. It may potentially reduce the severity (intensity and extent) of bruising, and/or increase the speed of resolution of bruising after periorbital botulinum toxin A injection. Hirudoid will be applied to one side of the face (randomized allocation of left or
Primary outcome measures
- Area (extent) of ecchymosis around the eye [Time frame: Day 7 post-procedure with botulinum toxin type A]
Secondary outcome measures (5)
- Area (extent) of ecchymosis around the eye [Time frame: Days 1, 2, 5 and 10 post-procedure with botulinum toxin type A]
- Intensity of ecchymosis around the eye [Time frame: Days 1, 2, 5, 7 and 10 post-procedure with botulinum toxin type A]
- Duration (days until resolution) of ecchymosis [Time frame: Day 1 to Day 10 post-procedure with botulinum toxin type A]
- Global patient satisfaction [Time frame: Day 7 post-procedure with botulinum toxin type A]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: Day 1 to Day 10 post-procedure with botulinum toxin type A]
Eligibility criteria
Inclusion criteria
- Adults (age ≥18 years) undergoing periorbital rejuvenation procedures with botulinum toxin type A (e.g., improvement in the appearance of moderate-to-severe lateral canthal lines)
- Patients willing to participate in the study and return for the scheduled follow-up visit, be photographed as a part of the study procedures, and sign the informed consent form
Exclusion criteria
- Known allergy to Hirudoid or any components of Hirudoid
- Known allergy to Botulinum toxin type A
- Previous cosmetic surgery or visible scars in the treatment area
- Severe atrophy or weakness in the target muscles
- Use of local anesthetic prior to Botulinum toxin type A administration
- Current or recent use of anticoagulant or corticosteroid therapy
- Current cigarette smoker
- History of clotting or coagulation disorders
- History of cardiovascular, metabolic, endocrine, liver or renal diseases or any underlying medical condition that may interfere with the study procedures or assessments
- Patients suffering from any psychiatric condition
- Patients taking any agent (e.g., aminoglycoside antibiotics) or suffering from any disorder (e.g., myasthenia gravis, Eaton-Lambert syndrome) that may interfere with neuromuscular function
- Pregnant or lactating women
- Patients unwilling to be photographed or sign the informed consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07388927 · DKS-HIRUDOID-RWE