A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A

DKSH Management (Thailand) Limited

Status and phase: Not yet enrolling; Phase 4

Conditions: Crow's Feet Lines; Lateral Canthal Lines, LCL; Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A

Treatments: Drug: Hirudoid (heparinoids) ointment, 3mg/g

Study type: Interventional

Funder types: Industry

Identifiers

NCT07388927

DKS-HIRUDOID-RWE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Hirudoid

Experimental group

Description:

All enrolled and eligible participants who are planning to receive botulinum toxin type A for lateral canthal lines will receive the study drug (Hirudoid).

Treatment:

Drug: Hirudoid (heparinoids) ointment, 3mg/g