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

NCT07388927 | Not Yet Recruiting Phase 4

• 1 other identifier: DKS-HIRUDOID-RWE
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

Hirudoid; Botox; botulinum toxin type A injection; Bruising; Periorbital rejuvenation; Ecchymosis; Lateral canthal lines; Crow's feet

Outcome Measures

Primary Outcomes (1)

• Area (extent) of ecchymosis around the eye

  Area (extent) of ecchymosis around the eye with Hirudoid versus 'no treatment' on day 7 post-procedure with botulinum toxin type A for the treatment of lateral canthal lines. Patients will be instructed to take daily photographs of both sides of face, which will be shared with clinician and analysed with online software to measure area of bruising using a freehand selection tool to trace the border. Results are to be inputted into the electronic case record form in cm2. A separate independent assessment will take place for each image, by a second physician who is blinded to initial results.

  Day 7 post-procedure with botulinum toxin type A

Secondary Outcomes (5)

• Area (extent) of ecchymosis around the eye

  Days 1, 2, 5 and 10 post-procedure with botulinum toxin type A

• Intensity of ecchymosis around the eye

  Days 1, 2, 5, 7 and 10 post-procedure with botulinum toxin type A

• Duration (days until resolution) of ecchymosis

  Day 1 to Day 10 post-procedure with botulinum toxin type A

• Global patient satisfaction

  Day 7 post-procedure with botulinum toxin type A

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Day 1 to Day 10 post-procedure with botulinum toxin type A

Study Arms (1)

Hirudoid

EXPERIMENTAL

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

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

Interventions

Hirudoid (heparinoids) ointment, 3mg/g DRUG

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 right) for all eligible participants, 30 minutes before the botulinum toxin type A injection procedure, and three times a day, starting 24 hours after the procedure, until post-procedure Day 10. A 2 centimetre ribbon of Hirudoid will be applied to the affected area (i.e. the lateral canthal lines injection site), and massaged into skin until absorbed.

Hirudoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DKSH Management (Thailand) Limited: lead

MeSH Terms

Conditions

Contusions; Ecchymosis

Interventions

Hirudoid; Heparinoids; Ointments

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be an intra-individual comparison study, where the study drug will be applied to one side of the face of participants, and the other half of the face will receive no treatment. A computer-generated random sheet will be used to assign the right/left side of the face for treatment, to avoid allocation bias and to improve scientific validity.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Tentative dates available: May 2026 to May 2026 No end date.
• Access Criteria: A summary of the pooled participant study data based on the approved statistical analysis plan, will be shared in the form of an abbreviated clinical study report. This clinical study report document will be available to researchers on email request to the corresponding author of the manuscript.