A Phase 4 interventional study of Hirudoid (heparinoids) ointment, 3mg/g in Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines and Lateral Canthal Lines, LCL, sponsored by DKSH Management (Thailand) Limited. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by DKSH Management (Thailand) Limited · Phase 4, Interventional, and Supportive care
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.
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.
43 studies on the registry are indexed under Contusions; 8 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 31 interventional studies indexed under Contusions.
Browse Contusions studies →This is the only study on the registry with DKSH Management (Thailand) Limited as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: Day 7 post-procedure with botulinum toxin type A
Area (extent) of ecchymosis around the eye
Area (extent) of ecchymosis around the eye with Hirudoid versus 'no treatment' on days 1, 2, 5 and 10 post-procedure with botulinum toxin type A, using the methodology described for primary endpoint. 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.
Time frame: Days 1, 2, 5 and 10 post-procedure with botulinum toxin type A
Intensity of ecchymosis around the eye
Intensity of ecchymosis around the eye with Hirudoid versus 'no treatment' on days 1, 2, 5, 7 and 10 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 against a 5-item scoring system (adapted from Rostami et al. 2020) for assessing the intensity of ecchymosis around the eye, where higher scores indicate greater post-procedure bruising. Rating: 0 (no colour change); 1 (yellowish colour change); 2 (light purple); 3 (dark purple); 4 (very dark purple). A separate independent assessment will take place for each image, by a second physician who is blinded to initial results.
Time frame: Days 1, 2, 5, 7 and 10 post-procedure with botulinum toxin type A
Duration (days until resolution) of ecchymosis
Duration (days until resolution) of ecchymosis with study treatment versus 'no treatment' assessed based on visual assessment by the physician using the using the scoring system adapted from Rostami et al. 2020. Patients will be instructed to take daily photographs of both sides of face, which will be shared with clinician and analysed against a 5-item scoring system for assessing the intensity of ecchymosis around the eye, where gradual reduction of ratings indicate resolution. Rating: 0 (no colour change); 1 (yellowish colour change); 2 (light purple); 3 (dark purple); 4 (very dark purple). A separate independent assessment will take place for each image, by a second physician who is blinded to initial results.
Time frame: Day 1 to Day 10 post-procedure with botulinum toxin type A
Global patient satisfaction
Global patient satisfaction relating to the impact and outcomes of Hirudoid treatment, evaluated by a 5-point Likert-scale questionnaire (1=very dissatisfied to 5=very satisfied) on day 7 post-procedure.
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
Incidence and type of local adverse events will be summarized descriptively using count and percentages for both the arms.
Time frame: Day 1 to Day 10 post-procedure with botulinum toxin type A
No study locations are listed for this record.
Plan to share: Yes — Complete data will not be shared with any other institution or personnel in a way which can expose the identity of participating patients. All records identifying the patient will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. 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.
Supporting information: Clinical study report
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.
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Mar 2026, 1 month later.
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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