Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type APhase 4NCT07388927

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

A Phase 4 study testing Hirudoid (heparinoids) ointment, 3mg/g in people with Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A and Crow's Feet Lines, run by DKSH Management (Thailand) Limited.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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'). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines, Lateral Canthal Lines, LCL
What is being tested?: Hirudoid (heparinoids) ointment, 3mg/g
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: Feb 2026to Apr 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

About this study

Official title: Effectiveness of Hirudoid on Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A - A Real-World Multicenter, Prospective, Interventional Study

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.

Read the 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.

Conditions: Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines, Lateral Canthal Lines, LCL
Being tested: Hirudoid (heparinoids) ointment, 3mg/g
Keywords: Hirudoid, Botox, botulinum toxin type A injection, Bruising, Periorbital rejuvenation, Ecchymosis, Lateral canthal lines, Crow's feet
Medical subject headings: Contusions, Ecchymosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hirudoid (heparinoids) ointment, 3mg/gDrug
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.

Study groups in NCT07388927
Study group	Role	What they receive
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). Receives: Drug: Hirudoid (heparinoids) ointment, 3mg/g

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 7 post-procedure with botulinum toxin type A

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2026Apr 2026

First posted5 Feb 2026
Study startFeb 2026 (estimated)
Primary completionMar 2026 (estimated)
Study completionApr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07388927
Sponsor's protocol ID: DKS-HIRUDOID-RWE
Status last verified: Jan 2026
First submitted: 30 Dec 2025
Last updated: 5 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Hirudoid on Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A - A Real-World Multicenter, Prospective, Interventional Study
ClinicalTrials.gov ID: NCT07388927
Acronym / sponsor ID: DKS-HIRUDOID-RWE
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: DKSH Management (Thailand) LimitedIndustry (pharma, biotech, devices)
Study start: Feb 2026 (estimated)
Primary completion: Mar 2026 (estimated)
Study completion: Apr 2026 (estimated)
First posted: 5 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Hirudoid	Experimental	Drug: Hirudoid (heparinoids) ointment, 3mg/gAll enrolled and eligible participants who are planning to receive botulinum toxin type A for lateral canthal lines will receive the study drug (Hirudoid).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hirudoid (heparinoids) ointment, 3mg/gThis 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.	Drug	Hirudoid

Primary outcome

Area (extent) of ecchymosis around the eye
Time frame: Day 7 post-procedure with botulinum toxin type A
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.

5 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Individual participant dataSharing planned: 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area (extent) of ecchymosis around the eye (time frame: Day 7 post-procedure with botulinum toxin type A). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07388927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.