Botulinum Toxin to Improve Lower Blepharoplasty Scar

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 4

Conditions: Other Degenerative Disorders of Eyelid and Periocular Area

Treatments: Other: Normal Saline; Drug: Botulinum Toxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02786550

104-8788A3

Details and patient eligibility

About

The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle) and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty incision whereas the scar is more visible on patient.

The main aim of this trial is to investigate whether the injection of Botulinum toxin into the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower blepharoplasty.

Full description

The main aim of this double blind randomized trial is to examine whether immediate post-operative injection of botulinum toxin into lateral part of bilateral orbicularis oculis muscles (the injection technique of crow feet) can improve scar formation for lower blepharoplasty patients.

This is a double blind randomized controlled trial primarily designed to compare the scarring after secondary cleft lip repair with immediate post-operative botulinum toxin injection into the into bilateral lateral orbicularis oculi muscles in patients with lower blepharoplasty. There will be 2 main groups in this study:-

1. Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.
2. Control group (Group II): There will be the same amount of normal saline injection after lower blepharoplasty.

Follow-up Assessments Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month Follow Up.

Visual analogue scale They were asked to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).

Photographic measurement:

A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured.

Chi-square will be used to analyze the demographic data ( i.e. Gender) The Independent T-Student test will be used to analyze the statistical significance between the two groups.

The dosage of Botox that the investigators use for crowfeet is very tiny. And this is a common clinic practice. Systemic insult is unlikely to happen. If an allergic reaction occurred it will be treated according to the severity of allergy and Diphenhydramin PO or IV form or systemic corticosteroid will be given.

Enrollment: 40 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult ≥ 45 years old.
2. Lower eyelid Rhytidosis and dermatochalasis.
3. Lower eyelid steatoblepharon and pronounced nasojugal groove
4. Written informed consent given by patient.

Exclusion criteria

1. Less than 45 years old
2. Without written informed consent.
3. Combined other craniofacial anomalies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Botulinum Toxin

Experimental group

Description:

Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle. Intervention: Botulinum toxin injection

Treatment:

Drug: Botulinum Toxin

Normal saline

Placebo Comparator group

Description:

Immediately after lower blepharoplasty surgery 3 injections of same amount of normal saline over lateral part of orbicularis oculi muscle. Intervention: Normal saline injection

Treatment:

Other: Normal Saline