Evaluation of the efficacy of intradermal onabotulinumtoxinA for the treatment of accordion (cheek) wrinkles: A 2-centre randomized double-blinded split face clinical trial

Phase 2

Recruiting

• Conditions: Presence of accordion (cheek) wrinkles; Skin - Other skin conditions

• Registration Number: ACTRN12614000196640
• Lead Sponsor: David Ellis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. All male and female patients between ages of 40 - 75 complaining of accordion wrinkles and keen for intervention only for the accordion wrinkles.
2. Accordion wrinkles of at least grade 1 at rest and/or on extreme smile.
3. Of sound mind and able to give consent.
4. Able to be followed up for duration of study.
5. Patients can have been their crow’s feet or squint lines treated anytime prior to start of trial. (Different sets of muscles involved and the location of our injections is of adequate distance from squint lines hence will not affect the outcome)
6. Patients that are on ASA 81mg must be off for 2 weeks.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.
2. Patients who have previous botulinum toxin A injections at the cheek area.
3. Patients who have previous allergy to botulinum toxin A.
4. Patients with previous ablative laser procedures in the cheek area.
5. Patients with non-ablative laser treatment in cheek area in the last 6 months.
6. Patients with incisional surgery in the cheek area.
7. Patients who have muscular or neurological diseases such as amyotrophic lateral sclerosis, myasthenia gravis, Lambert-Eaton Syndrome, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of accordion wrinkles graded on a 0 to 4 scale based on serial photographs taken at week 0, 2, 4, 8, 12, 16. This is assessed by the investigator who is blinded. [Week 0, 2, 4, 8, 12, 16.]

Secondary Outcome Measures

Name	Time	Method
Improvement in skin elasticity measured by a cutometer at week 0, 2, 4, 8, 12, 16.[Week 0, 2, 4, 8, 12, 16.];Patient's satisfaction score based on a scale of 1 to 10 at week 2, 4, 8, 12, 16.[Week 2, 4, 8, 12, 16.]