Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study

ICLS Dermatology & Plastic Surgery

Status and phase: Completed; Phase 2

Conditions: Facial Rhytids

Treatments: Drug: abobotulinumtoxinA; Drug: onabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT02907268

ICLS-06-2013

Details and patient eligibility

About

A 16-week single-blind, split-face, randomized study. Each patient served as their own control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or right side of the face. Patients received intradermal BTXA injections at week 0 and intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface lift while reducing pore size and sebum production, as well as investigate the differences in effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and intramuscular injection methods.

Enrollment: 10 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects between ages of 35 to 65 years (inclusive) who exhibit static wrinkles in the following areas: glabella (forehead frowns), periorbital area (crows feet). Static wrinkles in additional areas of the face are also acceptable.
• Subject is willing to maintain the same skin care regimen throughout the study and has already maintained this skin care regime for 4 weeks prior to baseline.
• The subject is able to comply with study procedures and instructions and is committed to attend all study visits within the given timelines.
• Subject is judged to be a good candidate by study nurse upon identification of dynamic and/or static wrinkles in the areas of movement, and with a moderate amount of skin laxity.
• Subject is willing to use contraception
• A signed informed consent form by a subject able to give consent, prior to any study procedures are performed.

Exclusion criteria

• Sensitivity and/or contraindications to botulinum toxin A other ingredients contained in the botulinum toxin A products.
• Any medical condition, in the opinion of the investigator, that would interfere with safety or any study procedures (e.g. auto-immune disease, history of severe allergies, hypertrophic scars, immunotherapeutic treatment, inflammatory or infectious complaints at injection sites, unable to give consent)
• Treatment with botulinum toxin A injections in the neck or face within 1 year of baseline treatment
• Treatment with facial fillers less than 1 year prior to baseline
• Females of childbearing potential who are pregnant, breastfeeding or plan to get pregnant during the course of the study.
• Previous treatment with Lasers, Ultrasound Technology or Radio Frequency on the face and/or neck within 1 year prior to baseline.
• Treatment with Accutane (isotretinoin) or other oral medications for acne during 1 year prior to baseline.
• The use of anti-aging products containing retinol
• Known allergy to cow's milk protein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Treatment Arm A

Active Comparator group

Description:

The first treatment group received onabotulinumtoxinA (Botox) on the right side of their face and abobotulinumtoxinA (Dysport) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.

Treatment:

Drug: onabotulinumtoxinA

Drug: abobotulinumtoxinA

Treatment Arm B

Active Comparator group

Description:

The second treatment group received abobotulinumtoxinA (Dysport) on the right side of their face and onabotulinumtoxinA (Botox) on the left side of their face. Baseline treatment at Week 0 included the intradermal injection of onabotulinumtoxinA on one side of the face and abobotulinumtoxinA on the other. Patients were treated at Week 2 with traditional intramuscular injections consisting of onabotulinumtoxinA on the same side of their face as at Week 0 and abobotulinumtoxinA on the other side. Patients were treated based on individual need, and thus the treatment volumes were not controlled or standardized.

Treatment:

Drug: onabotulinumtoxinA

Drug: abobotulinumtoxinA