Clinical trial NCT02907268: Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study
Official title: A Single Blind, Split-Face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Rhytids
Keywords: botulinum toxin type A, intradermal
Lead sponsor: ICLS Dermatology & Plastic Surgery
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs
timeFrame: Baseline and 2 weeks
measure: Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs
timeFrame: Baseline and 4 weeks
measure: Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs
timeFrame: Baseline and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ICLS Dermatology & Plastic Surgery
name: Sheetal Sapra, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sapra P, Demay S, Sapra S, Khanna J, Mraud K, Bonadonna J. A Single-blind, Split-face, Randomized, Pilot Study Comparing the Effects of Intradermal and Intramuscular Injection of Two Commercially Available Botulinum Toxin A Formulas to Reduce Signs of Facial Aging. J Clin Aesthet Dermatol. 2017 Feb;10(2):34-44. Epub 2017 Feb 1.