Evaluation of Efficacy and Safety of Botulinum Toxin Type A (StunnoxTM) for the treatment Of Glabellar Frown Lines and Forehead Lines

Introduction:

Facial wrinkles are classified as dynamic wrinkles that occur with facial expression and static wrinkles that appears at rest. Static wrinkles are caused by cutaneous sagging or a decrease in the subcutaneous fat layer and atrophy of the dermis. Dynamic wrinkles, caused by repeated muscular contraction, can be improved with botulinum toxin type A injection.

Forehead lines (FL) are caused by the contraction of the Occipitofrontalis muscle. The contraction of this muscle, which functions as the elevator of the forehead, lifts the eyebrows upwards and can cause forehead lines.

Glabellar complex causes Glabellar frown lines (GFL) which are the group of depressor muscles of the forehead, responsible for the frown lines of the forehead. GFL are generally created by the Procerus and the bilateral Corrugator supercilii muscles, where botulinum toxin type A injection is the most commonly performed non-surgical procedure worldwide.

Botulinum toxin type A, is widely used in cosmetic dermatology to treat glabellar frown lines and forehead lines. It works by blocking the release of acetylcholine, a neurotransmitter that causes muscle contractions. By relaxing the targeted muscles, it reduces the appearance of wrinkles. The effects typically appear within a few days and last for 3 to 4 months. Treatment involves small doses, carefully injected into the specific muscles responsible for the wrinkles. Side effects are usually mild, including pain or swelling at the injection site. Regular treatments are required to maintain results

Study design:

The proposed study is an open label prospective single arm study at one centre to study the onset of action and duration of effect of botulinum toxin type A in the study group followed up for 20 weeks.

Informed consent shall be taken for all patients.

Study duration: 20 weeks

Study population: 75 patients who attend clinic seeking the treatment who meet the inclusion criteria are selected for the study after informed consent.

Methodology

The study will be conducted in accordance with principles that have their origins in the Declaration of Helniski. Around 75 patients will be recruited for forehead lines & glabellar frown lines indications treatment and 50 patients who seeking for treatment will be enrolled in the study. A detailed medical history & information about procedures done previously will be recorded in the predesigned proforma. The severity of forehead lines will be assessed, using a facial wrinkle scale (FWS) with grades of 0 (none), 1 (mild), 2 (moderate), and 3 (severe) at rest and during elevated eyebrows & frowning. StunnoxTM is supplied in single-dose 50 Units and 100 Units per vial. Prior to intramuscular injection, StunnoxTM will be reconstituted with sterile, preservative-free 0.9% Sodium Chloride solution with 1.25 mL and 2.5 mL, respectively. For treatment of forehead lines injections will be given with the needle bevel tip up using “M’ or ‘W’- technique 1 cm inside the mid pupillary line and 1.5-2 cm above the eyebrow.  4 Units/0.1 mL of reconstituted Botulinum toxin type A into 5 sites in the Occipitofrontalis muscle for a total of 20 Units/0.5 ml will be injected.

For treatment of Glabellar frown lines five injection points will be used including two points in each Corrugator supercilii muscle and one point in the Procerus muscle. The maximum dose can be injected for treatment of glabellar frown lines is 20 Units. The assessment will be done at -1, 0, 1, 4, 8, 12, 16, & 20 weeks (8 visits). The record will be maintained in 3 Photographs in each visit. Frontal, 2 obliques at 45 degrees. Photographs shall be captured by iPhone 15 pro max/ Digital SLR.

The parameters will be statistically analysed.