None listed
Conditions
Brief summary
This study will evaluate the safety and effectiveness of Relfydess (RelabotulinumtoxinA) for treating forehead lines using a randomised, single-blind, placebo-controlled design. This also seeks to inform best practices by comparing contraction-pattern driven versus standardised injection approaches and evaluating treatment durability following repeated administration. In Part A, participants will be randomised in a 4:1 ratio to receive either active or placebo and will be treated according to their forehead muscle contraction pattern. In Part B, those who first received active treatment will cross-over to receive a standardised injection approach, while those who first received placebo will receive active treatment, administered according to their forehead muscle contraction pattern.
Interventions
Eligible participants will undergo an initial (baseline) visual facial assessment to determine their forehead muscle contraction pattern. Based on this assessment, participants will be placed into one of four predefined frontalis muscle subgroups:
1. Full: Horizontal lines extending across the entire forehead.
2. Wing-shaped: Lines with central depression and lateral elevation.
3. Lateral: Lines in two lateral columns with absence of central lines.
4. Central: Short horizontal lines in the centr
Eligible participants will undergo an initial (baseline) visual facial assessment to determine their forehead muscle contraction pattern. Based on this assessment, participants will be placed into one of four predefined frontalis muscle subgroups: 1. Full: Horizontal lines extending across the entire forehead. 2. Wing-shaped: Lines with central depression and lateral elevation. 3. Lateral: Lines in two lateral columns with absence of central lines. 4. Central: Short horizontal lines in the central forehead with minimal lateral involvement. Each participant will receive two treatments, given six months apart (Parts A and B) and be followed for approximately 12 months. The investigator will administer the treatments by intramuscular injection. In Part A: Within each subgroup, participants will be randomised in a 4:1 ratio to receive either 30 units of relabotulinumtoxinA or placebo (saline). Participants will be treated according to their forehead muscle contraction pattern: 1. Full: Injections evenly distributed across the entire forehead. 2. Wing-shaped: Predominantly lateral injections, sparing the central frontalis to preserve brow elevation. 3. Lateral: Injections concentrated centrally to smooth the primary rhytids. 4. Central: Injections placed laterally, with minimal central dosing to reduce risk of brow ptosis. In Part B: Participants previously treated with relabotulinumtoxinA will be re-randomised in a 1:1 ratio to receive either a second dose of 30 units relabotulinumtoxinA or placebo (saline). Treatments will be administered in a generalised weakness injection pattern, designed to reduce activity across the entire frontalis muscle. Participants previously assigned to placebo in Part A will cross over to receive 40 units relabotulinumtoxinA. Treatments will be administered in a contraction-pattern driven injection approach (as previously described). Treatments will be administered at Day 1 and at Week 24. All participants will be reviewed at regular study visits: Weeks 1,4,12,16,24,25,28,36,40 and 48. The treatment visits (Day 1 and Week 24) are anticipated to take 30 minutes, allotter visits are anticipated to take 15 minutes.
Sponsors
The Dermatology Institute of Victoria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Moderate-to-severe forehead wrinkles No prior neurotoxin treatment within 6 months No contraindications to botulinum toxin type A Signed informed consent
Exclusion criteria
Pregnant or breastfeeding History of neuromuscular disorders History of adverse reactions to BoNT-A Received prior BoNT-A treatment within 6 months of trial enrollment Any pre-existing brow or lid ptosis Unwilling or unable to adhere to post-procedure care instructions or the follow-up schedule Any other condition that could make the patient noncompliant with the study procedures and/or study requirements, as judged by the Investigator.
Outcome results
None listed