Galderma’s Breakthrough Findings
Galderma (SWX:GALD), a global leader in dermatology, has announced the results of its Phase IIIb RELAX clinical trial, demonstrating the rapid onset, long-lasting efficacy, and high patient satisfaction of RelabotulinumtoxinA (Relfydess™) for treating frown lines (glabellar lines). These findings were presented at the International Master Course on Aging Science (IMCAS) 2025 annual congress in Paris, held from January 30 to February 1, 2025.
Trial Overview and Key Findings
The RELAX trial was a Phase IIIb, multicenter, randomized, double-blind, placebo-controlled study involving 132 adults with moderate-to-severe frown lines over a 12-month period. The results confirmed several key benefits:
- Rapid Onset: 40% of subjects reported aesthetic improvement by Day 1.
- Sustained Efficacy: Treatment effects lasted up to six months, with 57% maintaining improvement at Month 6 and 28% at Month 9.
- High Satisfaction Rates: 92% of participants were satisfied with their treatment outcome at Month 1, 69% at Month 6, and 60% at Month 12.
- Increased Confidence: Over 50% of subjects felt they looked great for their age and reported enhanced self-confidence at both Months 6 and 12.
- Strong Safety Profile: No treatment-related serious adverse events were observed.
Relfydess™: A Cutting-Edge Neuromodulator
RelabotulinumtoxinA, developed and manufactured by Galderma, is the first and only ready-to-use liquid neuromodulator created with PEARL Technology. This proprietary technology preserves molecule integrity, ensuring a highly active and complex-free formulation. Previously, Phase III READY clinical trial data had demonstrated:
- A rapid onset of effects as early as Day 1, reported by up to 39% of subjects.
- Long-lasting efficacy for up to six months, maintained by up to 75% of participants.
- Optimized volumetric dosing without reconstitution, allowing for ease of use and consistent treatment outcomes.
Regulatory Approvals and Market Expansion
Following a successful European Decentralized Procedure, Relfydess™ has received national approvals in 14 European countries. Additionally, the product has secured marketing authorizations from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the UK.
alderma Announces Positive Phase IIIb RELAX Trial Results at IMCAS 2025
Galderma (SWX:GALD), a global leader in dermatology, has shared promising findings from its Phase IIIb RELAX clinical trial at the International Master Course on Aging Science (IMCAS) 2025 annual congress in Paris. The study demonstrated that RelabotulinumtoxinA (Relfydess™) provides rapid onset, long-lasting efficacy, and high patient satisfaction for treating frown lines (glabellar lines).
Key Findings from the RELAX Study
The RELAX trial was a randomized, double-blind, placebo-controlled study evaluating 132 adults with moderate-to-severe frown lines over a 12-month period. The results confirmed several key benefits:
- Fast-Acting Results: 40% of subjects reported visible aesthetic improvement by Day 1.
- Extended Efficacy: Treatment effects IMCAS lasted up to six months, with 57% maintaining improvement at Month 6 and 28% at Month 9.
- High Patient Satisfaction: 92% of participants were satisfied at Month 1, 69% at Month 6, and 60% at Month 12.
- Boosted Self-Confidence: Over 50% of subjects reported feeling more confident and looking great for their age at both Month 6 and Month 12.
- Well-Tolerated Treatment: No treatment-related IMCAS serious adverse events were observed.
Relfydess™: A Breakthrough in Aesthetic Medicine
RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator developed by Galderma. It utilizes PEARL Technology, designed to preserve molecule integrity and ensure a highly active, complex-free formulation.
Previous Phase III READY clinical trial data had demonstrated:
- A rapid onset of effects as early as Day 1, reported by up to 39% of subjects.
- Long-lasting efficacy up to six months, with 75% of patients maintaining improvement.
- Optimized volumetric dosing without IMCAS reconstitution, increasing ease of use and consistency in treatment outcomes.
Regulatory Approvals and Global Expansion
Following a successful European Decentralized Procedure, Relfydess™ has received national approvals in 14 European countries. In addition, the product has obtained marketing authorizations from Australia’s Therapeutic Goods Administration IMCAS and the Medicines and Healthcare products Regulatory Agency in the UK.
Galderma’s Commitment to Dermatology Innovation
Galderma continues to lead the dermatology sector with a science-driven approach, offering innovative solutions in Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. With a presence in approximately 90 countries, the company remains dedicated to advancing dermatology and delivering superior outcomes for consumers and healthcare IMCAS professionals alike.
For more information, visit www.galderma.com.
References
- Prather HB, et al. Efficacy and safety of a novel liquid botulinum toxin, RelabotulinumtoxinA, for glabellar and lateral canthal lines. Presented at ASDS 2024; October 17-20, 2024; Orlando, FL.
- Ibrahim SF, et al. RelaBoNT-A treatment of glabellar and lateral canthal lines across different ethnicities. Presented at ASDS 2024; October 17-20, 2024; Orlando, FL.
- Sundberg AL, Stahl U. High-purity BoNT-A1 in liquid formulation. Presented at TOXINS 2021; January 16-17, 2021; virtual meeting.
- Do M, et al. Purification process of complex-free IMCAS highly purified BoNT-A1. Presented at TOXINS 2022; July 27-30, 2022; New Orleans, LA.
- Persson C, et al. Treatment experience with ready-to-use IMCAS AbobotulinumtoxinA vs. powder botulinum toxin for glabellar lines. Abstract presented at TOXINS 2024; January 17-20, 2024; Berlin.
- Literature search conducted in May 2023 across PubMed, ClinicalTrials.gov, and EudraCT.
- Galderma. Data on file. Clinical Study Report for Protocol QM111: RELAX
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