Interim data from two ongoing investigator-initiated trials highlight the role of Sculptra and Restylane in addressing aesthetic changes associated with weight loss medications and menopause – Galderma

Galderma issued new data from two investigator-initiated trials (IITs), demonstrating the power of Sculptra – the first proven regenerative biostimulator – and the company’s versatile hyaluronic acid injectable Restylane range, in addressing the aesthetic changes associated with menopause and medication-driven weight loss, for the face and body. Data includes an analysis from a first-of-its-kind study evaluating optimal treatment sequencing to enhance women’s skin during menopause, and an evaluation of the cellular makeup of fat in the abdomen following medication-driven weight loss.

The two IITs were designed and executed by Dr. Andreas Nikolis and Dr. Sabrina Fabi respectively. Galderma supported the IITs as part of its long‑standing commitment to understanding patients’ evolving needs and supporting to deliver the best solutions for optimal patient outcomes. This approach to evidence generation, informed by real‑world needs, and enabled by the broadest Injectable Aesthetics portfolio in the industry, is designed to support advancements at every stage of the patient journey.

Menopause: Dual‑sequence study shows meaningful skin quality improvements and growing patient satisfaction with both Restylane Skinboosters and Sculptra

New interim results from a nine‑month clinical sequencing IIT of women in menopause conducted by Dr. Andreas Nikolis, both on the face and the décolletage, demonstrated that the combination of Restylane Skinboosters and Sculptra drove progressive and meaningful improvements in skin quality, with the most pronounced gains in hydration seen when using Restylane Skinboosters first. Hydration is a critical factor in menopausal skin health, as highlighted in an international survey of peri- and post-menopausal women as within their top five skin concerns for face and their number one concern for body.

The data reinforce the relevance and synergistic effects of the two products, with Skinboosters driving faster extra-cellular matrix and elastin-associated effects to quickly deliver hydration and improvements in skin roughness, fine lines and other imperfections, and Sculptra delivering regenerative benefits across all three skin layers, helping to gradually restore volume, firmness, radiance and skin quality, and smoothing wrinkles and folds over time.

Results showed that facial hydration and measures of skin‑barrier function improved over time in both groups, and the improvements were mirrored by patient‑reported outcomes, with satisfaction scores rising consistently across the study and reaching high levels by Month 6. Together, these data show that both treatment sequences contribute to measurable improvements in skin health in women during menopause, and they provide insight into how the treatment protocol may be optimized for this specific patient group.

“Menopause is associated with a distinct and often under-recognized set of skin changes, including dryness, barrier dysfunction, and progressive declines in skin quality. This first-of-its-kind clinical study is helping address an important unmet need by generating objective data in a population that has historically been overlooked in aesthetic research. The interim findings are highly encouraging, demonstrating meaningful improvements in skin hydration and collagen-related skin quality over time. Equally important, these measurable clinical benefits are mirrored by rising patient satisfaction throughout the study. For clinicians, these early results offer valuable evidence-based insight into how we can better support aging menopausal patients with treatment strategies that are tailored to the biologic changes of this stage of life.”  said Dr. Andreas Nikolis,  Study Lead investigator and Board-Certified Plastic Surgeon,  Montreal Canada

Aesthetic changes associated with medication-driven weight loss: New insights on cellular changes underscore importance of regenerative treatments that work across skin layers

New interim IIT data show that in patients experiencing aesthetic changes in the abdomen associated with medication-driven weight loss, the cellular composition of adipose tissue is altered, offering a biological explanation for the volume changes increasingly reported by clinicians. This underscores the value of regenerative treatment approaches, to support a healthy-looking appearance following medication-driven weight loss. The IIT, conducted by Dr. Sabrina Fabi, evaluated 20 female patients with mild-to-moderate skin laxity on their abdomen.

Interim results demonstrated a statistically significant, four‑fold reduction in adipose‑derived stem cells (ADSCs), the regenerative cell population responsible for maintaining healthy fat tissue, when compared to those who were not taking prescription weight loss medication. Fibroblasts were preserved. These findings contribute to a broader understanding of how the skin profile in individuals experiencing aesthetic changes associated with medication-driven weight loss differs from those where changes are occurring naturally with age without having taken prescription weight loss medications, and highlight why patients may benefit from treatment plans that focus not just on replacing lost volume, but on supporting the tissues’ underlying regenerative capacity. With a unique poly-L-lactic acid (PLLA-SCA) formulation, Sculptra re-engages the skin’s renewal process, stimulating adipose tissue, collagen and elastin for healthy looking skin. Over the decades, it has evolved into a versatile treatment that delivers regenerative benefits across all three skin layers, helping to gradually restore volume, firmness, radiance and skin quality, and smoothing wrinkles and folds over time.

“Many people experiencing medication-driven weight loss report aesthetic changes that seem disproportionate to weight loss alone, and until now, we haven’t fully understood why. The findings from this IIT suggest shifts in the skin and adipose‑tissue profile that may help explain the volume‑related changes clinicians are seeing. By clarifying the biological underpinnings, we can better guide treatment planning, and the available science indicates that regenerative and adipose tissue‑stimulating treatments such as Sculptra, can play a critical role in supporting healthy‑looking volume and appearance. This insight gives clinicians a stronger, evidence‑based foundation for thoughtful, individualized treatment discussions with their patients across their weight loss journey.”  said Dr. Sabrina Fabi,   Study Lead investigator  and cosmetic  dermatologist, San Diego United States