Interim Data From Two Ongoing Investigator-Initiated Trials Highlight The Role Of Sculptra® And Restylane® In Addressing...

(MENAFN- AETOSWire) (BUSINESS WIRE ) -- Galderma (SIX: GALD), the pure-play dermatology category leader, today welcomes new data from two 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.^1-7 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.^1,2

The two IITs were designed and executed by Dr. Andreas Nikolis and Dr. Sabrina Fabi respectively.^1,2 Galderma proudly 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.¹ 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.^1,8,9

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.^1,3-7,10-12

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 6.¹ 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.¹

“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.” 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.² This underscores the value of regenerative treatment approaches, to support a healthy-looking appearance following medication-driven weight loss.² The IIT, conducted by Dr. Sabrina Fabi, evaluated 20 female patients with mild-to-moderate skin laxity on their abdomen.²

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.² 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.^2,13 Galderma is well‐positioned to address these alterations across the face and body, given its expertise in dermatology, specialized range of injectable treatments and skincare products, and patient‐centric approach developed in close collaboration with leading healthcare professionals. Sculptra is the first proven regenerative biostimulator, backed by over 25 years of clinical use.^3-7 With a unique poly-L-lactic acid (PLLA-SCATM) formulation, Sculptra re-engages the skin's renewal process, stimulating adipose tissue, collagen and elastin for healthy looking skin.^3-7 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.^3-7,12

“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.” DR. SABRINA FABI STUDY LEAD INVESTIGATOR AND COSMETIC DERMATOLOGIST SAN DIEGO, UNITED STATES

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: .

References

Nikolis A, et al. A comprehensive interim analysis of skin hydration, barrier function (TEWL), elasticity, and patient satisfaction across two treatment arms. Interim Data on File. April 2026

Fabi S, et al. Investigating the Impact of GLP-1 Receptor Agonists on Adipose-Derived Stem Cells. Interim Data on File. April 2026

U.S. Food and Drug Administration. Sculptra summary of safety and effectiveness data. Available online. Accessed April 2026.

Zhang Y, et al. In vivo inducing collagen regeneration of biodegradable polymer microspheres. Regen Biomater. 2021;8(5):rbab042. doi: 10.1093/rb/rbab042.

Waibel J, et al. A randomized, comparative study describing the gene signatures of poly-L-lactic acid (PLLA-SCA) and calcium hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress; February 3-6. 2024; Paris, France.

Huth S, et al. Molecular insights into the effects of PLLA-SCA on gene expression and collagen synthesis in human 3d skin models containing macrophages. J Drugs Dermatol. 2024;23(4):285-288. doi: 10.36849/JDD.7791.

Zubair R, et al. SPLASH: Split-body randomized clinical trial of poly-L-lactic acid for adipogenesis and volumization of the hip dell. Dermatol Surg. 2024;50(12):1155-1162. doi: 10.1097/DSS.0000000000004417.

Fabi G, et al. The potential role of biostimulators/dermal fillers to address menopause-related skin conditions. Poster presented at IMCAS; January 29-31, 2026; Paris, France.

Galderma. Data on file. Menopause Patient Survey.

Landau M, Fagien S. Science of Hyaluronic Acid Beyond Filling: Fibroblasts and Their Response to the Extracellular Matrix. Plast Reconstr Surg. 2015;136(5 Suppl.):188S–95S. doi: 10.1097/PRS.0000000000001823.

Allen J, Dodou K. Current Knowledge and Regulatory Framework on the Use of Hyaluronic Acid for Aesthetic Injectable Skin Rejuvenation Treatments. Cosmetics 2024;11(2):54. doi: 10.3390/cosmetics11020054

Widgerow A, et al. A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds. Poster presented at IMCAS World Congress, February 1-3, 2024, Paris, France

Ridha Z, et al. Decoding the Implications of Glucagon-Like Peptide-1 Receptor Agonists on Accelerated Facial and Skin Aging. Aesthet Surg J. 2024,Jun 14:sjae132.

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