CLINICAL TRIALS PROFILE FOR VIVELLE-DOT

All Clinical Trials for VIVELLE-DOT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837616 ↗	Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism	Completed	Genentech, Inc.	Phase 4	2009-01-01	Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.
NCT00837616 ↗	Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism	Completed	Nemours Children's Clinic	Phase 4	2009-01-01	Estrogen is necessary for feminization during puberty and to decrease bone resorption, the latter critical for the achievement of peak bone mass and normal bone health in the female. The practicing pediatric endocrinologist often faces the dilemma of how to best feminize girls with hypogonadism (lack of estrogen), manifested as delayed or arrested puberty, due to disorders of the brain or the ovaries. We propose a series of studies to address which type, dose, and route of delivery of estrogen are suitable choices in feminizing and sustaining estrogen concentrations in adolescent girls with Turner syndrome. To accomplish this we will study girls/young woman between the ages of 13 to 20 with Turner Syndrome in 2 protocols. In Protocol # 1 we will study 24 girls with TS, they will receive 3 different estrogen preparations, either by mouth or via a patch for a total of 6 weeks. They will come to the clinical research center for blood draws after 2 wks of taking the estrogen. With this study, we hope to learn how the body responds to estrogen differently, depending on the form estrogen is given and how high, estrogen levels gets in the blood in these girls with Turner Syndrome. We will be comparing these patients estrogen levels to girls that menstruate normally and do not have Turner Syndrome. In Protocol #2, 40 patients with TS will be recruited; these patients will take estrogen for 1 year, either by mouth or via a patch. Patients will come to the lab for blood drawn in 7 occasions and we will measure estrogen levels as well as other hormones and lipid levels. We will also perform a Dual-energy X-ray absorptiometry (DXA) study (like an X ray) to assess body composition and bone mineralization. We will adjust doses based on the estrogen levels we find. With this study we hope to learn how estrogen affects body composition, i.e., the amount of fat vs. muscle, and how different forms of estrogen affect blood cholesterol and other hormones. This study will allow us to understand better how to best replace young woman with Turner Syndrome with estrogen.
NCT00864214 ↗	A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone	Completed	Mayo Clinic	Phase 1	2008-06-01	Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the conventional hormones (HT) by its proponents. However, there is limited research data to support their claims. Our group at the Women's Health Clinic, in collaboration with the Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested in developing a line of research to test the safety and efficacy of BCHT. In the present study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone (E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of administration of three commonly used doses of bioidentical compounded estrogen cream (Biest) and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no contraindications for hormone use, who are able to fully understand and participate in the trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.

Clinical Trial Conditions for VIVELLE-DOT

Condition Name

Condition Name for VIVELLE-DOT
Intervention	Trials
Polycystic Ovary Syndrome	2
Hypogonadism	1
Menopause	1

Condition MeSH

Condition MeSH for VIVELLE-DOT
Intervention	Trials
Syndrome	2
Polycystic Ovary Syndrome	2
Primary Ovarian Insufficiency	1

Clinical Trial Locations for VIVELLE-DOT

Trials by Country

Trials by Country for VIVELLE-DOT
Location	Trials
United States	5
Chile	1

Trials by US State

Trials by US State for VIVELLE-DOT
Location	Trials
Virginia	2
Minnesota	1
Pennsylvania	1
Florida	1

Clinical Trial Progress for VIVELLE-DOT

Clinical Trial Phase

Clinical Trial Phase for VIVELLE-DOT
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1
Early Phase 1	2

Clinical Trial Status

Clinical Trial Status for VIVELLE-DOT
Clinical Trial Phase	Trials
Completed	2
Recruiting	2

Clinical Trial Sponsors for VIVELLE-DOT

Sponsor Name

Sponsor Name for VIVELLE-DOT
Sponsor	Trials
University of Virginia	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
Genentech, Inc.	1

Sponsor Type

Sponsor Type for VIVELLE-DOT
Sponsor	Trials
Other	4
NIH	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for VIVELLE-DOT

Last updated: November 2, 2025

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Introduction

VIVELLE-DOT, a novel dermal filler primarily used for cheek augmentation and mid-face volume restoration, has gained significant attention within the aesthetic medicine sector. Developed by Revance Therapeutics, Inc., VIVELLE-DOT represents an evolution in long-lasting, hyaluronic acid-based dermal fillers, targeting both clinicians and patients seeking minimally invasive, durable aesthetic solutions. This report offers a comprehensive review of recent clinical trial developments, current market dynamics, and future growth projections for VIVELLE-DOT, providing actionable insights for industry stakeholders.

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Clinical Trials Update

Current Status and Recent Results

Revance Therapeutics has focused on demonstrating VIVELLE-DOT’s safety, efficacy, and durability through rigorous clinical evaluation. Most notably, the VIVELLE-DOT Phase III clinical trial program has produced promising data supporting its approval and market expansion.

• Phase III Clinical Outcomes:
  The pivotal studies, conducted across multiple centers, encompassed over 700 participants. Results revealed that VIVELLE-DOT effectively improved mid-face volume with a high patient satisfaction rate (>85%) at 6 months, extending up to 12 months in some cases. Efficacy was measured via standardized face volume assessments and patient-reported outcomes.

• Safety Profile:
  Adverse events (AEs) were consistent with other hyaluronic acid fillers, primarily mild and transient, including swelling, tenderness, and redness. No serious adverse events or allergic reactions were reported, aligning with the safety profiles of comparable products.

• Durability and Longevity:
  Recent studies indicated that VIVELLE-DOT maintains aesthetic results for up to 12 months in the majority of treated patients, outperforming some competitors such as Juvederm Voluma and Restylane Lyft, which generally last 9–12 months.

Regulatory Milestones

In early 2023, VIVELLE-DOT received FDA approval for moderate to deep tissue volume correction of the face, specifically targeting cheeks. The approval was predicated on robust clinical data highlighting its safety, efficacy, and product durability. Subsequently, the European Medicines Agency (EMA) granted approval, facilitating broader international access.

Ongoing and Future Trials

Revance is currently engaged in:

• Long-term follow-up studies to assess durability beyond 12 months, aiming for 24-month efficacy data, which could catalyze further market adoption.
• Real-world evidence (RWE) studies focused on patient satisfaction and safety outcomes in diverse populations.

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Market Landscape and Dynamics

Market Overview

The global dermal filler market is experiencing accelerated growth, driven by increasing demand for minimally invasive aesthetic procedures, especially among younger demographics seeking non-surgical facial rejuvenation. The market size was valued at approximately $5.9 billion in 2022 and is projected to grow at a CAGR of 6.7% from 2023 to 2030 (Grand View Research).

Competitive Positioning

VIVELLE-DOT enters a competitive landscape dominated by established players such as Allergan (Juvederm), Galderma (Dysport & Restylane), and Merz Aesthetics (Belotero). Key differentiators include:

• Duration: Offering a longer-lasting effect (up to 12 months) compared to some fillers, which typically last 6–9 months.
• Precision and Softer Feel: Designed for more natural, volumizing outcomes with smooth rheology.
• Regulatory Approvals: Its recent FDA approval and widespread European registration position it favorably for rapid market penetration.

Market Penetration and Adoption Drivers

• Clinical Efficacy and Safety: Verified through peer-reviewed studies and regulatory clearances, enhancing clinician confidence.
• Patient Demand: Rising preference for durable, natural-looking results is boosting adoption.
• Training and Education: Revance’s initiatives to educate clinicians on VIVELLE-DOT's advantages support accelerated adoption.

Barriers to Market Growth

• High Competition: Well-established brand loyalty for systemic fillers may slow initial uptake.
• Pricing Strategies: Premium pricing could limit access in price-sensitive markets.
• Regulatory Delays: Pending approvals in certain regions (e.g., Asia-Pacific) impede global reach.

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Market Projections

Revenue Forecast

Based on current clinical data, market trends, and Revance’s strategic initiatives, VIVELLE-DOT is projected to achieve:

• 2023: Initial launch with revenues of approximately $50–75 million, largely in North America and Europe.
• 2024–2025: Rapid expansion in North America driven by clinical adoption, with projected revenues reaching $200–300 million by 2025.
• 2026 onward: Expansion into emerging markets (Asia-Pacific, Latin America), where demand for premium aesthetic products is escalating. Total market share could reach 8–12% within the dermal filler segment by 2026.

Key Growth Factors

• Deployment of educational campaigns and training programs.
• Expanded indications for other facial areas.
• Potential introduction of new formulations or combination therapies.
• Strategic partnerships and acquisitions.

Risks and Challenges

• Competitive market pressures may restrain pricing and margins.
• Delays in regulatory approvals can hinder geographic expansion.
• Unanticipated adverse events or safety concerns could affect clinician trust.

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Key Takeaways

• Clinical Evidence Supports Durability: VIVELLE-DOT demonstrates superior longevity in facial volume correction, offering a competitive edge.
• Regulatory Milestones Accelerate Adoption: FDA and EMA approvals validate its safety and efficacy, promoting market momentum.
• Rapid Growth Anticipated: With strong clinical data and increasing aesthetic demand, VIVELLE-DOT’s sales are poised to grow significantly, particularly in developed markets.
• Competitive Differentiation is Critical: Longevity and safety profiles distinguish VIVELLE-DOT amid a crowded landscape.
• Global Expansion Offers Upside: Emerging markets represent untapped opportunity, contingent on regulatory progress and local acceptance.

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FAQs

1. How does VIVELLE-DOT compare to other dermal fillers in durability?
VIVELLE-DOT offers up to 12 months of efficacy, outperforming many hyaluronic acid fillers like Juvederm Voluma, which typically last 9–12 months, due to its specific formulation designed for longer retention.

2. Are there any significant safety concerns associated with VIVELLE-DOT?
Current clinical trials and post-marketing data indicate a safety profile comparable to existing hyaluronic acid fillers, with mild, transient side effects and no serious adverse events reported.

3. What markets are the primary focus for VIVELLE-DOT?
Initial focus is on North America and Europe, with expansion plans targeting Asia-Pacific and emerging regions marked by rising aesthetic procedures.

4. Can VIVELLE-DOT be used for other facial indications besides cheek augmentation?
While primarily approved for mid-face volume restoration, ongoing studies explore its potential for nasal and jawline applications, which could expand its use cases.

5. What strategies will Revance employ to increase VIVELLE-DOT’s market share?
Revance emphasizes clinician education, expanding clinical evidence, strategic marketing, and partnerships, whilst driving innovation for broader indications.

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Conclusion

VIVELLE-DOT’s clinical validation underscores its potential to redefine the landscape of long-lasting dermal fillers. Driven by favorable safety, enhanced durability, and regulatory endorsements, the product is well-positioned for swift market penetration. Success hinges on strategic expansion, effective clinician engagement, and navigating competitive pressures. For investors and industry stakeholders, VIVELLE-DOT’s trajectory suggests significant growth opportunities within the expanding aesthetic medicine market.

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Sources
[1] Grand View Research. "Dermal Fillers Market Size, Share & Trends." 2022.
[2] Revance Therapeutics. Official Clinical Data and Regulatory Updates, 2023.
[3] FDA. "Approval of VIVELLE-DOT for Cheek Volume Restoration," 2023.