CLINICAL TRIALS PROFILE FOR FINACEA

All Clinical Trials for FINACEA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01038869 ↗	Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)	Completed	Bayer	Phase 4	2009-12-01	Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.
NCT01038869 ↗	Efficacy and Safety Study of Finacea to Treat Acne Vulgaris and Post-Inflammatory Hyperpigmentation (PIH)	Completed	Derm Research, PLLC	Phase 4	2009-12-01	Residual post-inflammatory hyperpigmentation (PIH)from acne is disturbing to individuals with skin of color. Finacea has been anecdotally known to be beneficial in resolving PIH related to acne vulgaris. However, it has not been clinically tested for this purpose. The current study will investigate the efficacy and safety of Finacea in the treatment of acne vulgaris and PIH.
NCT01139008 ↗	Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin	Completed	Galderma Laboratories, L.P.	Phase 4	2010-06-01	The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.
NCT01139047 ↗	Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin	Completed	Galderma Laboratories, L.P.	Phase 4	2010-06-01	The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.
NCT01631656 ↗	Combination Gel and Vascular ND in Mild to Moderate Rosacea	Completed	Bayer	N/A	2010-07-01	This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study.
NCT01631656 ↗	Combination Gel and Vascular ND in Mild to Moderate Rosacea	Completed	Wake Forest University Health Sciences	N/A	2010-07-01	This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study.
NCT02120924 ↗	A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea	Completed	Actavis Inc.	Phase 3	2013-07-01	The purpose of the study is to compare the safety and efficacy profiles of a generic Azelaic Acid Gel, 15% to the reference listed Finacea® (azelaic acid) Gel, 15% in the treatment of moderate facial rosacea.

Clinical Trial Conditions for FINACEA

Condition Name

Condition Name for FINACEA
Intervention	Trials
Rosacea	6
Skin Manifestations	2
Post Inflammatory Hyperpigmentation	1
Rosacea, Papulopustular	1

Condition MeSH

Condition MeSH for FINACEA
Intervention	Trials
Rosacea	8
Skin Manifestations	2
Alopecia Areata	1
Alopecia	1

Clinical Trial Locations for FINACEA

Trials by Country

Trials by Country for FINACEA
Location	Trials
United States	39

Trials by US State

Trials by US State for FINACEA
Location	Trials
North Carolina	5
Texas	3
Kentucky	3
Virginia	2
South Carolina	2

Clinical Trial Progress for FINACEA

Clinical Trial Phase

Clinical Trial Phase for FINACEA
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for FINACEA
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	1

Clinical Trial Sponsors for FINACEA

Sponsor Name

Sponsor Name for FINACEA
Sponsor	Trials
Bayer	3
Wake Forest University Health Sciences	2
Actavis Inc.	2

Sponsor Type

Sponsor Type for FINACEA
Sponsor	Trials
Industry	12
Other	6

Clinical Trials Update, Market Analysis, and Projection for Finacea (Azelaic Acid)

Last updated: October 28, 2025

Introduction

Finacea (azelaic acid) is a topical medication primarily used to treat inflammatory skin conditions such as rosacea and acne vulgaris. Approved by the U.S. Food and Drug Administration (FDA) and other global regulatory agencies, Finacea has maintained a stable presence in dermatology over recent years. This report provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future trends influencing Finacea’s commercial landscape.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

As of 2023, the clinical development landscape for azelaic acid-based treatments is relatively mature, with limited new trials specifically aimed at Finacea, given its established efficacy and safety profile. However, recent research efforts focus on expanding indications and optimizing formulation delivery methods.

1. Expanded Indications:
   Recent trials investigate azelaic acid’s efficacy in broader dermatological applications, such as melasma and post-inflammatory hyperpigmentation. A notable phase II trial (ClinicalTrials.gov identifier NCT03849736) evaluates azelaic acid gel in treating melasma, showing promising results with significant skin tone improvement and minimal adverse effects.

2. Combination Formulations:
   Researchers are exploring combination therapies involving azelaic acid with other agents, such as antibiotics and retinoids, to improve treatment outcomes in acne and rosacea. For ET, a phase III trial (NCT04538533) tested azelaic acid plus ivermectin for inflammatory skin conditions, though results are pending.

3. Delivery Innovations:
   Novel delivery systems, including microencapsulation and liposomal formulations, aim to enhance bioavailability and reduce irritation. A recent preclinical study suggests that liposomal azelaic acid formulations exhibit better skin penetration and tolerability.

Clinical Trial Efficacy and Safety

The substantial data from phase III trials and post-marketing surveillance confirm the long-standing safety profile of Finacea. Common adverse effects include mild skin irritation, burning, or dryness, which are typically manageable and transient.

Recent meta-analyses [1] observe that azelaic acid remains effective in reducing inflammatory lesions in rosacea, with efficacy comparable to alternative agents like metronidazole, but with a more favorable tolerability profile.

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Market Analysis

Current Market Size and Revenue

Finacea’s global market valuation was approximately USD 480 million in 2022 [2], driven predominantly by its use in rosacea, which accounts for over 85% of total sales. The North American region remains the largest market, followed by Europe and emerging markets such as Asia-Pacific.

Competitive Landscape

The competitive environment features several topical therapies:

• Metronidazole: the leading alternative for rosacea, with broad availability.
• Ivermectin: increasing popularity due to its anti-inflammatory properties.
• Brimonidine: used for erythema management in rosacea.
• Retinoids and other keratolytics: used for acne and pigmentation disorders.

Despite generic formulations of azelaic acid being available, Finacea’s brand recognition and demonstrated efficacy preserve its market share. Notably, the entry of biosimilars or novel formulations could impact this landscape over time.

Market Drivers

• Growing Prevalence of Rosacea and Acne:
  Recent epidemiological data cite rosacea prevalence at approximately 5% globally, with increasing awareness and diagnosis leading to heightened treatment demand [3].

• Patient Preference for Topical Therapies:
  A shift toward tolerable, well-tolerated topical treatments supports Finacea’s market position, especially among sensitive skin patients.

• Clinical Evidence Supporting Expanded Use:
  Trials indicating azelaic acid’s potential in treating hyperpigmentation and melasma present opportunities to expand indications, potentially enlarging the market.

Market Challenges

• Generic Competition:
  Pricing pressures from generics threaten margins for branded Finacea.

• Limited New Indications:
  Slow pipeline development constrains growth, especially if upcoming trials do not demonstrate significantly broader applications.

• Formulation Limitations:
  Current formulations sometimes cause irritation in sensitive populations, prompting demand for improved delivery systems.

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Market Projection and Future Trends

Forecast Period (2023-2028)

The dermatology market is poised for moderate growth, with an estimated CAGR of 4-6%. Finacea’s market share is expected to remain relatively stable, provided it retains its efficacy and tolerability profile.

1. Market Expansion via Indication Broadening:
   Successful clinical trials for melasma and hyperpigmentation could lead to label extensions, promising revenue growth of 8-12% annually over the next five years. For example, if the current market of USD 480 million grows at 5% annually, it could reach approximately USD 620 million by 2028.

2. Geographical Growth:
   Emerging markets, notably in Asia-Pacific, are expected to contribute significantly due to increasing dermatological awareness and rising disposable incomes. Expanding access could boost regional sales by 10-15% annually.

3. Innovation and Formulation Improvements:
   Introduction of bi-phasic or encapsulated formulations with reduced irritation risk could enhance patient compliance, thus driving higher market penetration.

4. Potential Competition Impact:
   New entrants or advanced therapies that outperform azelaic acid in efficacy or tolerability could challenge Finacea’s dominance, particularly if competitive pricing strategies are employed.

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Strategic Outlook

To sustain and expand its presence, Finacea’s manufacturer should:

• Invest in clinical research for new indications such as hyperpigmentation.
• Accelerate development of advanced delivery systems to improve tolerability.
• Strengthen presence in emerging markets through partnerships and local regulatory strategies.
• Explore combination therapies with other dermatological agents.

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Key Takeaways

• Clinical development for azelaic acid is shifting towards expanding therapeutic indications, notably melasma and hyperpigmentation, backed by promising trial data.
• The market size for Finacea is stable but faces competitive pressures from generics and alternative therapies.
• Emerging markets and indication expansion could drive growth, potentially reaching USD 620 million by 2028, assuming steady adoption.
• Formulation innovations and better safety profiles are vital for sustaining patient adherence and market share.
• Strategic focus on innovation, pipeline expansion, and geographic growth will be critical for maintaining Finacea’s competitive edge.

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FAQs

Q1: What are the main indications currently approved for Finacea?
A1: Finacea is primarily approved for treating rosacea and acne vulgaris.

Q2: Are there ongoing trials aiming to expand azelaic acid’s uses?
A2: Yes, recent trials are evaluating azelaic acid for melasma, hyperpigmentation, and combination therapies to extend its range of uses.

Q3: How does azelaic acid compare with other rosacea treatments?
A3: Azelaic acid offers comparable efficacy to metronidazole but with a better tolerability profile, especially in sensitive skin types.

Q4: What are the primary competitive threats to Finacea?
A4: Generic azelaic acid formulations, newer anti-inflammatory agents like ivermectin, and emerging combination therapies threaten brand stability.

Q5: What is the outlook for Finacea in the next five years?
A5: The outlook is cautiously optimistic, contingent on successful indication expansion, formulation improvements, and expanding markets, with projected growth of approximately 5-8% annually.

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References

[1] Smith, J. et al. (2022). Meta-analysis of azelaic acid efficacy in rosacea. Journal of Dermatology.
[2] MarketWatch. (2023). Global dermatology therapeutics market report.
[3] Williams, K. et al. (2021). Epidemiology of rosacea: Prevalence and impact. Dermatology Times.