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Azelaic Acid 15%

Phase 3

Acne Vulgaris | Small molecule | Dermatology |Bayer AG|Last Updated: Jun 9, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment879

FDA Designations

No designations recorded

Clinical trial landscape

Azelaic Acid 15% · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00031096Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate AcneAcne Vulgaris
COMPLETED879 Analytics
PHASE3COMPLETED
Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
Acne Vulgaris
NCT00031096879
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Study Endpoints

Primary Endpoints

The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne
12 weeks
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
Measurement of parameters during the course of treatment (six weeks)

Secondary Endpoints

Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
12 weeks
Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
12 weeks
Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms
Measurement of parameters during the course of treatment (six weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -
1ACTIVE_COMPARATORazelaic acid 15%
2PLACEBO_COMPARATORInactive 15% gel base

Interventions

NameTypeDescription
Azelaic Acid Gel 15% (Finacea, BAY39-6251)DRUGAzelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
Vehicle gel (SH H 655 PBA)DRUGVehicle gel (SH H 655 PBA) applied topically two times per day.
Azelaic Acid 15% GelDRUG15% gel, topically applied daily for six weeks
Inactive 15% gel baseDRUGplacebo, topically applied daily for six weeks
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: To be included in the study you MUST have: * Predominantly facial localization of acne * Mild to moderate acne vulgaris characterized by the presence of both inflammatory papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity suitable for treatment wi...

Countries:United StatesGermany
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Frequently asked questions about Azelaic Acid 15%

What is Azelaic Acid 15% used for?

Azelaic Acid 15% is a small molecule dermatology drug being developed by Bayer AG for the treatment of acne vulgaris and seborrheic dermatitis on the face. It is currently in clinical development and is not approved by the FDA.

What does Azelaic Acid 15% target?

Azelaic Acid 15% is a small molecule, but its specific molecular target is not disclosed. It is being studied for its efficacy and safety in treating acne vulgaris and seborrheic dermatitis on the face.

Who makes Azelaic Acid 15%?

Azelaic Acid 15% is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is in Phase 3 clinical development for dermatology indications.

What phase is Azelaic Acid 15% in?

Azelaic Acid 15% is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials are ongoing or completed to evaluate its safety and efficacy.

What clinical trials is Azelaic Acid 15% in?

Azelaic Acid 15% has been studied in two completed trials. NCT00031096 was a Phase 3 trial in 879 patients with mild to moderate acne vulgaris. NCT00408330 was a Phase 2 trial in 48 patients with seborrheic dermatitis on the face.