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Azelaic acid

Generic Name
Azelaic acid
Brand Names
Azelex, Finacea
Drug Type
Small Molecule
Chemical Formula
C9H16O4
CAS Number
123-99-9
Unique Ingredient Identifier
F2VW3D43YT
Background

Azelaic acid is a saturated dicarboxylic acid found naturally in wheat, rye, and barley. It is also produced by Malassezia furfur, also known as Pityrosporum ovale, which is a species of fungus that is normally found on human skin. Azelaic acid is effective against a number of skin conditions, such as mild to moderate acne, when applied topically in a cream formulation of 20%. It works in part by stopping the growth of skin bacteria that cause acne, and by keeping skin pores clear. Azelaic acid's antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.

Indication

For the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Associated Conditions
Acne Vulgaris, Inflammatory lesions caused by rosacea, Susceptible Bacterial Infections
Associated Therapies
Nutritional supplementation

Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation

Phase 1
Not yet recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2025-05-11
Last Posted Date
2025-05-11
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
33
Registration Number
NCT06966388
Locations
🇺🇸

Virginia Commonwealth University, Richmond, Virginia, United States

Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)

Early Phase 1
Not yet recruiting
Conditions
Central Centrifugal Cicatricial Alopecia
Interventions
Other: usual medication for CCCA
First Posted Date
2022-06-13
Last Posted Date
2024-08-27
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
15
Registration Number
NCT05416333
Locations
🇺🇸

Wake Forest University Health Scieces, Winston-Salem, North Carolina, United States

Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea

Phase 4
Completed
Conditions
Rosacea
Interventions
First Posted Date
2021-08-20
Last Posted Date
2021-08-20
Lead Sponsor
Dermatology Specialists Research
Target Recruit Count
60
Registration Number
NCT05014906
Locations
🇺🇸

Dermatology Specialists, Louisville, Kentucky, United States

To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

Phase 1
Completed
Conditions
Rosacea
Interventions
Drug: Azelaic acid foam 15%
Drug: Vehicle of the test product
First Posted Date
2018-09-28
Last Posted Date
2019-03-19
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
1116
Registration Number
NCT03689010
Locations
🇺🇸

Catawba Research, LLC, Charlotte, North Carolina, United States

A Study to Evaluate Safety and Equivalence of Generic Azelaic Acid Foam and Finacea® Foam in Participants With Rosacea

Phase 3
Completed
Conditions
Rosacea
Interventions
Drug: Generic Azelaic Acid Foam
Drug: Vehicle Foam
Other: Cleanser
Other: Sunscreen
Other: Towel
Other: Moisturizing Lotion
First Posted Date
2017-09-19
Last Posted Date
2019-07-31
Lead Sponsor
Actavis Inc.
Target Recruit Count
924
Registration Number
NCT03287791
Locations
🇺🇸

Investigative Site 8, High Point, North Carolina, United States

🇺🇸

Investigative Site 5, Norfolk, Virginia, United States

🇺🇸

Investigative Site 21, Philadelphia, Pennsylvania, United States

and more 23 locations

To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel

Phase 1
Completed
Conditions
Rosacea
Interventions
Drug: Placebo
Drug: Azelaic Acid 15% topical gel
First Posted Date
2017-03-29
Last Posted Date
2024-04-10
Lead Sponsor
Taro Pharmaceuticals USA
Target Recruit Count
1000
Registration Number
NCT03094403

Azelaic Acid on Demodex Counts in Rosacea

Phase 2
Completed
Conditions
Rosacea
Interventions
First Posted Date
2017-01-30
Last Posted Date
2018-09-07
Lead Sponsor
Wake Forest University
Target Recruit Count
20
Registration Number
NCT03035955
Locations
🇺🇸

Wake Forest University Health Sciences Department of Dermatology, Winston-Salem, North Carolina, United States

Preferences & Treatment Satisfaction Drivers in Rosacea Patients

First Posted Date
2015-11-11
Last Posted Date
2020-04-01
Lead Sponsor
LEO Pharma
Target Recruit Count
206
Registration Number
NCT02602470

A Study to Evaluate the Safety and Clinical Study of Azelaic Acid Gel 15% in Patients With Moderate Facial Rosacea

Phase 3
Completed
Conditions
Rosacea
Interventions
First Posted Date
2014-04-23
Last Posted Date
2020-06-02
Lead Sponsor
Actavis Inc.
Target Recruit Count
1009
Registration Number
NCT02120924
Locations
🇺🇸

Site 17, Glenn Dale, Maryland, United States

🇺🇸

Site 6, Bay City, Michigan, United States

🇺🇸

Site 24, Fremont, California, United States

and more 27 locations

Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris

Phase 4
Completed
Conditions
Acne Vulgaris
Interventions
First Posted Date
2014-02-10
Last Posted Date
2017-08-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
222
Registration Number
NCT02058628
Locations
🇩🇪

GSK Investigational Site, Berlin, Germany

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