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Azelex (Azelaic Acid Topical) - Summary



AZELEX® (azelaic acid cream) 20% contains azelaic acid, a naturally occurring saturated dicarboxylic acid.

AZELEX® Cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

See all Azelex indications & dosage >>


Media Articles Related to Azelex (Azelaic Acid Topical)

What's New in Acne and Rosacea
Source: Medscape Dermatology Headlines [2016.04.29]
Dr Hillary Baldwin summarizes the latest acne and rosacea news from the 2016 American Academy of Dermatology meeting.
Medscape Dermatology

Pregnancy Prevention Program in Acne Drug Users Ineffective
Source: Medscape Dermatology Headlines [2016.04.26]
Results suggest one or two children are born each year with birth defects related to isotretinoin and subpar contraceptive use.
Medscape Medical News

Contraception Safety Program for Acne Drug Failing in Canada
Source: MedicineNet Acne Specialty [2016.04.26]
Title: Contraception Safety Program for Acne Drug Failing in Canada
Category: Health News
Created: 4/25/2016 12:00:00 AM
Last Editorial Review: 4/26/2016 12:00:00 AM

Pregnancy guidelines for harmful acne drug not adhered to by many women
Source: Pregnancy / Obstetrics News From Medical News Today [2016.04.25]
A new study suggests around 30-50 percent of women who use the acne drug isotretinoin do not adhere to current pregnancy prevention guidelines.

Acne Drug: FDA Advisors Recommend OTC Adapalene
Source: MedPage Today Dermatology [2016.04.15]
(MedPage Today) -- Panel votes 16-0 that the drug is safe for use without a prescription.

more news >>

Published Studies Related to Azelex (Azelaic Acid Topical)

Combination of azelaic acid 5% and clindamycin 2% for the treatment of acne vulgaris. [2011]
vulgaris... CONCLUSION: The profound reduction in lesion count and ASI by

Efficacy of 15% azelaic acid in psoriasis vulgaris: a randomized, controlled clinical trial. [2010.08]
BACKGROUND: Psoriasis is a common disorder affecting 1-3 percent of the general global population...

Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. [2010.06]
Rosacea is a leading reason why people seek the care of a dermatologist, accounting for nearly 7 million office visits annually. Pharmacologic treatments include both topical and oral medications, which are increasingly being used in combination, especially at the outset of therapy... These findings warrant further investigation in a sufficiently powered study.

Combination of azelaic acid 5% and erythromycin 2% in the treatment of acne vulgaris. [2010.05]
INTRODUCTION: Acne vulgaris is a common problem, particularly among adolescents, which is usually resistant to monotherapy. We evaluated the efficacy and safety of a combination of azelaic acid (AA) 5% and erythromycin 2% gel (AzE) compared with AA 20% or erythromycin 2% gels in facial acne vulgaris... CONCLUSIONS: The combination of AA 5% and erythromycin 2% produced more potent therapeutic effects in comparison with erythromycin 2% or AA 20% alone, and with fewer side effects.

A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy. [2009.07]
This two-phase, multicenter study was undertaken to examine the safety and efficacy of combination therapy with oral doxycycline and topical azelaic acid (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the effect of subsequent maintenance monotherapy with AzA 15% gel alone...

more studies >>

Clinical Trials Related to Azelex (Azelaic Acid Topical)

Study for Long-term Treatment of Acne Vulgaris With Skinoren Versus Differin [Completed]
The purpose of this study is to assess the effect of Skinoren« 15% gel compared to no therapy on the maintenance of clinical therapy success in subjects with mild to moderate acne vulgaris previously treated for 3 months by a monotherapy of this substance and to assess the effect of Skinoren« 15% gel, compared to Differin« 0. 1% gel on the efficacy and safety during a 9-month long-term treatment period.

Azelaic Acid Versus Hydroquinone in Melasma [Recruiting]

Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea [Completed]

Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study [Active, not recruiting]
The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0. 33% Gel could be more effective than Brimonidine 0. 33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma [Recruiting]
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical treatment with azelaic acid cream in female patients with melasma.

more trials >>


Based on a total of 2 ratings/reviews, Azelex has an overall score of 5.50. The effectiveness score is 5 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.

Azelex review by 62 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
Treatment Info
Condition / reason:   acne
Dosage & duration:   twice daily application to skin (dosage frequency: twice daily) for the period of 2 years
Other conditions:   HTN
Other drugs taken:   Hydrochlorothiazide
Reported Results
Benefits:   Significant reduction in acne lesions. The size, frequency and severity of the lesions was reduced in the first week of use.
Side effects:   Drying, flaking, peeling of the skin where the cream was applied. These side effects were reduced by using the product only at night time.
Comments:   I noticed reduction in frequency and severity of acne lesions during the first week of use. Application was done on clean dry skin and a non-oily moisturizer was applied after the product had absorbed. Sunscreen was applied for daytime use.


Azelex review by 44 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Acne
Dosage & duration:   20% Cream (dosage frequency: once daily) for the period of 2 weeks
Other conditions:   hyperpigmentation
Other drugs taken:   Synthroid and Cytomel
Reported Results
Benefits:   I was not able to use the cream long enough because of the side effects.
Side effects:   The cream itched and burned severely to the point of being nearly intolerable for the first week. The burning subsided in the second week, but not to the point of being usable on a daily basis.
Comments:   Application of cream nightly 15 minutes after washing. Product information advised waiting, but it still burned and itched when applying it after waiting. it had no real visible effect during the time I used it. I gave it a 2 instead of 1 because I felt a very subjective glimmer of potential improvement at the end of the period, but not enough to overcome the pain.

See all Azelex reviews / ratings >>

Page last updated: 2016-04-29

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