Azelaic Acid Versus Hydroquinone in Melasma

Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00927771

Enrollment

Registered

2009-06-25

Start date

2009-06-30

Completion date

2010-12-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanosis

Keywords

melanosis, melasma, azelaic acid, hydroquinone

Brief summary

The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Detailed description

Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.

Interventions

DRUGazelaic acid gel

azelaic acid 15% gel twice a day for 6 months

DRUGhydroquinone cream

hydroquinone 4% cream twice a day for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* must have stable moderate-severe epidermal or mixed melasma involving the face * all races * males and females * persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months

Exclusion criteria

* if the person has only dermal melasma * pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant * a known allergy or sensitivity ot azelaic acid or hydroquinone * the use of photosensitizing medications (ex. tetracycline) within 3 months of the study. * starting or stopping hormonal medication within 3 months * chemical peels, microdermabrasion, or laser treatment within 6 months * worsening or improving melasma

Design outcomes

Primary

Measure	Time frame
Improvement of melasma	6 months

Countries

United States

Contacts

Primary ContactTracy Brooks

clinicalresearch@callenderskin.com301.249.0970

Backup ContactCherie Young, MD