Azelaic Acid Versus Hydroquinone in Melasma | NCT00927771

Studies
Azelaic Acid Versus Hydroquinone in Melasma

NCT00927771

Sponsor

Callender Center for Clinical Research

Status

Unknown status

Last Update Posted

Jun 25, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Melanosis

Interventions

azelaic acid gel
hydroquinone cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 23, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2009

Last Update Posted Date

Jun 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azelaic Acid	Experimental		Drug: azelaic acid gel
Hydroquinone	Active Comparator		Drug: hydroquinone cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
azelaic acid gel	Drug	azelaic acid 15% gel twice a day for 6 months	Azelaic Acid

Measure	Description	Time Frame
Improvement of melasma		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tracy Brooks	Contact	301.249.0970		clinicalresearch@callenderskin.com
Cherie Young, MD	Contact	301.249.0970		clinicalresearch@callenderskin.com

Overall Officials

Name	Affiliation	Role
Valerie D Callender, MD	Howard University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Callender Center for Clinical Research	Recruiting	Mitchellville	Maryland	20721	United States

References Module

Citations

Not provided

ID	Term
D017495	Hyperpigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D006873	Hydroquinones
C031927	hydroquinone

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic