Study of Acid Peel and Laser for the Treatment of Melasma | NCT00467233

Studies
Study of Acid Peel and Laser for the Treatment of Melasma

NCT00467233

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Melasma

Interventions

Laser Treatment
Acid Peel

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Apr 26, 2007

First Submission Date that Met QC Criteria

Apr 26, 2007

First Posted Date

Apr 30, 2007Estimated

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

Nov 30, 2021

Last Update Posted Date

Dec 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Northwestern UniversityOTHER

Collaborators

Not provided

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 objective of this study is to evaluate laser treatment and acid peel for the treatment of melasma.

Detailed Description

The purpose of this study is to evaluate the safety and efficacy of laser treatment and acid peel for the treatment of melasma.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Laser Treatment	Procedure: Laser Treatment
2	Experimental	Acid peel	Procedure: Acid Peel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Treatment	Procedure	Laser treatment to half of the face at each study visit	1

Measure	Description	Time Frame
MASI		20 weeks

Measure	Description	Time Frame
Safety		20 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of melasma lesion measuring at least 4 square centimeters.
Age 18-75 years.
Good health.
Willingness and ability to understand and provide informed consent for participation in the study.
Ability to communicate with the investigator.
Must be willing to forgo other treatment options for melasma during the course of the study.

Exclusion Criteria:

Inability to understand the protocol or to give informed consent.
Mental illness.
Under 18 years of age and over 75 years of age.
Laser treatment in the last 6 months before enrollment.
Isotretinoin within the past year.
Lidocaine allergy.
History of herpes simplex viral infection.
Concurrent active disease to facial area (i.e acne).
Bleeding disorder.
History of abnormal wound healing.
History of abnormal scarring.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Feinberg School of Medicine, Department of Dermatology		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D008548	Melanosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided