NCT00467233

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2.1 years

First QC Date

April 26, 2007

Last Update Submit

November 30, 2021

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • MASI

    20 weeks

Secondary Outcomes (1)

  • Safety

    20 weeks

Study Arms (2)

1

EXPERIMENTAL

Laser Treatment

Procedure: Laser Treatment

2

EXPERIMENTAL

Acid peel

Procedure: Acid Peel

Interventions

Laser TreatmentPROCEDURE

Laser treatment to half of the face at each study visit

1
Acid PeelPROCEDURE

Acid peel to half of the face at each study visit

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanosis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 30, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

US(1)