NCT01976286

Brief Summary

The purpose of this study is to find out the safety and effectiveness of Glycolic Acid Chemical Peels compared to Salicylic Acid Chemical Peels for the treatment of melasma.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

October 15, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

10.9 years

First QC Date

October 15, 2013

Last Update Submit

January 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 16

    The primary outcome was a blinded rating of the treatment area (Salicylic Acid Peels Versus Glycolic Acid Peels) with the best overall cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 16).

    1 hour at baseline and week 16

Study Arms (2)

Salicylic Acid Peels

ACTIVE COMPARATOR

Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.

Other: Salicylic Acid Peels

Glycolic Acid Peels

ACTIVE COMPARATOR

Salicylic Acid and Glycolic Acid Chemical Peels are skin treatments used to correct uneven texture and color by removing dead cells from the skin's top layer.

Other: Glycolic Acid Peels

Interventions

Salicylic Acid Peels
Glycolic Acid Peels

Eligibility Criteria

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

You may qualify if:

  • Subjects aged 18 years or older
  • Subjects with at least a 2 x 2 cm patch of melasma on each side of the face (forehead or cheek)
  • Subjects in general good health
  • Subjects must be willing and able to understand and provide informed consent for the use of their tissue and communicate with the investigator
  • Subjects must be willing to not apply other treatment options for melasma during the course of the study

You may not qualify if:

  • Subjects under 18 years of age
  • Subjects who are pregnant and/or lactating
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects diagnosed with mental illness
  • Subjects who have concurrent active uncontrolled disease to facial area (i.e uncontrolled acne)
  • Subjects who have had a chemical peel in the past 3 months
  • Subjects who have used a prescribed retinoid in the past 3 months
  • Subjects with a bleeding disorder
  • Subjects with a history of abnormal wound healing
  • Subjects with a history of abnormal scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

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

October 15, 2013

First Posted

November 5, 2013

Study Start

January 1, 2015

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations