Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Melasma With Glycolic Acid-Salicylic Acid Peel Versus Glycolic Acid Peel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812719
Recruitment Status : Withdrawn (Study did not receive funding and will not be implemented.)
First Posted : June 24, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center

Tracking Information
First Submitted Date  ICMJE October 28, 2015
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date June 26, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Change in pigmentation [ Time Frame: Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
Change in pigmentation using a colorimeter
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Change in pigmentation using a colorimeter [ Time Frame: Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • Change in pigmentation score [ Time Frame: Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
    Change in pigmentation using the Melasma Area and Severity Index (MASI)
  • Improvement of melasma [ Time Frame: Week 0 and Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
    Improvement of melasma based on Patient and Physician Global assessment
  • Adverse events assessment [ Time Frame: Week 7-8 (1-2 weeks following 4th peel) ]
    Patient questionnaire to assess for any adverse events encountered
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Change in pigmentation using the Melasma Area and Severity Index (MASI) score [ Time Frame: Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
  • Improvement of melasma based on Patient and Physician Global assessment [ Time Frame: Week 0 and Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel) ]
  • Patient questionnaire to assess for any adverse events encountered [ Time Frame: Week 7-8 (1-2 weeks following 4th peel) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Melasma With Glycolic Acid-Salicylic Acid Peel Versus Glycolic Acid Peel
Official Title  ICMJE Comparing the Efficacy and Safety of Combined Glycolic Acid and Salicylic Acid Peel Versus Glycolic Acid Peel Alone in the Treatment of Melasma: A Split Face Study
Brief Summary The aim of this pilot study is to conduct a controlled comparison of the efficacy and safety of a combination peel (glycolic acid and salicylic acid) as compared to glycolic acid peel alone in the treatment of melasma. Our primary outcome is objective improvement in pigmentation as evaluated using a colorimeter. Our secondary outcomes are subjective improvement using the Melasma Area and Severity Index (MASI) and Patient and Physician Global assessment, as well as assessment of treatment tolerability and patient satisfaction.
Detailed Description

Melasma is an acquired form of hyperpigmentation that is seen most commonly on the face, characterized by symmetrically distributed brown patches of variable darkness. The cosmetically unattractive nature of this disorder has been shown to negatively affect a patient's quality of life. Unfortunately, the treatment of melasma is challenging and often disappointing. Treatment includes a combination approach with strict sun protection, cosmetic camouflage, topical lightening agents, laser therapy, and chemical peels.

Today, the investigators define chemical peeling as the application of chemical exfoliating agents to the skin, which results in destruction of one or more parts of the epidermis and/or dermis with subsequent regrowth of these layers. Chemical peels are divided into superficial (light), medium, and deep; with superficial peels being the focus of this study. Superficial peels penetrate into the epidermis only, and are a safe, widely available and well-tolerated treatment modality. These peeling agents include glycolic acid, lactic acid, mandelic acid, salicylic acid and trichloroacetic acid, each with unique properties. For instance, alpha-hydroxy acids, such as glycolic acid, are known to be hydrophilic, whereas salicylic acid is lipophilic and anti-inflammatory.

As each peeling agent has unique properties, it can be hypothesized that the combined use of these agents may result in better clinical outcomes than the use of an agent alone. Prior studies have demonstrated that the combined use of these peels are safe and effective in improving a variety of skin conditions including acne scars, hyperpigmentation, and infraorbital dark circles. Overall however, studies on the combined use of these chemical peels in the treatment of melasma are lacking.

Therefore, the aim of this pilot study is to conduct a controlled comparison of the efficacy and safety of a combination peel (glycolic acid and salicylic acid) as compared to glycolic acid peel alone in the treatment of melasma.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melasma
Intervention  ICMJE
  • Drug: Glycolic acid peel alone

    One of two sides of the face will be randomly treated with glycolic acid peel 35% alone.

    This treatment will be administered at visit 1 (but to entire face) and 3 subsequent visits (to one randomly selected side of the face), for a total of 4 treatments at 2 week intervals

    Other Name: Single acid skin peel
  • Drug: Glycolic and salicylic acid peel

    The other randomly chosen side of the face will be treated with glycolic acid peel 35% followed by salicylic acid peel 20%, as a combination treatment.

    This treatment will be administered at visits 2, 3 and 4 (to one randomly selected side of the face), for a total of 3 treatments at 2 week intervals.

    Other Name: Combination acid skin peel
Study Arms  ICMJE
  • Active Comparator: Glycolic acid peel alone

    One of two sides of the face will be randomly treated with glycolic acid peel 35% alone.

    This treatment will be administered at visit 1 (but to entire face) and 3 subsequent visits (to one randomly selected side of the face), for a total of 4 treatments at 2 week intervals

    Intervention: Drug: Glycolic acid peel alone
  • Experimental: Glycolic and salicylic acid peel

    The other randomly chosen side of the face will be treated with glycolic acid peel 35% followed by salicylic acid peel 20%, as a combination treatment.

    This treatment will be administered at visits 2, 3 and 4 (to one randomly selected side of the face), for a total of 3 treatments at 2 week intervals.

    Intervention: Drug: Glycolic and salicylic acid peel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
30
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female and males aged 18 or older
  • Subjects with melasma on both sides of the face (forehead or cheek).
  • Subjects in general good health
  • Female of childbearing age will be on a reliable form of contraception during the course of treatment other than oral contraceptive pills or hormonal intrauterine device.
  • Subjects must be willing to sign consent, answer questionnaires, comply with all clinical visits, and use sunscreen and sun-protection.
  • Subjects must be willing to not apply other treatment options for melasma during the course of the study

Exclusion Criteria:

  • Subjects suffering from other pigmentation disorders.
  • Subjects with known allergy to any components of the peels
  • Subjects who have active uncontrolled disease to facial area (i.e acne).
  • Pregnant women, nursing mothers.
  • Subjects with history of abnormal scaring
  • Subjects who cannot communicate with investigators or who are unlikely to cooperate.
  • Subjects in a situation in which in the opinion of the investigators, may interfere with optimal participation in the study.
  • Subjects who have used chemical peels, microdermabrasion or facial laser treatments in the past 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812719
Other Study ID Numbers  ICMJE H-33976
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boston Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP