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

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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Recruitment Status : Withdrawn (Study did not receive funding and will not be implemented.)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

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.

Condition or disease Intervention/treatment Phase
Melasma Drug: Glycolic acid peel alone Drug: Glycolic and salicylic acid peel Early Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Adverse events assessment [ Time Frame: Week 7-8 (1-2 weeks following 4th peel) ]
    Patient questionnaire to assess for any adverse events encountered



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications:
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02812719     History of Changes
Other Study ID Numbers: H-33976
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Salicylic Acid
Glycolic acid
Salicylates
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action