NCT02812719

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

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

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Melasma

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2018-07-01
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2016-06-24
• Last updated: 2018-06-26

Regulatory

• FDA-regulated drug study