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

NCT ID: NCT02812719

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-02-28

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Glycolic acid peel alone

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Glycolic and salicylic acid peel

Intervention Type: DRUG

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.

Interventions

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 Type: 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.

Intervention Type: DRUG

Other Intervention Names

Single acid skin peel; Combination acid skin peel

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Reference Type: BACKGROUND

PMID: 16781293 (View on PubMed)

Berson DS, Cohen JL, Rendon MI, Roberts WE, Starker I, Wang B. Clinical role and application of superficial chemical peels in today's practice. J Drugs Dermatol. 2009 Sep;8(9):803-11.

Reference Type: BACKGROUND

PMID: 19746672 (View on PubMed)

Kodali S, Guevara IL, Carrigan CR, Daulat S, Blanco G, Boker A, Hynan LS, Pandya AG. A prospective, randomized, split-face, controlled trial of salicylic acid peels in the treatment of melasma in Latin American women. J Am Acad Dermatol. 2010 Dec;63(6):1030-5. doi: 10.1016/j.jaad.2009.12.027.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Grimes PE. The safety and efficacy of salicylic acid chemical peels in darker racial-ethnic groups. Dermatol Surg. 1999 Jan;25(1):18-22. doi: 10.1046/j.1524-4725.1999.08145.x.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 14725662 (View on PubMed)

Other Identifiers

H-33976

Identifier Type: -

Identifier Source: org_study_id