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

NCT02812719 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: H-33976
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Change in pigmentation

  Change in pigmentation using a colorimeter

  Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel)

Secondary Outcomes (3)

• Change in pigmentation score

  Week 0, Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel)

• Improvement of melasma

  Week 0 and Week 7-8 (1-2 weeks following 4th peel), and Week 18 (12 weeks following 4th peel)

• Adverse events assessment

  Week 7-8 (1-2 weeks following 4th peel)

Study Arms (2)

Glycolic acid peel alone

ACTIVE COMPARATOR

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

Glycolic and salicylic acid peel

EXPERIMENTAL

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

Interventions

Glycolic acid peel alone 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

Also known as: Single acid skin peel

Glycolic acid peel alone

Glycolic and salicylic acid peel 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.

Also known as: Combination acid skin peel

Glycolic and salicylic acid peel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Related Publications (7)

• Dominguez AR, Balkrishnan R, Ellzey AR, Pandya AG. Melasma in Latina patients: cross-cultural adaptation and validation of a quality-of-life questionnaire in Spanish language. J Am Acad Dermatol. 2006 Jul;55(1):59-66. doi: 10.1016/j.jaad.2006.01.049. Epub 2006 May 2.

  PMID: 16781293 BACKGROUND

• 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.

  PMID: 19746672 BACKGROUND

• 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.

  PMID: 20889235 BACKGROUND

• Sarkar R, Kaur C, Bhalla M, Kanwar AJ. The combination of glycolic acid peels with a topical regimen in the treatment of melasma in dark-skinned patients: a comparative study. Dermatol Surg. 2002 Sep;28(9):828-32; discussion 832. doi: 10.1046/j.1524-4725.2002.02034.x.

  PMID: 12269877 BACKGROUND

• Soliman MM, Ramadan SA, Bassiouny DA, Abdelmalek M. Combined trichloroacetic acid peel and topical ascorbic acid versus trichloroacetic acid peel alone in the treatment of melasma: a comparative study. J Cosmet Dermatol. 2007 Jun;6(2):89-94. doi: 10.1111/j.1473-2165.2007.00302.x.

  PMID: 17524124 BACKGROUND

• 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.

  PMID: 9935087 BACKGROUND

• Lee HS, Kim IH. Salicylic acid peels for the treatment of acne vulgaris in Asian patients. Dermatol Surg. 2003 Dec;29(12):1196-9; discussion 1199. doi: 10.1111/j.1524-4725.2003.29384.x.

  PMID: 14725662 BACKGROUND

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: June 24, 2016
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share