Investigator-Blinded, Single-Center Study to Evaluate the Efficacy and Tolerability of a 4% Hydroquinone Skin Care System Plus 0.02% Tretinoin Cream in Mild-to-Moderate Melasma and Photodamage

April 2016 | Volume 15 | Issue 4 | Original Article | 466 | Copyright © 2016

Marta Rendon MD FAADa and Laurence Dryer PhDb

aThe Rendon Center for Dermatology & Aesthetic Medicine and Skin Care Research Inc, Boca Raton, FL
bValeant Pharmaceuticals North America LLC, Irvine CA

Abstract

OBJECTIVE: To evaluate the treatment of mild-to-moderate epidermal melasma and photodamage using a 4% hydroquinone skin care system plus tretinoin 0.02% cream.
METHODS: Single-center, investigator-blinded study in 39 adult females with mild-to-moderate epidermal melasma, mild-to-marked pigmentation intensity, and Fitzpatrick skin type III to VI treated for 24 weeks. Improvements in melasma severity, pigmentation intensity, photodamage, and patient satisfaction were assessed at weeks 4, 8, 12, 18, and 24. Cutaneous tolerability was assessed by investigator (erythema, dryness, peeling) and patients (burning and stinging). Adverse events (AEs) were monitored throughout.
RESULTS: Melasma severity, pigmentation intensity, and melasma area and severity index (MASI) scores relative to baseline were all significantly reduced from week 4 onward (P<.001). In addition, signs of facial photodamage were significantly improved. At week 24, 87.9% of patients were “satisfied” or “very satisfied” with the overall treatment effectiveness and Quality of Life (QoL) was much improved. No patient discontinued due to lack of efficacy or treatment-related AEs. One patient (2.8%) reported severe cutaneous intolerability (erythema at week 4).
CONCLUSION: Treating mild-to-moderate melasma using a 4% hydroquinone skin care system plus 0.02% tretinoin cream can significantly reduce the severity and intensity of melasma and associated pigmentation, and improve signs of photodamage within four weeks. Treatment was generally well tolerated and associated with high levels of patient satisfaction.

J Drugs Dermatol. 2016;15(4):466-475.

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INTRODUCTION

Hyperpigmentation disorders, including melasma, are common, particularly among people with darker skin.1-6 Melasma, a progressive form of hyperpigmentation, occurs most commonly in women (more than 90% of cases7), and especially those living in areas of intense sunlight.8-10

Melasma is a dysfunction of the pigmentary system characterized by patches of light brown or gray-brown facial hypermelanosis on sun exposed areas of the face, particularly the forehead, cheeks, upper lip, and chin. Epidermal melasma is the most common presentation (occurring in 70% of cases) and is limited primarily to the basal and suprabasal epidermis, and appears as a brown discoloration. Dermal melasma is less common (occurring in 10% of cases), less responsive to treatment and clinically presents with a blue-gray pigmentation. Approximately 20% of patients will present with mixed melasma.11 Patients with melasma often also exhibit symptoms of facial photodamage such as mottled hyperpigmentation, lentigines, fine and coarse wrinkling, tactile roughness, and elastosis.

Often the psychosocial impact of the disease can cause great distress leading to decreased socializing, diminished self-esteem, and lower productivity.12-14 With treatment, studies have shown that a patient’s reported Quality of Life (QoL) improves.15

Hydroquinone-containing bleaching creams have been used for many years in the treatment of mild-to-moderate melasma. Hydroquinone produces a reversible depigmentation by inhibiting the oxidation of tyrosine and phenol oxidases and suppressing other melanocyte metabolic processes such as pigment production.16,17 Topical tretinoin monotherapy has also been used extensively.18,19 Retinoids such as tretinoin help to eliminate the dispersed pigment in the keratinocytes by accelerating epidermal proliferation thereby lightening the areas of hyperpigmentation.20 Retinoids also improve photodamage.

One of the drawbacks of monotherapy, whether hydroquinone or a retinoid, is the prolonged treatment time required before meaningful results are evident.21 For example, it typically takes at least

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