Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: A safe and efficacious 12-month treatment for melasma

Helen Mary Torok, Terry Jones, Phoebe Rich, Stacy Smith, Eduardo Tschen

Research output: Contribution to journalArticle

72 Citations (Scopus)

Abstract

This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma® Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76%) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile: only 3 patients (1%) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57%) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90% of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.

Original languageEnglish (US)
Pages (from-to)57-62
Number of pages6
JournalCutis
Volume75
Issue number1
StatePublished - Jan 1 2005
Externally publishedYes

Fingerprint

Fluocinolone Acetonide
Melanosis
Tretinoin
Therapeutics
Safety
Telangiectasis
Skin
Atrophy
hydroquinone
Physicians

ASJC Scopus subject areas

  • Dermatology

Cite this

Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01% : A safe and efficacious 12-month treatment for melasma. / Torok, Helen Mary; Jones, Terry; Rich, Phoebe; Smith, Stacy; Tschen, Eduardo.

In: Cutis, Vol. 75, No. 1, 01.01.2005, p. 57-62.

Research output: Contribution to journalArticle

Torok, Helen Mary ; Jones, Terry ; Rich, Phoebe ; Smith, Stacy ; Tschen, Eduardo. / Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01% : A safe and efficacious 12-month treatment for melasma. In: Cutis. 2005 ; Vol. 75, No. 1. pp. 57-62.
@article{ba2b4c3bb4184d91849a535354c43ef3,
title = "Hydroquinone 4{\%}, tretinoin 0.05{\%}, fluocinolone acetonide 0.01{\%}: A safe and efficacious 12-month treatment for melasma",
abstract = "This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01{\%}, hydroquinone 4{\%}, tretinoin 0.05{\%} (Tri-Luma{\circledR} Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76{\%}) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile: only 3 patients (1{\%}) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57{\%}) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90{\%} of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.",
author = "Torok, {Helen Mary} and Terry Jones and Phoebe Rich and Stacy Smith and Eduardo Tschen",
year = "2005",
month = "1",
day = "1",
language = "English (US)",
volume = "75",
pages = "57--62",
journal = "Cutis",
issn = "0011-4162",
publisher = "Quadrant Healthcom Inc.",
number = "1",

}

TY - JOUR

T1 - Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%

T2 - A safe and efficacious 12-month treatment for melasma

AU - Torok, Helen Mary

AU - Jones, Terry

AU - Rich, Phoebe

AU - Smith, Stacy

AU - Tschen, Eduardo

PY - 2005/1/1

Y1 - 2005/1/1

N2 - This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma® Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76%) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile: only 3 patients (1%) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57%) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90% of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.

AB - This article describes a long-term, multicenter, open-label, 12-month study of once-daily fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% (Tri-Luma® Cream, hereinafter called TC [triple combination]) application in the treatment of melasma. A total of 228 patients with facial melasma were enrolled and treated; 173 patients (76%) completed the study. Most patients had 1 to 2 courses of treatment lasting approximately 6 months in total. TC cream showed a favorable safety profile: only 3 patients (1%) withdrew from the study due to treatment-related adverse events (AEs). A total of 129 patients (57%) experienced at least one treatment-related AE. Most AEs were expected application-site reactions that were mild and transient in nature and did not require remedial therapy. There were no cases of skin atrophy or skin thinning and only 6 cases of telangiectasia (5 mild and 1 moderate), most of which had improved by the end of the study. Results of the efficacy assessments were positive, with both the patient and the physician assessing melasma to be either completely or nearly cleared by the end of the study in more than 90% of cases. In this study, a once-daily application of TC cream over an extended period of 12 months showed no notable safety concerns and offered an effective treatment for melasma.

UR - http://www.scopus.com/inward/record.url?scp=13544262499&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=13544262499&partnerID=8YFLogxK

M3 - Article

C2 - 15732437

AN - SCOPUS:13544262499

VL - 75

SP - 57

EP - 62

JO - Cutis

JF - Cutis

SN - 0011-4162

IS - 1

ER -