Abstract
Melasma is a common disorder of hyperpigmentation and generally involves areas of the face and neck. Hyperpigmentation is especially prevalent in darker complected patients and is often difficult to treat. Hydroquinone, tretinoin, and topical corticosteroids are well established monotherapeutic agents for treating melasma and hyperpigmentation; however, a stable, once-daily formulation triple combination cream containing 0.05% tretinoin, 4.0% hydroquinone, and 0.01% fluocinolone acetonide (Tri-Luma®) represents the only commercially available combination of all three agents. This product is approved by the US FDA for the treatment of facial melasma. A number of publications have described the safety and efficacy of triple combination cream in over 2000 patients with melasma, some of whom were treated for >12 months.
In the initial 8-week study, 29% of patients experienced complete clearing of melasma by week 8, and 77% were clear or almost clear by week 8. Similarly, good results were seen in the two long-term studies, with the clear/mild rate ranging from 78% to 84% of patients at month 6 and from 81% to 94% of patients at month 12. Adverse events were almost always mild in severity and typically occurred only at the application site. The primary concern for most physicians using corticosteroid-containing products on the face is skin atrophy. However, only two cases of skin atrophy were reported across the three published studies.
Overall, the results of these extensive studies indicate that triple combination cream is efficacious in treating melasma and exhibits a safe profile with low potential for adverse events.
Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
References
Grimes PE. Melasma: etiologic and therapeutic considerations. Arch Dermatol. 1995; 131 (12): 1453–7
Sanchez NP, Pathak MA, Sato S, et al. Melasma: a clinical, light microscopic, ultrastructural, and immunofluorescence study. J Am Acad Dermatol. 1981; 4 (6): 698–710
Kauh YC, Zachian TF. Melasma. Adv Exp Med Biol. 1999; 455: 491–9
Pathak MA, Fitzpatrick TB, Kraus EW. Usefulness of retinoic acid in the treatment of melasma. J Am Acad Dermatol. 1986; 15 (4 Pt 2): 894–9
Menter A. Rationale for the use of topical corticosteroids in melasma. J Drugs Dermatol. 2004; 3 (2): 169–74
American Academy of Dermatology. Dermatologists dispatch dark side of melasma [online]. Available from URL: http://www.aad.org/public/News/NewsReleases/Press+Release+Archives/Skin+Conditions/Melasma.htm [Accessed 2005 Dec 22]
Taylor SC. Epidemiology of skin diseases in people of color. Cutis. 2003; 71 (4): 271–5
Balkrishnan R, McMichael AJ, Camacho FT, et al. Development and validation of a health-related quality of life instrument for women with melasma. Br J Dermatol. 2003; 149 (3): 572–7
Katsambas A, Antoniou C. Melasma: classification and treatment. J Fur Acad Dermatol Venereol. 1995; 4: 217–23
Engasser PG, Maibach HI. Cosmetic and dermatology: bleaching creams. J Am Acad Dermatol. 1981; 5 (2): 143–7
Kimbrough-Green CK, Griffiths CE, Finkel LJ, et al. Topical retinoic acid (tretinoin) for melasma in black patients: a vehicle-controlled clinical trial. Arch Dermatol. 1994; 130 (6): 727–33
Sanchez JL, Vazquez M. A hydroquinone solution in the treatment of melasma. Int J Dermatol. 1982; 21 (1): 5–8
Haddad AL, Matos LF, Brunstein F, et al. A clinical, prospective, randomized, double-blind trial comparing skin whitening complex with hydroquinone vs. placebo in the treatment of melasma. Int J Dermatol. 2003; 42 (2): 153–6
Griffiths CE, Finkel LJ, Ditre CM, et al. Topical tretinoin (retinoic acid) improves melasma: a vehicle-controlled, clinical trial. Br J Dermatol. 1993; 129 (4): 415–21
Taylor SC, Torok H, Jones T, et al. Efficacy and safety of a new triple-combination agent for the treatment of facial melasma. Cutis. 2003; 72 (1): 67–72
Torok H, Taylor S, Baumann L, et al. A large 12-month extension study of an 8-week trial to evaluate the safety and efficacy of triple combination (TC) cream in melasma patients previously treated with TC cream or one of its dyads. J Drugs Dermatol. 2005; 4 (5): 592–7
Torok HM, Jones T, Rich P, et al. Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: a safe and efficacious 12-month treatment for melasma. Cutis. 2005; 75 (1): 57–62
Grimes P, Kelly AP, Torok H, et al. Community-based trial of a triple-combination agent for the treatment of facial melasma. Cutis. 2006; 77 (3): 177–84
Gano SE, Garcia RL. Topical tretinoin, hydroquinone, and betamethasone valerate in the therapy of melasma. Cutis 1979; 23 (2): 239–41
Kang WH, Chun SC, Lee S. Intermittent therapy for melasma in Asian patients with combined topical agents (retinoic acid, hydroquinone and hydrocortisone): clinical and histological studies. J Dermatol. 1998; 25 (9): 587–96
Berardesca E, Maibach H. Ethnic skin: overview of structure and function. J Am Acad Dermatol. 2003; 48 (6 Suppl.): S139–42
Balkrishnan R, Kelly AP, McMichael A, et al. Improved quality of life with effective treatment of facial melasma. J Drugs Dermatol. 2004; 3 (4): 247–51
Giannotti B, Melli MC. Current approaches to the treatment of melasma. Clin Drug Invest. 1995; 10 Suppl. 2: 57–64
Kligman LH, Schwartz E, Lesnik RH, et al. Topical tretinoin prevents corticosteroid-induced atrophy without lessening the anti-inflammatory effect. Curr Probl Dermatol. 1993; 21: 79–88
McMichael AJ, Griffiths CE, Talwar HS, et al. Concurrent application of tretinoin (retinoic acid) partially protects against corticosteroid-induced epidermal atrophy. Br J Dermatol. 1996; 135 (1): 60–4
Acknowledgments
The author has acted as a consultant for Galderma Laboratories LP, Intendis, Coria, and Barrier Therapeutics; as a speaker for Galderma Laboratories LP, Allergan, Novartis, Amgen, and Genentech; and as an investigator for Collagenex, Medicis, Stiefel, and Dermik. No sources of funding were used to assist in the preparation of this review.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Torok, H.M. A Comprehensive Review of the Long-Term and Short-Term Treatment of Melasma with a Triple Combination Cream. Am J Clin Dermatol 7, 223–230 (2006). https://doi.org/10.2165/00128071-200607040-00003
Published:
Issue Date:
DOI: https://doi.org/10.2165/00128071-200607040-00003