Tri-Luma® Cream – 15 g

Tri-Luma® Cream is a prescription-only topical treatment indicated for the short-term (up to 8 weeks) management of moderate to severe melasma of the face, when used alongside strict sun-avoidance measures.

It is the only FDA-approved fixed-dose triple-combination cream specifically approved for facial melasma, containing a precise combination of fluocinolone acetonide, hydroquinone, and tretinoin. Manufactured by Galderma Laboratories, Tri-Luma® represents the highest standard in evidence-based melasma therapy.

What Makes Tri-Luma® Unique

• Only FDA-approved triple-combination cream for facial melasma
• Prescription-strength fixed-dose formulation
• Designed for short-term use only (up to 8 weeks)
• Clinically evaluated in large Phase 3 trials across Fitzpatrick skin types I–IV
• Dermatologist-prescribed worldwide

Active Ingredients & Their Role

• Fluocinolone Acetonide 0.01% – A mild topical corticosteroid that reduces inflammation and irritation caused by the other active agents, and inhibits melanin synthesis by decreasing cellular metabolism.
• Hydroquinone 4% – A depigmenting agent that interrupts the formation and synthesis of melanin to help even and lighten the skin.
• Tretinoin 0.05% – A retinoid that may prevent oxidation of hydroquinone, improves epidermal penetration and skin cell turnover, facilitating pigment elimination and reducing the risk of skin atrophy.

The exact mechanism of action of Tri-Luma® in melasma is not fully known.

Clinical Evidence & Benefits

Tri-Luma® Cream has been rigorously evaluated in two Phase 3, multicentre, randomised, investigator-blind, active-control, parallel-group trials (n=641 subjects, aged 21–75, Fitzpatrick skin types I–IV).

• 77% of patients achieved complete or near-complete clearing of facial melasma by Week 8 (Taylor SC et al., Cutis, 2003;72(1):67-72)
• Subjects were treated once daily at night for 8 weeks
• The triple-combination significantly outperformed any two-ingredient combination in the same vehicle
• Hydroquinone 4% has been shown to interrupt tyrosinase-mediated melanin biosynthesis (Vashi NA & Kundu RV, Br J Dermatol, 2013;169 Suppl 3:41-56)
• Tretinoin accelerates keratinocyte turnover, enhancing hydroquinone delivery and pigment elimination (Rendon et al., J Am Acad Dermatol, May 2006)
• Fluocinolone acetonide counteracts retinoid-induced irritation and provides additive depigmentation through suppression of cellular metabolic activity

Indication

Tri-Luma® Cream is indicated for the short-term treatment (up to 8 weeks) of moderate to severe melasma of the face, in conjunction with sun avoidance, broad-spectrum sunscreen (SPF 30 or higher), and protective clothing. It is not indicated for long-term use or maintenance therapy.

How to Use

• Apply a thin layer once daily at night to affected facial areas
• Use only as prescribed by a healthcare professional
• Avoid contact with eyes, mouth, and mucous membranes
• Wash hands thoroughly after application
• Use SPF 30+ sunscreen daily during treatment

Who Should NOT Use Tri-Luma®

• Pregnant or breastfeeding women
• Individuals allergic to sulfites or any listed ingredient
• Patients requiring long-term melasma maintenance
• Use in children has not been established

Always consult a healthcare professional before use.

Possible Side Effects

Common: redness, peeling, burning, dryness, itching at the application site. Rare but serious: allergic reactions (due to sulfites), blue-black skin darkening (ochronosis), adrenal suppression with prolonged use. Stop use and seek medical advice immediately if severe reactions occur.

Important Notes

• Tri-Luma® improves appearance but is not a cure for melasma
• Melasma may return after stopping treatment
• Long-term or repeated use is not recommended

Product Details

• Product Name: Tri-Luma® Cream
• Strength: Fluocinolone Acetonide 0.01% / Hydroquinone 4% / Tretinoin 0.05%
• Net Weight: 15 g
• Form: Topical cream
• Classification: Prescription-only medicine
• Application Area: Face only
• Manufacturer: Galderma Laboratories, L.P.

 A valid prescription is required. Always consult your doctor or dermatologist before use. Individual results may vary.