Triluma Cream

TRI-LUMA® (fluocinolone acetonide, hydroquinone, tretinoin) cream 0.01%/4%/0.05% is the only FDA-approved topical treatment available to help reduce the appearance of dark spots associated with moderate-to-severe facial melasma.1

*Tri-Luma Cream is the only approved prescription, fixed-dose combination containing hydroquinone for facial melasma.

Possible Side Effects of Tri-Luma Cream
Some patients may have very severe allergic reactions to Tri-Luma Cream due to the sulfites contained in the product. In some cases, these allergic reactions may result in severe asthma attacks, which can be life threatening.

While you use Tri-Luma Cream, your skin may develop mild-to-moderate redness, peeling, burning, dryness, or itching.

Tri-Luma Cream contains a corticosteroid medicine as one of its active components. The following side effects have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of the hair follicle, acne, changes in skin color, inflammation around the mouth, allergic skin reaction, skin infection, skin thinning, stretch marks and sweat problems.

In addition, Tri-Luma Cream contains a corticosteroid that may produce reversible effects on the adrenal gland called hypothalamic-pituitary-adrenal (HPA) axis suppression, so tell your doctor if you have any condition that may affect your adrenal function, such as Addison’s disease.

Some patients using Tri-Luma Cream develop dark spots on their skin, tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red lines or blood vessels showing through the skin. Tri-Luma Cream may also cause a gradual blue-black darkening of your skin; if this happens, stop using the product immediately and speak to your doctor.

If you are concerned about how your skin is reacting to Tri-Luma Cream, call your doctor.

Stopping Treatment with Tri-Luma Cream
Stop using Tri-Luma Cream and contact your doctor if you experience:

Severe or continued irritation, blistering, oozing, scaling, or crusting
Severe burning or swelling of your skin
Irritation of your eyes, nose, or mouth
Any type of breathing problem
Blue-black coloration on your skin where the cream was applied

What to Avoid While Using Tri-Luma Cream
You should avoid sunlight and ultraviolet light. Tri-Luma Cream can make your skin more likely to get sunburned or develop other unwanted effects from natural or artificial sunlight (as from a sunlamp or tanning bed). Dark skin patches may also become darker when your skin is exposed to sunlight. Any level of sun exposure can contribute to or trigger melasma—you don’t have to be sunburned to make your melasma worse.

It is important to protect your skin from the sun to help prevent further darkening of existing dark patches and the formation of new ones.

Staying out of the sun is especially important for women who take birth control pills or hormone replacement therapy, and for people who have had dark patches in the past.

Follow these guidelines regarding sun exposure when using Tri-Luma Cream:

Use an effective sunscreen any time you are outside, even on hazy days. The sunscreen should have an SPF (sun protection factor) of 30 or more. Use sunscreen year-round on areas of the skin that are regularly exposed to sunlight, such as your face and hands. If possible, protect the treated area from sunlight exposure.
If you spend a lot of time outside, be especially careful of sunlight. Ask your doctor what SPF level will give you the needed high level of protection. If you will be outside, wear protective clothing, including a hat.
Do not use sunlamps or any artificial source of sunlight (such as tanning beds) while you use Tri-Luma Cream.
Skin treated with Tri-Luma Cream may be more likely to react to heat and cold than untreated skin. Your doctor can recommend ways to manage your melasma under these conditions.

While using Tri-Luma Cream, you should avoid products that may dry or irritate your skin. These may include soaps and cleansers that are rough or cause dryness; certain astringents, such as alcohol-containing products, soaps and toiletries containing alcohol, spices, or lime; or certain medicated soaps, shampoos, and hair permanent products.

Do not use any other medicines with Tri-Luma Cream unless you have consulted your doctor. The medicines and products you have used in the past may cause redness or peeling when used with Tri-Luma Cream.