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About Lazma

No one is really certain exactly what causes melasma, but there are many factors that can trigger it including pregnancy, birth control pills, hormone therapy, cosmetics, and anti-seizure medications. Because melasma is so common during pregnancy, it is sometimes referred to as “the mask of pregnancy.” Sun exposure is also a major melasma trigger because ultraviolet (UV) light from the sun can increase melanin production.

 


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Lazma is the only FDA-approved melasma treatment with 3 active ingredients, uniquely combined and more effective then treatments containing only two of the ingredients.

Lazma Cream is a unique triple-combination topical therapy for the short-term (8-week ) treatment of the dark spots associated with moderate-to-severe facial melasma.

1.

Fluocinolone acetonide 0.01% is a mild corticosteroid that reduces inflammation.

2.

Hydroquinone 4% is a depigmenting agent that interrupts the formation and synthesis of melanin to help lighten the skin.

3.

Tretinoin 0.05% works by increasing the skin cell turnover rate, which helps exfoliate the skin.

Lazma Cream should always be used in conjunction with sun-avoidance measures, like using sunscreens and wearing protective clothing. Lazma improves the appearance of melasma but continous therapy is required for sustainable results.


How to apply Lazma Cream

Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) should always be used as instructed by your doctor. To use the medicine correctly, follow these steps:

  • Apply Lazma® Cream at night, at least 30 minutes before bedtime.
  • Gently wash your face with a mild cleanser. Don’t use a washcloth to apply the cleanser, just your fingers. Rinse and pat your skin dry.
  • Put a small amount (pea sized or ½ inch or less) of Lazma Cream on your fingertip. Apply a thin coat onto the discolored spot(s). Include about ½ inch of normal skin surrounding the affected area.
  • After you have used the medicine for a while, you may find that you need slightly less to do the job.
  • Rub the medicine lightly and uniformly into your skin. The medicine should become invisible almost at once. If you can still see it, you are using too much.
  • Keep the medicine away from the corners of your nose, your mouth, eyes and open wounds. Spread it away from those areas when applying it.
  • Do not use more Lazma Cream or apply it more often than recommended by your doctor. Too much Lazma Cream may irritate your skin and won’t give you faster or better results.
  • Do not cover the treated area with anything after applying Lazma Cream.
  • During use of Lazma Cream, you may experience redness, peeling, burning, dryness, itching or other skin irritation. If your skin gets too irritated, stop using Lazma Cream, and let your doctor know. Lazma 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. To help avoid skin dryness, you may use a moisturizer in the morning after you wash your face.
  • You may also use a moisturizer and cosmetics during the day.

Use a sunscreen of at least SPF 30 and a wide-brimmed hat over the treated areas. It requires only a small amount of sunlight—not just a sunburn—to worsen melasma. If you do get sunburned, stop using Lazma Cream until your skin is healed. After stopping treatment with Lazma Cream, continue to protect your skin from sunlight.

Only your doctor knows which other medicines may be helpful during treatment and will tell you about them if needed. Do not use other medicines unless your doctor approves them.

Who should not use Lazma Cream

You should not use Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) if you are allergic to sulfites, as you may have a life-threatening allergic reaction. You should also not use Lazma Cream if you are allergic to any of its ingredients. Please refer to the full prescribing information for a complete list of ingredients.

You should also be aware that the use of Lazma Cream in pregnant women may carry the chance of causing birth defects in the baby. Tell your doctor if you are pregnant, may be pregnant, or plan to become pregnant.

Your doctor will talk with you about the benefits and risks of using Lazma Cream during pregnancy to help decide if the benefits for you are greater than the risks. You may decide to delay treatment until after your baby is born. Using Lazma Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

The safety and efficacy of Lazma Cream in people with darker skin (Fitzpatrick skin types V and VI) has not been studied. In addition, Lazma 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.

Only your doctor can determine if Lazma Cream is the appropriate treatment option for you.

What to expect from treatment with Lazma Cream

Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) may improve your melasma, but it is not a cure.

In studies, after 8 weeks of treatment with Lazma Cream, most patients with moderate-to-severe melasma had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another). In most patients treated with Lazma Cream, their melasma came back after treatment was discontinued.

If the underlying causes of melasma—such as the use of certain birth control pills or too much exposure to sunlight—are not removed, melasma will come back when you stop treatment.


What to avoid while using Lazma Cream

You should avoid sunlight and ultraviolet light. Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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 Lazma 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 Lazma Cream.

 

Skin treated with Lazma 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 Lazma 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 Lazma 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 Lazma Cream.

Possible side effects of Lazma Cream

Some patients may have very severe allergic reactions to Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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 Lazma Cream, your skin may develop mild-to-moderate redness, peeling, burning, dryness, or itching.

Lazma 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, Lazma 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 Lazma 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. Lazma 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 Lazma Cream, call your doctor.

Stopping treatment with Lazma Cream

Stop using Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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

 

If you become pregnant while taking Lazma Cream, tell your doctor right away.

You should discuss the chances that your baby may be harmed. Using Lazma Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

Additionally, Lazma Cream is indicated for the short-term (up to 8 weeks) treatment of moderate-to-severe melasma of the face. It is not indicated for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.


Where can I get Lazma® Cream?

Only your doctor, dermatologist, or other licensed health care professional can determine ifLazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is a good treatment option for you. If you and your doctor decide onLazma Cream for the treatment of your moderate-to-severe melasma, you can obtain your prescription either through your doctor’s office or at a pharmacy.

When does Lazma® Cream begin working?

Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is indicated for the short-term (up to 8 weeks) treatment of moderate-to-severe melasma of the face. It is not for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.

In studies, patients experienced improvement of their melasma with the use ofLazma Cream as early as 4 weeks. After 8 weeks of treatment withLazma Cream, most patients had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another), but most subjects had their melasma recur after treatment was discontinued.

How long do the results last?

If the underlying causes of melasma—such as the use of certain birth control pills or too much exposure to sunlight—are not removed, melasma will most likely come back when you stop treatment. In studies, most patients treated with Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) over 8 weeks saw their melasma come back after concluding treatment.

Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) may improve the appearance of your melasma, but it is not a cure.


How to apply Lazma Cream

Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) should always be used as instructed by your doctor. To use the medicine correctly, follow these steps:

  • Apply Lazma® Cream at night, at least 30 minutes before bedtime.
  • Gently wash your face with a mild cleanser. Don't use a washcloth to apply the cleanser, just your fingers. Rinse and pat your skin dry.
  • Put a small amount (pea sized or ½ inch or less) of Lazma Cream on your fingertip. Apply a thin coat onto the discolored spot(s). Include about ½ inch of normal skin surrounding the affected area.
  • After you have used the medicine for a while, you may find that you need slightly less to do the job.
  • Rub the medicine lightly and uniformly into your skin. The medicine should become invisible almost at once. If you can still see it, you are using too much.
  • Keep the medicine away from the corners of your nose, your mouth, eyes and open wounds. Spread it away from those areas when applying it.
  • Do not use more Lazma Cream or apply it more often than recommended by your doctor. Too much Lazma Cream may irritate your skin and won't give you faster or better results.
  • Do not cover the treated area with anything after applying Lazma Cream.
  • During use of Lazma Cream, you may experience redness, peeling, burning, dryness, itching or other skin irritation. If your skin gets too irritated, stop using Lazma Cream, and let your doctor know. Lazma 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. To help avoid skin dryness, you may use a moisturizer in the morning after you wash your face.
  • You may also use a moisturizer and cosmetics during the day.

Use a sunscreen of at least SPF 30 and a wide-brimmed hat over the treated areas. It requires only a small amount of sunlight—not just a sunburn—to worsen melasma. If you do get sunburned, stop using Lazma Cream until your skin is healed. After stopping treatment with Lazma Cream, continue to protect your skin from sunlight.

Only your doctor knows which other medicines may be helpful during treatment and will tell you about them if needed. Do not use other medicines unless your doctor approves them.

Who should not use Lazma Cream

You should not use Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) if you are allergic to sulfites, as you may have a life-threatening allergic reaction. You should also not use Lazma Cream if you are allergic to any of its ingredients. Please refer to the full prescribing information for a complete list of ingredients.

You should also be aware that the use of Lazma Cream in pregnant women may carry the chance of causing birth defects in the baby. Tell your doctor if you are pregnant, may be pregnant, or plan to become pregnant.

Your doctor will talk with you about the benefits and risks of using Lazma Cream during pregnancy to help decide if the benefits for you are greater than the risks. You may decide to delay treatment until after your baby is born. Using Lazma Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

The safety and efficacy of Lazma Cream in people with darker skin (Fitzpatrick skin types V and VI) has not been studied. In addition, Lazma 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.

Only your doctor can determine if Lazma Cream is the appropriate treatment option for you.

What to expect from treatment with Lazma Cream

Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) may improve your melasma, but it is not a cure.

In studies, after 8 weeks of treatment with Lazma Cream, most patients with moderate-to-severe melasma had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another). In most patients treated with Lazma Cream, their melasma came back after treatment was discontinued.

If the underlying causes of melasma—such as the use of certain birth control pills or too much exposure to sunlight—are not removed, melasma will come back when you stop treatment.


What to avoid while using Lazma Cream

You should avoid sunlight and ultraviolet light. Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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 Lazma 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 Lazma Cream.

Skin treated with Lazma 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 Lazma 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 Lazma 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 Lazma Cream.

Possible side effects of Lazma Cream

Some patients may have very severe allergic reactions to Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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 Lazma Cream, your skin may develop mild-to-moderate redness, peeling, burning, dryness, or itching.

Lazma 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, Lazma 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 Lazma 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. Lazma 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 Lazma Cream, call your doctor.

Stopping treatment with Lazma Cream

Stop using Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) 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

If you become pregnant while taking Lazma Cream, tell your doctor right away.

You should discuss the chances that your baby may be harmed. Using Lazma Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.

Additionally, Lazma Cream is indicated for the short-term (up to 8 weeks) treatment of moderate-to-severe melasma of the face. It is not indicated for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.


Where can I get Lazma® Cream?

Only your doctor, dermatologist, or other licensed health care professional can determine ifLazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is a good treatment option for you. If you and your doctor decide onLazma Cream for the treatment of your moderate-to-severe melasma, you can obtain your prescription either through your doctor's office or at a pharmacy.

When does Lazma® Cream begin working?

Lazma Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is indicated for the short-term (up to 8 weeks) treatment of moderate-to-severe melasma of the face. It is not for long-term use (more than 8 weeks) or for the maintenance of melasma symptoms.

In studies, patients experienced improvement of their melasma with the use ofLazma Cream as early as 4 weeks. After 8 weeks of treatment withLazma Cream, most patients had at least some improvement. Some had their dark spots clear up completely (38% in one study and 13% in another), but most subjects had their melasma recur after treatment was discontinued.

How long do the results last?

If the underlying causes of melasma—such as the use of certain birth control pills or too much exposure to sunlight—are not removed, melasma will most likely come back when you stop treatment. In studies, most patients treated with Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) over 8 weeks saw their melasma come back after concluding treatment.

Lazma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) may improve the appearance of your melasma, but it is not a cure.