Dremz

Hydroquinone Topical (Dremz) is a topical lightening product found in OTC products, and is used to correct skin discoloration associated with disorders of hyperpigmentation including melasma, post-inflammatory hyperpigmention, sunspots, and freckles. It can be used alone, but is more frequently found in combination with other agents such as alpha-hydroxy acids, corticosteroids, retinoids, or sunscreen. Hydroquinone Topical (Dremz) has come under scrutiny due to several complications associated with its use, including dermal irritation, exogenous onchronosis, and carginogenicity. As a result of these concerns, Hydroquinone Topical (Dremz) has been banned in the EU and UK.

Cream: Each gram of Mometasone furoate (Mometasone Topical (Dremz)) Cream contains 1 mg mometasone furoate.

Ointment: Each gram of Mometasone furoate (Mometasone Topical (Dremz)) Ointment contains 1 mg mometasone furoate.

Lotion: Each gram of Mometasone furoate (Mometasone Topical (Dremz)) Lotion contains: 1 mg of mometasone furoate.

The Mometasone furoate (Mometasone Topical (Dremz)*) Cream, Ointment and Lotion formulations contain mometasone furoate (SCH 32088), a synthetic 17-heterocyclic corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties, which is presently being therapeutically used for the treatment of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.

Mometasone furoate, 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate, is a synthetic, anti-inflammatory corticosteroid whose steroid nucleus is the 16α-methyl analog of beclomethasone, but with a 21-chloro group and a novel (2)-furoate 17-ester function. The empirical formula is C₂₇H₃₀CI₂O₆ and Molecular Weight (MW) is 521.44.

Excipients/Inactive Ingredients: Cream: White petrolatum, white wax, propylene glycol stearate, stearyl alcohol and ceteareth-20, hexylene glycol, titanium dioxide, aluminum starch octenylsuccinate, purified water and phosphoric acid to adjust the pH.

Ointment: Hexylene glycol, white wax, propylene glycol stearate, white petrolatum, purified water and phosphoric acid to adjust the pH.

Lotion: Isopropyl alcohol, hydroxypropylcellulose, sodium phosphate monobasic monohydrate, propylene glycol, purified water and phosphoric acid, if needed, to adjust the pH.

Tretinoin Topical (Dremz), also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as tretinoin are important regulators of cell reproduction, proliferation, and differentiation and are used to treat acne and photodamaged skin and to manage keratinization disorders such as ichthyosis and keratosis follicularis. Tretinoin Topical (Dremz) also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL).

Clarifying Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. It is intended for night-time use only since it contains no sunscreen agents. For daytime usage, Glytone SunVanish should be prescribed.

Mometasone Topical (Dremz) (mometasone furoate lotion), 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses. Since safety and efficacy of Mometasone Topical (Dremz) (mometasone furoate lotion) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended..

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

Tretinoin Topical (Dremz) (tretinoin cream) 0.05% is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs. Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.

• Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) 0.05% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
• Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sunlight avoidance program alone.
• The effectiveness of Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) 0.05%. Thus the effectiveness and safety of Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) 0.05% in these populations are not known at this time.
• Neither the safety nor the effectiveness of Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials.

Hydroquinone Topical (Dremz) decreases the formation of melanin in the skin. Melanin is the pigment in skin that gives it a brown color.

Hydroquinone Topical (Dremz) (for the skin) is used to lighten areas of darkened skin such as freckles, age spots, melasma (sun damage), or chloasma (darkened skin caused by hormonal changes).

Hydroquinone Topical (Dremz) may also be used for purposes not listed in this medication guide.

Mometasone Topical (Dremz) (mometasone) is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation.

Mometasone Topical (Dremz) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Mometasone Topical (Dremz) may also be used for other purposes not listed in this medication guide.

Tretinoin Topical (Dremz) (tretinoin) is a form of vitamin A that helps the skin renew itself.

The Tretinoin Topical (Dremz) and Avita brands of tretinoin are used to treat acne. The Tretinoin Topical (Dremz) brand of tretinoin is used to reduce the appearance of fine wrinkles and mottled skin discoloration, and to make rough facial skin feel smoother.

Tretinoin Topical (Dremz) may also be used for purposes not listed in this medication guide.

Usual Adult Dose for Dermatological Disorders

Chloasma, Melasma, Freckles, Senile lentigines, Areas of melanin hyperpigmentation:

Apply to affected area twice daily.

Usual Pediatric Dose for Dermatological Disorders

Chloasma, Melasma, Freckles, Senile lentigines, Areas of melanin hyperpigmentation:

>=13 years: Apply to affected area twice daily.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Hydroquinone Topical (Dremz) is contraindicated for use during pregnancy and in children 12 years of age or younger.

Patients should be tested for skin sensitivity prior to initiating treatment with Hydroquinone Topical (Dremz). A small amount of the drug should be applied to an unbroken area of skin and the test area should be examined after 24 hours. If excessive inflammation is present, the manufacturer recommends against the use of the drug. Minor redness is not a contraindication.

Avoid contact with the eyes.

Hydroquinone Topical (Dremz) is a skin bleaching agent and may produce unwanted cosmetic effects.

Sun exposure should be avoided on bleached skin by applying a sunscreen or by the use of protective clothing.

The drug should be discontinued if no bleaching or lightening effect is visible after 2 months of treatment.

Dialysis

Data not available

Apply a thin film of Mometasone Topical (Dremz) to the affected skin areas once daily. Mometasone Topical (Dremz) may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Topical (Dremz) have not been established in pediatric patients below 2 years of age; use in this age group is not recommended.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of Mometasone Topical (Dremz) in pediatric patients for more than 3 weeks of use have not been established.

Mometasone Topical (Dremz) should not be used with occlusive dressings unless directed by a physician. Mometasone Topical (Dremz) should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

Mometasone Topical (Dremz) is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.

How supplied

Dosage Forms And Strengths

Cream, 0.1%. Each gram of Mometasone Topical (Dremz) contains 1 mg of mometasone furoate in a white to off-white smooth and homogenous cream base.

Storage And Handling

Mometasone Topical (Dremz) is white to off-white in color and supplied in 15-gram (NDC 0085-3149-01) and 50-gram (NDC 0085-3149-03) tubes.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Avoid excessive heat.

Manufactured for : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Schering-Plough Labo NV Heist-op-den-Berg, Belgium. Revised: Apr 2013

• Do NOT use Tretinoin Topical (Dremz) [Tretinoin Cream, USP (Emollient) 0.05%] if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy
• Do NOT use Tretinoin Topical (Dremz) if the patient is sunburned or if the patient has eczema or other chronic skin condition(s)
• Do NOT use Tretinoin Topical (Dremz) if the patient is inherently sensitive to sunlight
• Do NOT use Tretinoin Topical (Dremz) if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

Tretinoin Topical (Dremz) should be applied to the face once a day before retiring, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Tretinoin Topical (Dremz). The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Tretinoin Topical (Dremz) [Tretinoin Cream, USP (Emollient) 0.05%] may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Tretinoin Topical (Dremz) is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Tretinoin Topical (Dremz) therapy, a majority of patients will lose most mitigating effects of Tretinoin Topical (Dremz) on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Tretinoin Topical (Dremz) daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with Tretinoin Topical (Dremz) may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

See also:
What is the most important information I should know about Hydroquinone Topical (Dremz)?

LUSTRA® and LUSTRA-AF® are contraindicated in any patient that has a prior history of hypersensitivity or allergic reaction to Hydroquinone Topical (Dremz) or any of the other ingredients. The safety of topical Hydroquinone Topical (Dremz) use during pregnancy or on children (12 years and under) has not been established.

See also:
What is the most important information I should know about Mometasone Topical (Dremz)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Mometasone Topical (Dremz) can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

See also:
What is the most important information I should know about Tretinoin Topical (Dremz)?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tretinoin Topical (Dremz) can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use Tretinoin Topical (Dremz) on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using Tretinoin Topical (Dremz).

Use this medication for as many days as it has been prescribed for you even if you think it is not working. It may take weeks or months of use before you notice improvement in your skin. If you are using Tretinoin Topical (Dremz) to treat acne, your condition may get slightly worse for a short time when you first start using the medication. Call your doctor if skin irritation becomes severe or if your acne does not improve within 8 to 12 weeks.

Use Hydroquinone Topical (Dremz) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydroquinone Topical (Dremz) comes with an additional patient leaflet. Read it carefully and reread it each time you get Hydroquinone Topical (Dremz) refilled.
• Hydroquinone Topical (Dremz) is for external use only.
• Before using Hydroquinone Topical (Dremz) for the first time, apply a small amount to an unbroken patch of skin and check in 24 hours for itching, blistering, or excessive redness or irritation. If these side effects develop, contact your doctor.
• Wash your hands before and after using Hydroquinone Topical (Dremz), unless your hands are a part of the treated area.
• Remove all cosmetics with a mild soap before applying Hydroquinone Topical (Dremz). Gently dry the area.
• Apply enough medicine to cover the affected area and gently rub it in until it is evenly distributed.
• If you miss a dose of Hydroquinone Topical (Dremz), use it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydroquinone Topical (Dremz).

Use Mometasone Topical (Dremz) as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• Apply a small amount of Mometasone Topical (Dremz) to the affected area once a day. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using Mometasone Topical (Dremz), unless your hands are part of the treated area.
• If you miss a dose of Mometasone Topical (Dremz), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mometasone Topical (Dremz).

Use Tretinoin Topical (Dremz) exactly as your doctor has prescribed it for you. Using more medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects. Do not use Tretinoin Topical (Dremz) for longer than your doctor has prescribed.

Do not take by mouth. Tretinoin Topical (Dremz) is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Wash your hands before and after applying Tretinoin Topical (Dremz) Cream. You should apply Tretinoin Topical (Dremz) Cream to your face once a day before retiring using only enough to cover the entire affected area lightly. Gently wash your face with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying the cream. Apply a pea-sized amount of cream to cover your entire face. You may feel a warmth or slight stinging when Tretinoin Topical (Dremz) Cream is first applied.

You must be especially careful when applying the cream to avoid your eyes, ears, nostrils, or mouth. Tretinoin Topical (Dremz) may cause severe redness, itching, burning, stinging, and peeling if applied to these areas.

Using larger than necessary amounts of Tretinoin Topical (Dremz) will not speed results and can cause an overdose. An overdose can result in red and peeling skin as well as some pain or discomfort.

Applying Tretinoin Topical (Dremz) to wet skin may cause skin irritation. Wait at least 20 minutes after washing your face before applying a thin layer of the medication.

Do not wash the treated area for at least 1 hour after applying Tretinoin Topical (Dremz). Avoid the use of other skin products on the treated area for at least 1 hour following application of Tretinoin Topical (Dremz).

Tretinoin Topical (Dremz) should be used as part of a complete skin care program that includes avoiding sunlight and using an effective sunscreen and protective clothing.

Use this medication for the full prescribed length of time, even if you think it is not working.

It may take up to several weeks before you notice improvement in your skin. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Hydroquinone Topical (Dremz) is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin. This product also contains sunscreens to help prevent spots from returning due to sunlight or ultraviolet light exposure.

This medicine works by blocking the process in the skin that leads to discoloration.

How to use Hydroquinone Topical (Dremz) topical

Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.

Apply this medication to the affected areas of skin, usually twice daily or as directed by your doctor. This medication is for use on the skin only. If it is used incorrectly, unwanted skin lightening may occur. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water.

This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps, and wear protective clothing on the treated areas of skin when outdoors. This product contains a sunscreen, but it should not be used as a sunscreen for other skin that is not being treated for discoloration. Instead, apply a separate sunscreen of SPF 15 or greater to your normal skin.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition persists or worsens after 2 months.

Mometasone Topical (Dremz) is used to treat symptoms of allergic rhinitis (hay fever), perennial rhinitis (symptoms lasting almost a year) and nasal polyps (fleshy swelling inside the nose). It is used to treat inflammation and various skin conditions like eczema (inflammation and blistering on skin in patches causing redness and bleeding), psoriasis (red, itchy, scaly patches on skin), and dermatitis (redness and swelling of skin due to allergy).

Use: Labeled Indications

Acne vulgaris: Tretinoin Topical (Dremz), Tretinoin Topical (Dremz), Avita, Tretinoin Topical (Dremz), Tretinoin Topical (Dremz), Tretinoin Topical (Dremz) [Canadian product], Tretin-X, Vitamin-A Acid [Canadian product]: Treatment of acne vulgaris.

Palliation of fine wrinkles: Tretinoin Topical (Dremz): Adjunctive treatment for mitigation (palliation) of fine wrinkles in patients who use comprehensive skin care and sun avoidance programs.

Palliation of fine wrinkles, mottled hyperpigmentation, and facial skin roughness: Tretinoin Topical (Dremz): Adjunctive treatment for mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone.

See also:
What other drugs will affect Hydroquinone Topical (Dremz)?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

See also:
What other drugs will affect Mometasone Topical (Dremz)?

No drug-drug interaction studies have been conducted with Mometasone Topical (Dremz).

See also:
What other drugs will affect Tretinoin Topical (Dremz)?

Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) because they may increase irritation with Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%).

Tretinoin Topical (Dremz) (tretinoin emollient cream 0.05%) should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.

See also:
What are the possible side effects of Hydroquinone Topical (Dremz)?

Applies to Hydroquinone Topical (Dremz): topical combination cream, topical cream gel emulsion or solution

Side effects include:

Mild skin irritation and sensitization (e.g., burning, erythema, stinging).

See also:
What are the possible side effects of Mometasone Topical (Dremz)?

Applies to Mometasone Topical (Dremz): topical application cream, topical application lotion, topical application ointment, topical application solution

In addition to its needed effects, some unwanted effects may be caused by Mometasone Topical (Dremz) (the active ingredient contained in Mometasone Topical (Dremz)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Mometasone Topical (Dremz):

Less common:

• Burning
• itching
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

• Dryness
• irritation
• redness and scaling around the mouth

Minor Side Effects

Some of the side effects that can occur with Mometasone Topical (Dremz) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Acne or pimples
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• dry mouth
• loss of elasticity
• loss of normal skin markings
• raised, dark red, and wart-like spots on the skin, especially when used on the face
• shininess

• Burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin

See also:
What are the possible side effects of Tretinoin Topical (Dremz)?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials in Subjects with Acne

In separate clinical trials for each concentration, acne subjects treated with Tretinoin Topical (Dremz) (tretinoin) Gel microsphere 0.1% or 0.04%, over the twelve week period showed that cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching peaked during the initial two weeks of therapy, decreasing thereafter.

Approximately half of the subjects treated with Tretinoin Topical (Dremz) 0.04% had cutaneous irritation at Week 2. Of those subjects who did experience cutaneous side effects, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe). Less than 10% of patients experienced moderate cutaneous irritation and there was no severe irritation at Week 2.

In trials of Tretinoin Topical (Dremz) (tretinoin) Gel microsphere 0.04%, throughout the treatment period the majority of subjects experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of subjects having scores indicative of a severe irritation; 1.3% (3/225) of subjects treated with Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.

In trials of Tretinoin Topical (Dremz) (tretinoin) Gel microsphere 0.1%, no more than 3% of subjects had cutaneous irritation scores indicative of severe irritation; 6% (14/224) of subjects treated with Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1% discontinued treatment due to irritation. Of these 14 subjects, four had severe irritation after 3 to 5 days of treatment, with blistering in one subject.

In a double-blind trial with 156 acne subjects comparing 12 weeks of treatment with Tretinoin Topical (Dremz) (tretinoin) Gel 0.04% or 0.1% (78 subjects each group), the most frequently-reported adverse events affected the skin and subcutaneous tissue (15.4% in the 0.04% group, and 20.5% in the 0.1% group). The most prevalent of the dermatologic adverse events in the 0.04% group was skin irritation (6.4%); and in the 0.1% group skin burning (7.7%), erythema (5.1%), skin irritation (3.8%), and dermatitis (3.8%). Most adverse events were of mild intensity (63.4%), and 34.4% were moderate. One subject in each group had adverse events characterized as severe, neither were dermatologic findings and neither was characterized as related to drug by the investigator.

Trials in Subjects Without Acne

In a half-face comparison trial conducted for up to 14 days in women with sensitive skin, but without acne, Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1% was statistically less irritating than tretinoin cream, 0.1%. In addition, a cumulative 21 day irritation evaluation in subjects with normal skin showed that Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1%, had a lower irritation profile than tretinoin cream, 0.1%. The clinical significance of these irritation studies for patients with acne is not established. Comparable effectiveness of Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1% and tretinoin cream, 0.1%, has not been established. The lower irritancy of Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1% in subjects without acne may be attributable to the properties of its vehicle. The contribution of decreased irritancy by the MICROSPONGE System has not been established. No irritation trials have been performed to compare Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.04%, with either Tretinoin Topical (Dremz) (tretinoin) Gel microsphere, 0.1%, or tretinoin cream, 0.1%.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Tretinoin Topical (Dremz) Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin.