Dab

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

Complex A™ Dab Cream, USP (Emollient) 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 do not achieve such palliation using comprehensive skin care and sun avoidance programs. COMPLEX A™ Dab CREAM, USP (EMOLLIENT) DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing Dab.

• Complex A™ Dab Cream, USP (Emollient) 0.05% has demonstrated NO MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangi-ectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.

• Complex A™ Dab Cream, USP (Emollient) 0.05% should be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sun-screens (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 sun avoidance program alone.

• The effectiveness of Complex A™ Dab Cream, USP (Emollient) 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 Complex A™ Dab Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Complex A™ Dab Cream, USP (Emollient) 0.05% in these populations are not known at this time.

• Neither the safety nor the effectiveness of Complex A™ Dab Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using Complex A™ Dab Cream, USP (Emollient) 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.

Dab is used to treat acne. It works partly by keeping skin pores clear.

One of the Dab creams is used to treat fine wrinkles, dark spots, or rough skin on the face caused by damaging rays of the sun. It works by lightening the skin, replacing older skin with newer skin, and by slowing down the way the body removes skin cells that may have been harmed by the sun. Dab works best when used within a skin care program that includes protecting the treated skin from the sun. However, it does not completely or permanently erase these skin problems or greatly improve more obvious changes in the skin, such as deep wrinkles caused by sun or the natural aging process.

Dab may also be used to treat other skin diseases as determined by your doctor.

Dab is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, Dab is used in certain patients with the following medical conditions:

• Keratosis follicularis (skin disorder of small, red bumps)
• Verruca plana (flat warts)

• Do NOT use Complex A™ Dab Cream, USP (Emollient) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy
• Do NOT use Complex A™ Dab Cream, USP (Emollient) if the patient is sunburned or if the patient has eczema or other chronic skin condition(s)
• Do NOT use Complex A™ Dab Cream, USP (Emollient) if the patient is inherently sensitive to sunlight
• Do NOT use Complex A™ Dab Cream, USP (Emollient) 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.

Complex A™ Dab Cream, USP (Emollient) 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 Complex A™ Dab Cream, USP (Emollient). 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 Complex A™ Dab Cream, USP (Emollient) 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 Complex A™ Dab Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Complex A™ Dab Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Complex A™ Dab Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Complex A™ Dab Cream, USP (Emollient) 0.05% 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 Complex A™ Dab Cream, USP (Emollient) 0.05% 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 Dab?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Dab topical 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 Dab topical 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 Dab topical.

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 Dab topical 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 Dab emollient cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Dab emollient cream. Talk to your pharmacist if you have questions about this information.
• Dab emollient cream is for external use only.
• Remove all cosmetics with a mild soap before applying Dab emollient cream. Gently dry the area. Wait 20 to 30 minutes to make sure that skin is completely dry.
• Squeeze a small amount (quarter inch or less) of the medicine onto the fingertip. This should be enough to cover the entire affected area. Wash your hands immediately after using Dab emollient cream.
• If you miss a dose of Dab emollient cream, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Dab emollient cream.

Use: Labeled Indications

Acute promyelocytic leukemia (remission induction): Induction of remission in patients with acute promyelocytic leukemia, French American British (FAB) classification M3 (including the M3 variant) characterized by t(15;17) translocation and/or PML/RARα gene presence

Off Label Uses

Acute promyelocytic leukemia (consolidation therapy)

Data from studies of combination chemotherapy in adults with acute promyelocytic leukemia (APL) support the use of Dab as part of the consolidation phase of treatment.

See also:
What other drugs will affect Dab?

Limited clinical data on potential drug interactions are available.

Drugs Metabolized By the Hepatic P450 System

As Dab (Dab) is metabolized by the hepatic P450 system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Medications that generally induce hepatic P450 enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P450 enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine. To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of Dab (Dab).

Agents Known to Cause Pseudotumor Cerebri/Intracranial Hypertension (Such as Tetracyclines)

Dab (Dab) may cause pseudotumor cerebri/intracranial hypertension. Concomitant administration of Dab (Dab) and agents known to cause pseudotumor cerebri/intracranial hypertension as well might increase the risk of this condition.

Vitamin A

As with other retinoids, Dab (Dab) must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

Anti-fibrinolytic Agents (Such as Tranexamic Acid, Aminocaproic Acid, or Aprotinin)

Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with Dab (Dab) and anti-fibrinolytic agents. Therefore, caution should be exercised when administering Dab (Dab) concomitantly with these agents.

Effect of Food

No data on the effect of food on the absorption of Dab (Dab) are available. The absorption of retinoids as a class has been shown to be enhanced when taken together with food.

See also:
What are the possible side effects of Dab?

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 Dab gel, USP (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 Dab gel, USP (microsphere) 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 Dab gel, USP (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 Dab gel, USP (microsphere) 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.

In trials of Dab gel, USP (microsphere) 0.1%, no more than 3% of subjects had cutaneous irritation scores indicative of severe irritation; 6% (14/224) of subjects treated with Dab gel, USP (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 Dab gel, USP (microsphere) 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, Dab gel, USP (microsphere) 0.1% was statistically less irritating than Dab cream, 0.1%. In addition, a cumulative 21 day irritation evaluation in subjects with normal skin showed that Dab gel, USP (microsphere) 0.1%, had a lower irritation profile than Dab cream, 0.1%. The clinical significance of these irritation trials for patients with acne is not established. Comparable effectiveness of Dab gel, USP (microsphere) 0.1% and Dab cream, 0.1%, has not been established. The lower irritancy of Dab gel, USP (microsphere) 0.1% in subjects without acne may be attributable to the properties of its vehicle. The contribution of decreased irritancy by the methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres has not been established. No irritation trials have been performed to compare Dab gel, USP (microsphere) 0.04%, with either Dab gel, USP (microsphere) 0.1%, or Dab cream, 0.1%.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Dab gel, USP (microsphere). 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 Dab.

Dab, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as Dab 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. Dab also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL).