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New products expand drug and device categories


The therapeutic armamentarium for dermatologic diseases continues to expand with the approval of several new products in 2015, and there appear to be more promising treatments on the horizon.

The therapeutic armamentarium for dermatologic diseases continues to expand with the approval of several new products in 2015, and there appear to be more promising treatments on the horizon, according to speakers at the MauiDerm 2016 meeting.

Two new foam products - azelaic acid 15% foam (Finacea,Bayer HealthCare) and calcipotriene 0.0005%/betamethasone dipropionate 0.064% foam (Enstilar, Leo Pharma) - were among the modalities highlighted in an update on new drugs and devices given by Neal Bhatia, M.D., and Ted Rosen, M.D.

The azelaic acid product is approved for the treatment of inflammatory papules and pustules of mild to moderate rosacea. The calcipotreine-betamethasone foam is approved for the treatment of plaque psoriasis in patients aged 18 and older.

“Although marketed as a foam, the calcipotriene-betamethasone combination comes out of its container more like a spray. For that reason, it may become a preferred option for topical treatment of large surface areas of plaque psoriasis on the body,” said Dr. Rosen, professor of dermatology, Baylor College of Medicine, Houston Texas.

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In the cosmetic realm, a synthetic version of deoxycholic acid (Kybella, Kythera) was approved in 2015 for the treatment of moderate-to-severe submental fat. This novel injectable adipocytolytic agent demonstrated superiority to placebo for reducing submental fat based on subjective rating scale assessments and for improving the psychological impact of submental fat.

A typical patient may be given two to four injections one month apart. The treatment is delivered under local anesthesia, and the cost can range from $2,500 to $4,000, Dr. Rosen said.

He added that another injectable agent is being developed by Neothetics for reduction of subcutaneous abdominal fat in nonobese indidviduals.

Looking ahead, crisaborole 2% ointment (Anacor), a non-steroidal topical anti-inflammatory phosphodiesterase-4 inhibitor, is now under FDA review for the treatment of mild-to-moderate atopic dermatitis. The sponsor submitted its New Drug Application in 2016 after achieving positive results in two phase 3 studies that enrolled patients aged two and up with mild-to-moderate disease.

Another novel investigational agent is a hydrogen peroxide solution (A-101, Aclaris) that is being developed for the treatment of seborrheic keratoses. Results of phase 2 studies showed dose-related efficacy in clearing lesions on the face, trunk, and extremities. Patients using the highest concentration, 40%, achieved a 68% clearance rate when assessed at 78 days after one or two applications.

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“Impressively, there was no residual dyschromia associated with its use,” said Dr. Bhatia, director of clinical dermatology, Therapeutics Clinical Research, San Diego, Calif.

In 2015, the FDA also approved civilian use of an expandable multisponge hemostatic dressing that had been available previously only for military personnel (XSTAT30 Dressing). This device, which is cellulose sponges coated with chitosan, is indicated for use in adults and adolescents at high risk for immediate, life-threatening, and severe hemorrhagic shock and non-compressible junctional wounds, when definitive care at an emergency care facility cannot be achieved within minutes.

Likely of greater interest to dermatologists is a published isolated case report in a single patient describing the successful use of topical brimonidine gel 3.3% as a hemostatic agent [Dermatol Surg. 2015;41(7):872-3]. The case involved a Mohs surgery wound that was still bleeding after 20 minutes of direct pressure. With application of topical brimonidine gel under gauze, complete hemostasis was achieved in 20 minutes.

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