Taltz Label Updated to Include Data on Psoriasis Affecting Genital Area

The approval was based on data from a randomized, placebo-controlled trial that included 149 adults with plaque psoriasis who had a minimum body surface area (BSA) involvement of 1%, a static Physician Global Assessment (sPGA) score of ≥3 (moderate psoriasis), a sPGA of Genitalia score of ≥3 (moderate psoriasis involving the genital area), who failed to respond to or were intolerant of at least one topical therapy used for the treatment of psoriasis affecting the genital area, and who were candidates for phototherapy and/or systemic therapy.

Topical Treatment for Epidermolysis Bullosa Gets FDA's Rare Pediatric Designation

A previous Phase 2 trial of 17 patients with EBS showed that 60% of those treated with diacerein cream experienced at least a 40% reduction in blistering after 4 weeks vs 18% on vehicle.

Positive Results for Dupilumab in Teen Atopic Dermatitis Trial

The primary endpoint was the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) at Week 16.

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis Causes, Treatment Investigated

The multicenter retrospective study (N=377) was conducted to investigate the causes, treatment protocols, and mortality rates of US adults with SJS/TEN.

Adverse Effect of Osteoporosis Drug May Help Treat Hair Loss

Researchers found that a non-immunosuppressant drug originally designed to treat osteoporosis (WAY-316606) targeted the same mechanism by antagonizing SFRP1, and after treating hair follicles with WAY-316606 for 6 days, the authors found enhanced human hair growth.

Eskata Now Available to Treat Raised Seborrheic Keratoses

Eskata is a high-concentration hydrogen peroxide-based topical solution intended for in-office application.

Combo Therapy Appears Safe, Effective for Severe Inflammatory Acne

Treatment with the combination gel + oral doxycycline was associated with a 66.2% reduction in inflammatory lesions, a 58.7% reduction in non-inflammatory lesions, and a 62.6% reduction in total lesions at Week 12 vs baseline (P <.0001).

HBV Reactivation Examined in Patients Treated With TNF Antagonists

The authors examined data from 8887 individuals who began TNF antagonist treatment for an autoimmune disease from 2001 through 2010 and were followed through 2012; 52% of these patients were screened for HBV before treatment.

Impoyz Cream Available to Treat Moderate to Severe Plaque Psoriasis

The FDA approval was supported by data from 2 double-blind, randomized, vehicle-controlled trials (N=532) in patients with moderate to severe plaque psoriasis (IGA 3 or 4 and BSA ≥3%).

Risankizumab BLA Submitted for Moderate to Severe Plaque Psoriasis

The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients.

Vaniqa Cream Currently in Shortage

Vaniqa, a hair growth retardant, is indicated to reduce unwanted facial hair in women.

Ilumya Approved for Moderate-to-Severe Plaque Psoriasis

The FDA approval of Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program.

First Herbal Supplement and Topical Duo Launched for Skin Conditions

Both Calm topical and Calm + Detox supplements do not contain any steroids, parabens, sulfates, preservatives, petroleum, tree nuts, and gluten.

FDA Approves the Use of Luzu Cream in Younger Patients

Luzu, an azole antifungal, is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.

Rituxan Granted Priority Review for Rare Autoimmune Disease

The disease can be life threatening. Phase 3 study results released last March demonstrated Rituxan substantialy improved pemphigus vulgaris remission rates and successful tapering.

Oral JAK1 Inhibitor Gets Breakthrough Tx Designation for Atopic Dermatitis

In December, a Phase 3, randomized, double-blind, placebo-controlled trial (JADE) was initiated to evaluate the safety and efficacy of PF-04965842 in 375 patients aged ≥12 years with moderate to severe AD.

FDA Accepts NDA for Plaque Psoriasis Treatment Jemdel

Jemdel, if approved, will be the first high-potency topical steroid for plaque psoriasis with dosing for 8 weeks. The most common adverse event in clinical trials of Jemdel was upper respiratory tract infection.

Topical Nitrates Effective for Treating Raynaud's Phenomenon

A total of 7 trials involving 346 patients were identified; nitroglycerin ointments were used in 4 trials, MQX-503 in 2 trials, and a compounded nitrite in 1 trial.

Cosentyx Labeling Updated to Include Scalp Psoriasis Data

Cosentyx is the first and only fully-human interleukin-17A (IL-17A) antagonist.

New Warnings Added to the Labeling for Kybella

Cases of ulceration and necrosis have been reported with the administration of Kybella following injections that are too superficial.

Potential First-in-Class Treatment Fast-Tracked for Alopecia Areata

Currently, there are no FDA approved treatments for alopecia areata.

Newborn Treated for Toxoplasmosis With Mother's SJS Causative Agents

Stevens-Johnson syndrome is a severe skin reaction often triggered by certain medications.

FDA to Review Seysara for the Treatment of Moderate to Severe Acne

Seysara (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic.

Eskata Approved for Raised Seborrheic Keratoses

The FDA approval was supported by two Phase 3 studies that demonstrated the safety and efficacy of Eskata for the treatment of raised seborrheic keratoses.

FDA Approves New Indication for Xeljanz, Xeljanz XR

The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.

Biosimilar Ixifi Gets FDA Approval for All Remicade Indications

Ixifi is a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor.

New Topical Quinolone Approved for the Treatment of Impetigo

Xepi is indicated for the topical treatment of impetigo due to S. aureus or S. pyogenes in adult and pediatric patients.

Taltz Approved for the Treatment of Active Psoriatic Arthritis

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

FDA Expands Use of DESCRIBE PFD Patch for Laser Treatment of Tattoos

The Patch, which is placed over tattoos prior to removal with a laser, allows physicians to treat tattoos more efficiently by enabling rapid multiple laser passes in a single treatment session.

Phase 3 Results Show Further Efficacy of Novel Plaque Psoriasis Tx

At 16 weeks, 73% of risankizumab patients achieved PSAI 90 vs. 2% of the placebo patients and sPGA 0/1 was reached by 84% of riskanizumab patients vs. 7% of placebo patients (P<0.001).

Impoyz Cream Approved for Moderate to Severe Plaque Psoriasis

Impoyz Cream will be available as a 0.025% cream in 60g and 112g tubes.

Hidradenitis Suppurativa: Pharmacological and Surgical Txs Reviewed

The authors reported significant disability and comorbidities among patients with HS, including obesity, metabolic syndrome, diabetes, and arthritis.

Body Surface Area Affected by Psoriasis May Be Linked to T2DM Risk

To determine the risk of T2DM, researchers compared adults with psoriasis (n=8124), grouping them by affected BSA, to those without psoriasis (n=76,599); patients were followed for ~4 years.

Impact of Psoriasis Treatments on Depressive Symptoms Examined

Psoriasis patients may be at increased risk for depression and suicidality.

Review Investigates Efficacy of Guselkumab for Plaque Psoriasis

In the other Phase 3 trial, transitioning to guselkumab treatment was more effective than continued ustekinumab use in reducing IGA scores in those minimally responsive to ustekinmab.

Physician, Patient Survey Reveals Most Important Attributes of Psoriasis Tx

The study quantifies the importance of clinical attributes of psoriasis therapies that dermatologists and psoriasis patients consider when choosing treatments.

FDA: Serious Injuries With Injectable Silicone Used for Body Contouring

Silicone injections for body contouring are often performed by unlicensed and non-medical practitioners in non-clinical settings such as residential homes or hotels.

FDA Accepts NDA for Topical Combination Treatment for Plaque Psoriasis

The Prescription Drug User Fee Act (PDUFA) action date is June 18, 2018.

Rare Disorder Causes Patient to Spontaneously 'Sweat Blood'

During the patient's admission, a bleeding episode occurred which resulted in blood-stained fluid on her face.

Proton Pump Inhibitor Use Linked to Two Distinct Dermatological Reactions

The case involved a 32-year-old male who was prescribed pantoprazole after initially presenting with dyspepsia-like symptoms.

Alcohol May Contribute to Premature Mortality in Psoriasis Patients

The researchers compared an cohort of patients with psoriasis (≥18 years of age) drawn from several databases to 20 patients without psoriasis who were matched by age, sex, and general practice (n=55,537 and 854,314 respectively).

Safety of Systemic Medications Investigated in Pediatric Psoriasis

Methotrexate was the most commonly used agent (270 patients [69.2%]), followed by biologic agents, primarily etanercept (106 [27.2%]), acitretin (57 [14.6%]), cyclosporine (30 [7.7%]), and fumaric acid esters by (19 [4.9%]). Seventy-three patients (18.7%) used ≥1 medication.

Stelara Approved to Treat Adolescent Patients With Plaque Psoriasis

The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years.

Investigational Hyperhidrosis Therapy Found to Be Safe, Effective

Daily treatment with glycopyrronium tosylate in the Phase 3, open-label ARIDO trial was generally well-tolerated during 44 weeks of treatment.

Botox Approved for Improving Moderate to Severe Forehead Lines

Botox Cosmetic is already approved for the temporary improvement of crow's feet lines and frown lines between the eyebrows in adults.

Test Helps Clinicians Select Appropriate Tx for Suspected Wound Infections

Using a simple swab from the infection site, DxWound uses a special transport buffer that preserves the wound microbiome during transit.

Hair Regrowth in Alopecia Patients After Fecal Transplant for Recurrent CDI

These 2 cases suggests that fecal transplants can have a profound immunological response not only limited to intestinal effects, say the authros.

Dupixent Improves Disease Severity, Skin Clearing in Atopic Dermatitis

The data indicated 59% of patients given Dupixent weekly with topical corticosteroids and 63% of patients given Dupixent every 2 weeks with topical corticosteroids achieved EASI-75 vs. 30% of patients given placebo with topical corticosteroids (P<0.0001).

Tremfya Sustains Long-Term Skin Clearance in Plaque Psoriasis

Patients who were crossed over to Tremfya from Humira showed substantial improvement in PSSD scores from Week 48 to Week 100.

AAP Publish First Guidance on Tattooing, Piercing for Adolescents

These can occur from contamination of the inks or diluents used for tattooing.

Cemiplimab Gains Breakthrough Tx Designation for Advanced Skin Cancer

A Phase 2, single-arm, open-label clinical trial, EMPOWER-CSCC 1, is now enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.

FDA: Do Not Use These Alcohol Pads, Antiseptic Towelettes

These products may not be sterile and may have other quality issues.

EpiCeram Now Available as Quad Pack Airless Pumps

EpiCeram contains a balanced ratio of ceramides, free fatty acids, and cholesterol, which are essential lipids for total skin barrier repair; they mimic the lipid concentration found in the skin.

Psoriatic Arthritis Treatment Trends Investigated

Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.

Nutraseb Available for the Management of Seborrheic Dermatitis

A clinical trial of Promiseb (NCT01214434) found the cream to be safe and significantly efficacious in reducing scaling from baseline to end of treatment when compared with a bland emollient (58%; SD: 62 vs. 90%; SD: 22).

Which Medications Are Prescribed Most Often for Atopic Dermatitis?

Male patients exhibited the highest rates of oral steroid prescriptions.

Low-Dose Naltrexone Effective for Severe Genetic Blistering Disease

Current treatments for Hailey-Hailey disease, a severe genetic blistering disease of intertriginous skin, have led to varied clinical outcomes with potentially severe side effects.

First Interchangeability Study Initiated for Adalimumab Biosimilar

Researchers will compare the pharmacokinetics and clinical outcomes between patients continuously receiving Humira vs. repeatedly switching between Humira and BI 695501.

Biosimilar Renflexis Now Available

Infliximab products work by neutralizing the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibiting the binding of TNF-alpha with its receptors.

Octagam 10% Gains Orphan Drug Status for Rare Muscle, Skin Disorder

Octagam 10% is currently approved to treat chronic immune thrombocytopenic purpura (ITP) in adult patients. It is supplied as 2g, 5g, 10g, or 20g single-use bottles.

Tremfya Approved for Moderate to Severe Plaque Psoriasis

In the NAVIGATE study, 31% of patients treated with Tremfya were considered cleared or almost cleared vs. 14% of patients treated with Stelara (ustekinumab; Janssen Biotech) at Week 28.

FDA Clears At-Home Light Therapy Device for Psoriasis

A clinical trial (Pfaff S et al. 2015) of 47 individuals with mild psoriasis found significant improvement in change from baseline of Local Psoriasis Severity Index in patients receiving UV-free blue light home treatment.

Aquaphor Baby Fast Relief Paste Available for Diaper Rash

Aquaphor Baby Fast Relief Paste is available in 3.5oz (99g) tubes.

Pesticide-Free Lice Treatment Gets FDA Clearance

Resultz is an odorless treatment that kills and removes head lice with a 5 minute application time; this is the shortest time frame associated with currently available lice products.

High-Dose Vitamin D May Benefit Skin After Sunburn

The study found that subjects who took the highest doses of vitamin D had long-term benefits, including reduced skin inflammation 48 hours after the burn.

FDA Expands Dysport Use for Lower Limb Spasticity in Adults

The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury.

Sleep Disorder Treatment Linked to Serious Skin Side Effect

Serious rash, including SJS, is a reported adverse event in the prescribing information for both modafinil and armodafinil.

Tegaderm CHG IV Securement Dressing Reduces Catheter-Related Infections

In the clinical trial, upon catheter removal, there were decreases noted in catheter colonization and skin colonization rates.

Tildrakizumab to Be Reviewed for Moderate-to-Severe Plaque Psoriasis

Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.

Minolira Approved for Moderate to Severe Acne Vulgaris

In 1 of the 2 trials the approval was based on patients in the Minolira group had a 43.1% mean improvement in inflammatory lesions vs. 31.7% of patients in the placebo group.

Xeljanz Under FDA Review for Psoriatic Arthritis

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Adding a Steroid May Not be Necessary in Acute Urticaria Management

Results showed that the placebo group actually had a greater reduction in itch score, with 76% of this group having an itch score of 0 compared to 62% of patients in the prednisone group.

Vitamin D Review Looks at Risk Factors for Deficiency, Treatment Protocols

Protection against skin cancer is important but "moderate levels of unprotected sun exposure can be very helpful in boosting vitamin D."

Mederma Quick Dry Oil and Spezial Collection Launch in U.S.

"As an aesthetics company, we understand that beauty starts from the inside out. With Mederma Spezial, consumers now have the opportunity to impact the health not only of their skin, but of their hair and nails," said Jim Hartman, VP and U.S. Head of Merz Aesthetics Marketing and OTC.

Biosimilar Renflexis Gets FDA Approval

A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.

Rhofade Available for Persistent Redness with Rosacea

Rhofade applied once-daily demonstrated a reduction in persistent facial erythema associated with rosacea through 12 hours in both clinical trials.

Humira Label Updated With Fingernail Psoriasis Data

The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study.

Dupixent Approved for Moderate-to-Severe Atopic Dermatitis

Dupixent, a human monoclonal antibody, works by inhibiting the overactive signaling of IL-4 and IL-13 proteins, which are believed to play a major role in the persistent inflammation in atopic dermatitis.

Sarecycline Promising for Moderate to Severe Acne

Allergan and Paratek announced positive results from two Phase 3 studies of sarecycline for the treatment of moderate to severe acne.

OXY On-The-Go Acne Stick Launched

The new OXY On-The-Go Acne Stick allows teens to spot-treat at any time; it can be used for different skin types.

Rituxan Gets Breakthrough Therapy Status for Rare Autoimmune Skin Disorder

Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.

Juvederm Vollure XC Approved for Facial Wrinkles and Folds

The injectable gel is balanced with firmness and low cohesivity delivering results that last up to 18 months from the initial or touch-up injection.

Alopecia, BPH Treatments Linked to PED

Among those who developed PED, the condition continued for months or years, despite patients stopping treatment.

Study Investigates Transfer of TNFi Therapy to Breast Milk

A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.

Secukinumab Efficacy Examined Following Psoriasis Relapse After Treatment Pause

The new findings come from an uncontrolled extension of two previous secukinumab trials in which patients were re-randomized to placebo following PASI achievement.

NSAID-Hypersensitivity Evaluated in NSAID-Induced Urticaria/Angioedema

Patients confirmed as having NIUA develop tolerance to NSAIDs over time

'On-the-Go' Treatment for Acne Available Soon

Cutanea Life Sciences has announced the availability of Aktipak (erythromycin and benzoyl peroxide) Gel, 3%/5% for the topical treatment of acne vulgaris.

Guselkumab Shows Superiority in Plaque Psoriasis Phase 3 Studies

Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.

Fusidic Acid Looks Promising as Oral Therapy for ABSSSI

The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.

Ustekinumab Effective for Long-Term Remission in Crohn's Disease

Among randomized patients who entered the long-term extension trial period , 79.2% of patients receiving ustekinumab every 12 weeks and 87.1% of patients receiving ustekinumab every 8 weeks were in remission,

FDA Approves Siliq for the Treatment of Plaque Psoriasis

The drug carries a Black Box Warning and is available only through a restricted program.

Psoriasis Outcomes with Ixekizumab Impacted by Interrupted Therapy

Psoriasis patients who interrupted therapy with ixekizumab displayed a reduced level of response.

Facelift Malpractice Litigation Outcomes Analyzed

Most cases of rhytidectomy malpractice litigation are resolved in the defendant's favor, according to research published online February 9 in JAMA Facial Plastic Surgery.

Acne Gel Recalled Due to Presence of Mold

Perrigo announced a recall of 10 lots of Clindamycin Phosphate and Benzoyl Peroxide Gel (1.2%/5%) due to the presence of a small amount of mold on the caps of the tubes.

Common Serum Trace Elements ID'd in Alopecia Areata Patients

Patients with alopecia areata (AA) have significantly lower serum levels of zinc and selenium, according to a meta-analysis published online February 2 in The Journal of Dermatology.

Review of Moisturizer Efficacy in Eczema

Among patients with eczema, most moisturizers showed some benefit but better results were seen when used with topical active treatment, according to a Cochrane Review.

Prescribing Practices for Severe Atopic Dermatitis Vary Greatly Among U.S., Canadian Clinicians

Prescribing practices vary among U.S. and Canadian physicians treating severe childhood atopic dermatitis (AD), according to a study published in the Journal of the American Academy of Dermatology.

Immunotherapy vs. Cryotherapy in Treating Wart Lesions

Intralesional immunotherapy is more effective than cryotherapy for treatment of wart lesions, according to a study published online in the International Journal of Dermatology.

FDA: Life-Threatening Allergic Reactions Linked to Skin Antiseptic

Reactions can occur within minutes of exposure.

New Skin Protectant Available to Prevent Incontinence-Associated Dermatitis

3M announced the launch of Cavilon Advanced Skin Protectant for the prevention of moderate to severe incontinence-associated dermatitis (IAD).