FDA Approvals and News

Raptiva Labeling Gets Boxed Warning

The FDA has approved labeling changes, which include a boxed warning, to highlight the risks of life-threatening infections, such as progressive multifocal leukoencephalopathy, with the use of Genentech’s psoriasis drug efalizumab (Raptiva). The changes are based on the FDA’s postmarket surveillance of efalizumab. The agency also is requiring submission of a risk evaluation and mitigation strategy.

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Medicis Announces FDA Approval of PMA Supplement for Restylane

The FDA has approved its premarket approval application (PMA) supplement, based on clinical data, which highlights Restylane’s duration effect up to 18 months in 97% of patients with repeated treatment. The Restylane package insert will be amended to include the study results. The manufacturer anticipates using this information in its promotional activities.

This randomized, evaluator-blinded, multi-center study enrolled 75 patients to study the safety and effectiveness of two different retreatment schedules, including duration of correction. Following a bilateral (split-face) design, each patient had both nasolabial folds corrected with Restylane. One side of the face was randomly selected to be corrected with Restylane and then re-treated at 4.5 months; the opposite side was re-treated at 9 months. Patients were evaluated using the Wrinkle Severity Rating Scale (WSRS), a five-point scale to measure visual severity of wrinkles where five is the most severe rating (extreme). Patients enrolled in the study had an initial WSRS rating of three (moderate) or four (severe).

The study found Restylane’s effective correction of nasolabial folds persisted for up to 18 months post initial treatment, regardless of retreatment schedule. Most patients (97%) had at least one grade improvement on the WSRS at 18 months when retreated at 4.5 months. The study showed no significant difference between 4.5-month and 9-month retreatment schedules for effectiveness and safety assessment. Adverse events were primarily swelling (24%) and bruising (19%); none were serious.

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Reliant Technologies Announces FDA 510(K) Clearance Of New Handpieces

Reliant Technologies, Inc., announced that it has received FDA 510(k) clearance for three new Fraxel re:pair laser handpieces. These handpieces expand the capabilities of the Fraxel re:pair laser system, providing physicians with a complete skin resurfacing and surgical treatment option. As part of the Fraxel re:pair Complete Fractional Ablative Workstation, all three surgical handpieces can be used either alone or in combination with each other, without turning the system off to change handpieces.

For skin resurfacing, the new Fraxel re:pair 600 micron handpiece performs superficial procedures both on and off the face, including the neck, hands and chest, and treats fine lines, age spots and sun spots. The 600-micron handpiece can treat up to four times faster than any other ablative fractional device and provides a more uniform treatment with better results and faster healing for patients.

The two surgical handpieces include an incisional and ablative handpiece. According to the company, the 0.2-mm Incisional Handpiece provides a safe, effective and reliable alternative to traditional surgical procedures, enabling physicians to perform laser blepharoplasty, vermillionectomy of the lip and excisional procedures such as keloid scar and wart removal. The 2-mm Ablative Handpiece can remove larger sections of soft tissue, enabling physicians to effectively treat a variety of dermatological conditions, including removal of warts, keloids, seborrheic keratoses and actinic keratoses. The company says, the Fraxel re:pair 0.2mm Incisional Handpiece and 2-mm Ablative Handpiece enable precise tissue cutting with minimal damage, resulting in minimal-to-no bleeding and reduced post-operative swelling and bruising, providing patients with a faster healing and recovery time.

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Eisai’s Ontak Gets FDA Approval

The FDA has approved Eisai’s U.S. subsidiary’s sBLA for Ontak injection to treat patients with a rare type of lymphoma that manifests itself on the skin.

The approval is based on data from a Phase III clinical trial that evaluated the overall efficacy and safety of Ontak (denileukin diftitox) to treat patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25).

The randomized, double-blind, placebo-controlled, parallel-group Phase III trial enrolled 144 patients who received either of two doses of Ontak — 18 or 9 mcg/kg per day — or placebo for up to eight cycles of therapy.

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Skin and Aging News and Trends

Skin ‘Odor Profiles’ May Aid Skin Cancer Detection and Diagnosis

According to research described in a press release from The Monell Chemical Senses Center, odors from skin can be used to identify basal cell carcinoma, findings that could lead to the development of new methods to detect basal cell carcinoma and other forms of skin cancer.

Studies

The press release highlighted findings from two studies supported wholly or in part by the Monell Center, a nonprofit basic research institute based in Philadelphia.

In research presented at the recent American Chemical Society meeting, investigators compared profiles of airborne chemical molecules known as volatile organic compounds (VOCs) — many of which are odorous — from basal cell carcinoma sites in 11 patients and compared them to profiles from similar skin sites in 11 healthy controls.

Both profiles contained the same array of chemicals; the difference involved the amounts of specific chemicals – some were increased and others decreased in samples from basal cell carcinoma sites.

To identify changes related to cancer, the researchers first needed to identify a normative profile for VOCs and to determine whether this profile varies as a function of age, gender or body site.

This was the focus of the second study, which sampled air above two skin sites — forearm and upper back — in 25 healthy male and female subjects, who ranged in age from 19 to 79.

Using gas chromatography-mass spectrometry techniques, researchers this time identified almost 100 different chemical compounds coming from skin. The normative skin profile varied between the two body sites, with differences in both the types and concentrations of VOCs.

Aging did not influence the types of VOCs found in the profiles; however, certain chemicals were present in greater amounts in older versus younger subjects.

Implications

“Chemical biomarkers may eventually serve as objective clinical markers of disease if effective sensor technology can be developed,” said Monell analytical organic chemist George Preti, PhD.

The press release surmised that the two studies may help advance development of new methods to analyze skin for signs of altered health status, and that increased understanding of the chemicals related to skin odor could also lead to development of more effective anti-aging skin care products.

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Oral Vitamin D May Help Prevent Some Skin Infections

A study led by Richard Gallo, MD, PhD, and Tissa R. Hata, MD, at the University of California, San Diego School of Medicine suggests that use of oral Vitamin D supplements boosts production of the peptide cathleciden and may help prevent skin infections resulting from atopic dermatitis.

Background and study method and findings

It had previously been shown that defects in the immune system interfere with the skin’s ability to produce the peptide cathelicidin, which is protective against microbial invasion. In many skin diseases, including eczema, a deficiency of cathelicidin correlates with increased infection.

Participants — 14 with atopic dermatitis and 14 without — were all given 4000 IUs of oral vitamin D3 (cholecalciferol) per day for 21 days. Skin lesions were biopsied before and after the 21-day period.

Drs. Gallo and Hata, who are Chief of the Division of Dermatology at the UCSD School of Medicine and the Dermatology section of the Veterans Affairs San Diego Healthcare System, and Associate Professor of Medicine at UC San Diego, respectively, found that oral vitamin D use by the patients appeared to correct the skin’s defect in cathelicidin.

Implications

Noting that the study was a small one, investigators maintain that further research is needed to evaluate the long-term effects of vitamin D supplementation, and to determine if this may be an adequate way to prevent infections in patients with atopic dermatitis.

Their report appears in the Journal of Allergy & Clinical Immunology. (Hata TR et al. Administration of oral vitamin D induces cathelicidin production in atopic individuals. J Allergy Clin Immunol. 2008; 122(4):829-831.)

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HairDX Screening Test Predicts Future Baldness

A simple genetic screening test predicting a man’s likelihood of developing male pattern baldness is now available through physicians.

The test from PharmaGenoma, Inc., and its subsidiary HairDX, LLC, allows the physician to tell a man who tests positive for the high-risk genetic variant that he has approximately a 70% chance of going bald, or one who tests negative for the high-risk genetic variant that he has approximately a 70% chance of not going bald.

According to the manufacturer, the test report is based on a pooled data model from multiple peer-reviewed studies of more than 2,000 Caucasian men. The studies demonstrated the association between the genetic variants measured by the HairDX genetic screening test and the development of androgenetic alopecia in men.

The main advantage of the screening test is its ability to easily identify approximately 70% of men who will benefit from early treatment. As for the men thus identified erroneously, they can avoid unnecessary treatment by obtaining confirmatory tests from a qualified physician.

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New Study Demonstrates Clinical Relevance of Patch Testing for Children

The results of the first U.S. study demonstrating clinical relevance of positive patch tests in children was recently published n the September/October 2008 issue of Pediatric Dermatology. The study, Clinically Relevant Patch Test Reactions in Children — A United States Based Study, found that allergic contact dermatitis in the pediatric population is more common than previously thought, with recent prevalence estimates of positive patch test reactions in the range of 14% to 70% of children patch tested. The aim of the study was to confirm the prevalence of clinically relevant allergic contact dermatitis in children at two referral centers and determine the most common contact allergens. The study authors, Sharon E. Jacob, Bruce Brod and Glen H. Crawford, concluded that the diagnosis of allergic contact dermatitis to specific relevant allergens is common in children referred for patch testing and that contact allergy should be considered in all children with recalcitrant dermatitis.

— Jacob SE, Brod BA, Crawford GH. Clinically relevant patch test reactions in children--a United States based study. Pediatr Dermatol. 2008 Sep-Oct;25(5):520-527.