Dose-Ranging Study of Botulinum Toxin Type A in the Treatment of Glabellar Rhytids in Females

OBJECTIVE: To compare the efficacy, safety, and duration of effect of four doses of botulinum toxin type A in the treatment of glabellar rhytids in females. DESIGN: Double-blind, randomized, parallel-group, dose-ranging trial followed by an open-label extension. SETTING: Private dermatologic clinic. SUBJECTS: Eighty female subjects with moderate to severe wrinkles at maximum frown entered the study. The first 40 subjects completing the double-blind phase entered the open-label extension. INTERVENTION: Random administration of 10, 20, 30, or 40 U botulinum toxin type A in divided doses. Open-label trial: 30 U botulinum toxin type A at the same sites in divided doses. MAIN OUTCOME MEASUREMENTS: Trained observer and subject assessments of wrinkle severity at maximum frown and repose using the Facial Wrinkle Scale (0 = none to 3 = severe), subject satisfaction, and adverse events. Follow-up monthly for up to 1 year postinjection. RESULTS: Relapse rates and responder rates revealed benefits lasting 3 to 6 months or longer. Objectively, 10 U of botulinum toxin type A was significantly less effective than 20, 30, or 40 U. The relapse rate at 4 months was significantly higher in the 10 U group (83%) versus 40, 30, or 20 U (28%, 30%, and 33%, respectively). Subject satisfaction was high in all groups. Duration of effect and response rates were sustained during the open-label extension. Adverse effects were mild and infrequent. CONCLUSION: Twenty to 40 U botulinum toxin type A doses were significantly more effective at reducing glabellar lines than 10 U. Most subjects experienced benefits for 3 to 4 months; some subjects demonstrated effect for up to 12 months.     

Topical vascular endothelial growth factor reverses delayed wound healing secondary to angiogenesis inhibitor administration

The prevention of new blood vessel growth is an increasingly attractive strategy to limit tumor growth. However, it remains unclear whether anti-angiogenesis approaches will impair wound healing, a process thought to be angiogenesis dependent. Results of previous studies differ as to whether angiogenesis inhibitors delay wound healing. We evaluated whether endostatin at tumor-inhibiting doses delayed excisional wound closure. C57/BL6J mice were treated with endostatin or phosphate-buffered solution 3 days prior to the creation of two full-thickness wounds on the dorsum. Endostatin was administered daily until wound closure was complete. A third group received endostatin, but also had daily topical vascular endothelial growth factor applied locally to the wound. Wound area was measured daily and the wounds were analyzed for granulation tissue formation, epithelial gap, and wound vascularity. Endostatin-treated mice showed a significant delay in wound healing. Granulation tissue formation and wound vascularity were significantly decreased, but reepithelialization was not effected. Topical vascular endothelial growth factor application to wounds in endostatin-treated mice resulted in increased granulation tissue formation, increased wound vascularity, and wound closure approaching that of control mice. This study shows that the angiogenesis inhibitor endostatin delays wound healing and that topical vascular endothelial growth factor is effective in counteracting this effect.     

Polarized Light-Emitting Diode Magnification for Optimal Recipient Site Creation during Hair Transplant

Background. For several years, magnification has been used to separate follicular groupings from donor strips to minimize transection of hair follicles. There has been no discussion regarding the use of magnification to create recipient sites to limit transection of existing hair follicles in recipient zones.
Objective. The study was performed to evaluate the role of magnification when creating hundreds or thousands of recipient sites in patients with existing hair.
Methods. A 2× magnified polarized light-emitting diode (LED) for graft and recipient site creation (Syris Scientific, Gray, Maine) was used in 75 consecutive male and female patients. A team of four experienced surgical assistants and the author evaluated the device for graft creation, recipient site creation, and insertion of grafts.
Results. There was no perceived advantage in creating grafts or placing grafts compared with other magnification devices and traditional methods. There was less eye strain and greater ease in creating recipient sites using polarized magnification compared with traditional surgical lights and no magnification.
Conclusion. In an era of medications that slow or stop hair loss, magnification in recipient sites can reduce transection of existing hair follicles in recipient zones, leading to maximum density from a procedure. Further studies are needed to confirm the reduced transection rate of hair follicles and determine the ideal magnification. The use of magnification with LED polarized light in the recipient zone is an important new tool in hair transplant.     

Long-Term Clinical Outcomes Following Treatment of Actinic Keratosis with Imiquimod 5% Cream

BACKGROUND: The results from four phase III, randomized, vehicle-controlled studies showed that imiquimod 5% cream (imiquimod) was safe and effective in the treatment of actinic keratosis (AK). Patients applied imiquimod or vehicle cream to AK lesions on the face or balding scalp, dosing three times per week or two times per week for 16 weeks. OBJECTIVE: To obtain long-term safety follow-up data and estimate AK recurrence in patients who completely cleared their AK lesions in the treatment area at the 8-week post-treatment visit in the phase III studies. METHODS: One hundred forty-six patients from 30 study centers in the United States were evaluated for clinical evidence of AK, and safety data were collected. RESULTS: After a median follow-up period of 16 months, 24.7% (19 of 77) of the patients administered imiquimod three times per week and 42.6% (23 of 54) of the patients administered imiquimod two times per week had a recurrence of AK (the appearance of at least one AK lesion) in the original treatment area. The median number of AK lesions present was one lesion for both patients receiving imiquimod three times and those receiving imiquimod two times per week compared with a median of six lesions at baseline in the combined three times per week and two times per week phase III studies. There were no long-term safety issues, and the skin quality seen in the imiquimod-treated patients at the end of the phase III studies was maintained. CONCLUSION: One and a half years following treatment, imiquimod continued to provide a long-term clinical benefit in a majority of patients who experienced complete clearance of their AK lesions.     

Endogenous Growth Factors as Cosmeceuticals

Background. Research into the pathophysiology of photodamaged skin has revealed correlations with certain aspects of acute and chronic wound healing. In wound healing, growth factors accumulate at the wound site and interact synergistically to initiate and coordinate wound healing.
Objectives. To review the effects of topical growth factors in wound healing and their potential use in treating photodamaged skin.
Methods. A mixture of multiple growth factors derived from human fibroblasts was applied topically to 14 patients twice daily for 60 days to stimulate the remodeling phase of wound healing.
Results. A total of 78.6% of patients with photodamaged skin showed clinical improvement at 60 days. New collagen formation increased by 37%, and epidermal thickening increased by 27%.
Conclusions. These data, as well as other studies of growth factors in wound healing, demonstrate positive cosmetic and clinical outcomes of topical application of growth factors for the treatment of photodamaged skin.
DR. FITZPATRICK IS THE FOUNDER OF SKIN MEDICA AND OWNS STOCK AS WELL AS STOCK OPTIONS.