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1.
Dermatol Surg ; 41 Suppl 1: S67-74, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25548848

ABSTRACT

BACKGROUND: Although millions of aesthetic procedures are performed annually, few patient-reported outcome (PRO) measures have been used in this setting. OBJECTIVE: To evaluate the impact of onabotulinumtoxinA treatment for crow's feet lines (CFL) on relevant psychological variables and self-perception of age/appearance in subgroup populations. MATERIALS AND METHODS: Facial Lines Outcomes (FLO-11) Questionnaire, Self-Perception of Age (SPA), and Subject Global Assessment of Change in CFL (SGA-CFL) were PRO measures administered in 2 Phase 3, double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines (GL). Patient-reported outcome measures were analyzed by subgroups (age, gender, and baseline CFL severity). Subject satisfaction with appearance was also analyzed. RESULTS: Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact (FLO-11 Items 2, 5, and 8) versus placebo at Day 30 (p ≤ .05). OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day 30 (p ≤ .05) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL. Overall, subjects were satisfied with their appearance. CONCLUSION: OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance, attractiveness, tiredness, age, and satisfaction versus placebo. Subjects treated for CFL and GL experienced even greater effects.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Neuromuscular Agents/therapeutic use , Patient Satisfaction , Self Concept , Skin Aging/drug effects , Adult , Double-Blind Method , Eye , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Treatment Outcome
2.
J Cosmet Dermatol ; 9(1): 11-5, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20367667

ABSTRACT

BACKGROUND: A new hyaluronic acid filler containing pre-incorporated 0.3% lidocaine reduces pain and enhances patient comfort. In vitro studies confirm functional equivalence with non-lidocaine-containing products, but only limited data are available on the long-term effects of lidocaine on filler performance in the clinical setting. AIMS: To investigate whether inclusion of lidocaine impacts the longevity of hyaluronic acid fillers. PATIENTS/METHODS: 60 patients with moderate-severe bilateral nasolabial folds received 24 mg/mL hyaluronic acid with pre-incorporated lidocaine or an equivalent product without lidocaine and were followed-up for up to 76 weeks. RESULTS: Significantly better results were found in favor of HA gel with pre-incorporated lidocaine for physician assessment of injection pain and patient pain assessment after injection (both P < 0.001). Long-term follow-up of patients after almost a year showed that 91% (52/57) of patients had no evidence of facial asymmetry, and investigators confirmed lidocaine had no effect on filler longevity. High levels of patient satisfaction and prolonged benefits due to persistence of the product were noted, with those patients needing additional treatment requiring 'top-up' rather than full re-treatment. CONCLUSIONS: The addition of 0.3% lidocaine does not affect product longevity and the small volume required for 'touch-up' also suggests that longevity is maintained.


Subject(s)
Dermatologic Agents/therapeutic use , Hyaluronic Acid/therapeutic use , Lidocaine/therapeutic use , Rejuvenation , Skin Aging/drug effects , Adult , Aged , Dermatologic Agents/administration & dosage , Dermatologic Agents/adverse effects , Dermatologic Agents/pharmacology , Double-Blind Method , Drug Combinations , Europe , Face , Female , Follow-Up Studies , France , Gels , Humans , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/adverse effects , Hyaluronic Acid/pharmacology , Injections, Intradermal , Lidocaine/administration & dosage , Lidocaine/adverse effects , Lidocaine/pharmacology , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Time Factors , Treatment Outcome
3.
J Drugs Dermatol ; 8(3 Suppl): 1-8, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19288692

ABSTRACT

BACKGROUND: Dermicol-P35 is a collagen gel for soft-tissue cosmetic correction. This study evaluated the affects of Dermicol-P35 in patients who underwent lip enhancement. METHODS: This open, multicenter, retrospective data collection study included patients who received an injection of Dermicol-P35 30G to the lip. All patients who had undergone Dermicol-P35 30G lip injections at 3 cosmetic clinics in Europe were identified and evaluated for inclusion in the study. Assessments were conducted by a clinic investigator immediately after the initial injections and after any touch-up injections as well as 4 months to 10 months after the initial injection. Efficacy measures included subjective impression of improvement by the clinic investigator who performed the injections, and subjective satisfaction of both the investigator and patient with treatment. Safety measures included any adverse events, and the occurrence of swelling, bruising, lumpiness, and pain. RESULTS: Fifty-seven patients were identified to have undergone lip injections, and 51 of these patients met criteria for inclusion in the study. Four months to 10 months postinjection, most patients (98%) were believed to have an improvement in lip enhancement, and the clinic investigators rated themselves as "very satisfied" or "satisfied" with 90% of the treatment results. The majority of patients (94%) were either "very satisfied" or "satisfied" with the Dermicol-P35 30G enhancement. The majority of treatments elicited no reports of swelling, bruising, or lumpiness. CONCLUSION: These study results support Dermicol-P35 30G treatment as a safe and effective treatment for lip enhancement.


Subject(s)
Collagen/administration & dosage , Cosmetic Techniques , Cross-Linking Reagents/administration & dosage , Gels/administration & dosage , Lip/surgery , Ribose/administration & dosage , Adult , Animals , Collagen/chemistry , Cosmetic Techniques/adverse effects , Cross-Linking Reagents/chemistry , Female , Gels/chemistry , Humans , Injections, Subcutaneous , Male , Middle Aged , Patient Satisfaction , Retrospective Studies , Ribose/chemistry , Swine , Time Factors , Treatment Outcome
4.
J Cosmet Laser Ther ; 10(2): 87-92, 2008 Jun.
Article in English | MEDLINE | ID: mdl-18569261

ABSTRACT

BACKGROUND: The clinical characteristics of botulinum toxin type A (BoNTA) depend on the formulation used. OBJECTIVE: To evaluate whether switching BoNTA formulations affects patient satisfaction. METHODS: Forty patients enrolled and all were satisfied or extremely satisfied with Allergan BoNTA (BoNTA-Allergan) treatment in the glabellar+/-crow's feet+/-forehead area(s) in the preceding 6 months. Once improvement from this previous treatment had started to diminish, treatment was replicated using Ipsen BoNTA (BoNTA-Ipsen) at a 1:2.5 dose ratio. RESULTS: The incidence of patients rating treatment as effective or very effective in making them look younger, look rested, and look less stressed was significantly higher with BoNTA-Allergan than BoNTA-Ipsen--83% versus 36%, 90% versus 39%, and 83% versus 33%, respectively--even though evaluations were performed a mean of 20 weeks after BoNTA-Allergan treatment and only 16 weeks after BoNTA-Ipsen treatment. The incidence of patients who were satisfied or extremely satisfied was 100% (BoNTA-Allergan) versus 31% (BoNTA-Ipsen). BoNTA-Allergan was preferred by 69% of patients. CONCLUSIONS: Efficacy, satisfaction, and product preference ratings strongly favor the use of BoNTA-Allergan over BoNTA-Ipsen in the treatment of upper facial lines. Many patients who are satisfied with BoNTA-Allergan treatment become less satisfied if they are switched to BoNTA-Ipsen.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cosmetic Techniques , Patient Satisfaction , Skin Aging/drug effects , Adult , Cross-Over Studies , Female , Humans , Male , Middle Aged
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