Multicenter study for the evaluation of tolerance and efficacy of a new integrated aminoacidic treatment on the aging faceintradermal implant (intermediate visit, T1) andat the end of the study <strong>per</strong>iod (final visit, T4,four months after the last intradermal implant).Clinical evaluationsThe tolerance of the study treatmentwas evaluated by recording and monitoring anyadverse event and by dermatological assessmentof objective symptoms as erythema, oedema,papules, pustules or other symptoms at baselineand on each successive visit. During thevisits the following clinical evaluations (visualscore) were <strong>per</strong>formed on the right or left faceside, according to a previously completed randomizationlist: skin roughness (at the level ofnasolabial folds and <strong>per</strong>iocular area accordingto reference photographic scales, skin smoothness(surface microrelief), skin tonicity and skinbrightness. The efficacy of the study treatmentwas assessed by visual evaluation conducted atbaseline, at T1 and at the end of the study.Wrinkles grade (at the level of nasolabial foldsand in the area around the eyes) was determinedusing a reference clinical and photographicscale (0= no wrinkles, 1= very mild, 2= mild, 3=quite evident, 4= evident, 5= very evident, 6=marked, 7= very marked. 0, 1 and 7 are exclusioncriteria). Surface microrelief evaluation was<strong>per</strong>formed according to a cheek surface photographicscale (1= very regular, 2= regular, 3=irregular, 4= very irregular). Skin tone and skinbrightness were evaluated using a visual score(0= very mild, 1= mild, 2= medium, 3=marked, 4= very marked for skin tone and 1=very opaque, 2= opaque, 3= normal, 4= luminousfor skin brightness).At the end of the treatment (final visit) eachvolunteer gave her <strong>per</strong>sonal judgment on theefficacy of the study treatment on deep andsu<strong>per</strong>ficial wrinkles, as well as on elasticity,smoothness and brightness of the skin.In this pa<strong>per</strong>, we have arbitrarily decided todefine as antiageing activity on the face the possiblepositive influence on skin aging evaluatedand measured locally through any eventualimprovement in the thickness of nasolabialskin folds, as described in I n s t ru m e n t a lEvaluations.Instrumental evaluationsA part of the enrolled subjects (n= 21)was also submitted to instrumental evaluationsusing the optical profilometry technique previouslydescribed in the literature (12-14).These subjects were also administered an additionalintradermal injection at T4 and were reevaluatedat T6 months. At baseline and subsequentvisits (T1 and T4) skin replicas at thelevel of nasolabial folds were taken (right or leftside, according to a randomization list).Replicas were obtained using silicone rubber(Optosil, Heraeus Kulzer GmbH & Co, KG) andallowed the evaluation of the dimension of thewrinkles by computerised image analysis.Image analysis of the replicas (optical profilometry):this evaluation was conducted througha computerised image elaboration (Image ProPlus, Media Cybernetics Inc., USA). Replicas wereilluminated with a 45° incident light, whichcreates shadows behind crests that can be photographed,digitised and analysed. The shadowswere transformed into a grey scale, where greyintensities were directly proportional to shadowintensities and therefore to wrinkle depth.Shadows were detected by thresholding. Bydefining an area within the image, and by tracinga segment of known length in a definedposition across the wrinkle and <strong>per</strong>pendicularto it, it was possible to calculate the followingprofilometric roughness parameters:R a= roughness average parameter which is thearithmetic mean of all ordinates from the meanline of the profile.R t= maximal depth of wrinkles.At baseline (T0), T1, T4 and T6 frontal and profilestandard pictures of the 21 volunteers werealso taken.Self-evaluationsDuring the final visit, each volunteerfilled in a questionnaire regarding the efficacy ofthe treatment under study on deep and su<strong>per</strong>ficialwrinkles, as well as on the elasticity,smoothness and brightness of the skin of theirfaces (using the same score for each item: verymarked; marked; medium; mild; absent).Statistical analysis of dataThe statistical evaluations of the visualand instrumental data (adjusted means andstandard deviation) and their relative graphswere <strong>per</strong>formed at the times required by theprotocol.The statistical analyses of the clinical and selfevaluationdata were <strong>per</strong>formed using theWilcoxon and Friedman tests. The analysis ofall parametric data was done using the Student’st test.Journal of Plastic Dermatology <strong>2007</strong>; 3, 321
A. Sparavigna A, R. Forte, F.S. DioguardiFigure 1.R esultsClinical evaluationsTo l e r a n c e - The tolerance of thetested products was judged as very good and noadverse event occurred during the study <strong>per</strong>iod(final investigators’ opinion: 81%= excellent,18%= good).The good tolerance was confirmed by thevolunteers’ opinion; as a matter of fact, only fewsubjects underlined the appearance of a slighterythema with a burning sensation followingthe first cream and/or liquid patch applicationand lasting few minutes.Clinical evaluations <strong>per</strong>formed during the entiretreatment <strong>per</strong>iod demonstrated the absenceof relevant clinical signs as erythema, oedema,papules, pustules or the like.Clinical evaluation of efficacy - The evaluationof the efficacy of the treatment under studytook into account the above mentioned agingsigns. An example of treatment efficacy isshown in F i g u re 1. The statistical evaluation ofthe clinical data was <strong>per</strong>formed using theWilcoxon test. One month after the last intradermalimplant (T1), a significant and importantimprovement of nasolabial folds (p
- Page 1: Vol. 3, n. 3, September-December 20
- Page 4: L’istopatologia ed il foto-invecc
- Page 10: P. Filecciaammesso nelle formulazio
- Page 13: A. Sparavigna A, R. Forte, F.S. Dio
- Page 17 and 18: A. Sparavigna A, R. Forte, F.S. Dio
- Page 20 and 21: M. Cavallini, M. Papagnitaining lon
- Page 22 and 23: M. Cavallini, M. PapagniSkin hydrat
- Page 24 and 25: M. Cavallini, M. Papagni5. Altman D
- Page 26 and 27: G. Menchini, C. ComacchiM ethodsO b
- Page 28 and 29: G. Menchini, C. Comacchimentation,
- Page 30 and 31: Impiego di lamine autoadesivedi pol
- Page 32 and 33: Impiego di lamine autoadesive di po
- Page 34 and 35: Impiego di lamine autoadesive di po
- Page 36 and 37: Efficacia, tollerabilità ed accett
- Page 38 and 39: Efficacia, tollerabilità ed accett
- Page 40 and 41: Efficacia, tollerabilità ed accett
- Page 42 and 43: D. AnconaGli studi sulla citotossic
- Page 44 and 45: D. AnconaPRIMADOPOFigura 2. Pazient
- Page 46 and 47: L.Scuderi, L. Francesconi, F. Dinot
- Page 48 and 49: L.Scuderi, L. Francesconi, F. Dinot
- Page 50 and 51: E. Perosino12Figura 1.Lesione macul
- Page 52 and 53: Irsutismo:trattamento con eflorniti
- Page 54 and 55: Irsutismo: trattamento con eflornit
- Page 56 and 57: Irsutismo: trattamento con eflornit
- Page 58 and 59: Irsutismo: trattamento con eflornit
- Page 60 and 61: Irsutismo: trattamento con eflornit
- Page 62 and 63: Irsutismo: trattamento con eflornit
- Page 64 and 65:
Una molecola classicain una nuova v
- Page 66 and 67:
Microcircolo, cute e antocianosidiA
- Page 68 and 69:
Microcircolo, cute e antocianosidiL
- Page 70 and 71:
Microcircolo, cute e antocianosidiG
- Page 72 and 73:
Microcircolo, cute e antocianosidiC
- Page 78:
struzioni agli AutoriIObiettivo del