Editor-in-Chief (US) Alan Menter And Therapy
2013Issue 1Editor-in-Chief (US)Alan MenterEditor-in-Chief (EU)Richard WarrenDermatologyand TherapyResearch, treatment and aesthetic intervention in nical research
Original ResearchClinical Efficacy of a Cosmetic Treatment by Crescina Human Follicle Stem Cells on HealthyMales with Androgenetic AlopeciaEditors-in-ChiefUSA: Alan Menter, Baylor University Medical Center, Dallas, TX, USAEurope: Richard Warren, University of Manchester, Manchester, UKEditorial BoardMatthias Augustin, Hamburg, GermanyRobert Baran, Cannes, FranceLasse Braathan, Bern, SwitzerlandMichael Gold, Nashville, TN, USAWayne Gulliver, St. John's, Newfoundland, CanadaAdam Katz, Charlottesville, VA, USAPeter van de Kerkhof, Nijmegen, The NetherlandsAida Khaled, Tunis, TunisiaHans Korting, Munich, GermanyNicholas J. Lowe, London, UKRolf Markus-Szeimes, Regensburg, GermanyTatjana Pavicic, Munich, GermanyMarco Romanelli, Pisa, ItalyRicardo Romiti, Sao Paulo, BrazilGail Todd, Cape Town, South AfricaSkaidra Valiukeviciene, Kaunas, LithuaniaGuy Webster, Philadelphia, PA, USAMichael Wilk, Nuremburg, Germany
Dermatol Ther (Heidelb)DOI 10.1007/s13555-013-0021-2ORIGINAL RESEARCHClinical Efficacy of a Cosmetic Treatmentby Crescina Human Follicle Stem Cell on HealthyMales with Androgenetic AlopeciaDaniela Buonocore Vincenzo Nobile Angela Michelotti Fulvio MarzaticoTo view enhanced content go to www.dermtherapy-open.comReceived: December 19, 2012Ó The Author(s) 2013. This article is published with open access at Springerlink.comABSTRACTpromoting hair growth and in decreasing hairIntroduction: Androgenetic alopecia (AGA) isloss.Methods: Athe most common cause of hair loss amongtrialmales, characterized by progressive thinning ofthe scalp hairs and defined by various patterns.suffering from alopecia grade II to IV. Anagenrate and hair resistance to traction (pull test)The main factors underling hair loss in AGA aregenetic predisposition and increased sensitivitywere assessed after 2 and 4 months of treatmentusing phototricogram and pull test technique.of the hair follicles to androgens, leading to aResults: CrescinaÒ HFSC applied for 4 monthsshortening of the anagen phase. In the presentstudy, the authors investigated the efficacy ofwas effective in promoting hair growth and indecreasing hair loss. After 2 and 4 months ofa commercially available cosmetic lotion,CrescinaÒ HFSC (human follicle stem cell;treatment, the anagen rate was increased by 6.8%and 10.7%, respectively. Hair resistance to tractionLabo Cosprophar AG, Basel, Switzerland), inwas decreased by 29.6% and 46.8%, respectively.D. Buonocore (&) F. MarzaticoLaboratory of Pharmaco-Biochemistry, Nutritionand Nutraceutical of Wellness, Department ofBiology and Biotechnology ‘‘L. Spallanzani,’’,University of Pavia, via Ferrata 9, 27100 Pavia, Italye-mail: farmbio@unipv.itV. Nobile A. MichelottiFarcoderm Srl European Expertise Network forWellness and Dermatology, via Mons. Angelini 21,27028 San Martino Siccomario, Pavia, ealthymalesConclusions: The present study demonstratedthe positive effect of CrescinaÒ HFSC inmodulating the activity of the hair follicle andpromoting hair growth.Keywords: Anagenrate;Androgeneticalopecia; Cosmetics; CrescinaÒ HFSC; Hairgrowth; Hair loss; Pull test; Topical applicationINTRODUCTIONEnhanced content for this article isavailable on the journal web site:www.dermtherapy-open.comAndrogenetic alopecia (AGA) is the mostcommon cause of hair loss among males [1].123
Dermatol Ther (Heidelb)It is characterized by progressive thinning ofhair follicle stem cells to progenitor cells in baldthe scalp hairs, defined by various patternsscalp biopsies from AGA individuals. This[2], which can start at any age after pubertyand is potentially reversible. Even if from afinding is consistent with the current clinicalconcept that AGA is a nonscarring type ofmedical point of view, AGA is considered arelatively mild condition; however, peoplealopecia and suggests potential reversibility ofthe condition.suffering from this condition consider AGA aCurrently, only two medications, based onserious condition that impacts their selfesteem, well-being, social relationships, andfinasterideandminoxidilasactivepharmacological ingredients, are approved byconfidence.The main factors underling hair loss in AGAthe US Food and Drug Administration (FDA) forAGA treatment. However, they are costly, requireareincreasedlifelong treatment, and may have side effects.sensitivity of the hair follicles to androgens[3]. AGA is often precipitated and exacerbatedFurthermore, people are frequently reluctant/intimidated by the pharmacological approachby conditions that can induce telogeneffluvium, including drugs, acute stressors, andto treat a disease that is not life threatening. Thus,atopical,nonpharmacological,effectiveweight loss [4]. However, in recent years itcosmetic treatment could be more acceptable tohas been shown that other factors, suchasmicroinflammation[5],decreasedpatients.The aim of the present study was to assessmicrocirculation [6], and aging [7], can causehair loss in AGA. These changes contribute tothe efficacy of the use of a patented (US6,479,059 B2 and CH 703 390), topicalshifting the normal balance of the hair cycleleading to a shortening of the anagen phase.cosmetic product, CrescinaÒ HFSC (humanfollicle stem cell; Labo Cosprophar AG, Basel,The major components of balding in AGA areSwitzerland), claimed to be effective for thefrontotemporal recession and loss of hair overthe vertex. Hairs become shorter and finer, andtreatment of male AGA [10]. The activeingredients contained in the product werefinally complete hair loss occurs except at thelateral and posterior margins of scalp, wherechosen to obtain three main effects:proliferation of the stem cells of both thehair is retained.bulge and the dermal papilla, keratinization,Histologically, in AGA large terminal folliclesdiminish in size during hair cycles, and theand stimulation of microcirculation. Stem celland dermal papilla stem cell proliferation wasresulting miniaturized follicle eventuallyproduces a microscopic hair. Testosterone isachieved by hydrolyzed rice protein andcorosolic acid, respectively. Keratinization wasnecessary for miniaturization, and econversion of testosterone to its more activeglycoprotein (lectin). Microcirculationstimulatedbybenzylnicotinate.form dihydrotestosterone (DHT), delay theprogression of AGA [8]. Recently, Garza andmentioned results were obtained from studiescommissionedbythecompanyLabocoworkers [9] reported the preservation of stemCosprophar AG, which has filed a patent (CHcell population and a decreased conversion of703 390 B1) andawasThe
Dermatol Ther (Heidelb)MATERIALS AND METHODSAll the study procedures were carried outaccording to World Medical ments (Ethical Principles for MedicalResearch Involving Human Subjects, adoptedby the 18th WMA General Assembly Helsinki,Finland, June 1964 and amendments). Toparticipate in the study, each participant wasfully informed on study risks and benefits, aims,and procedures. An informed consent form anda consent release for publication of photos weresigned by the subject prior to participating inthe study.Subjects and Study DesignHealthy male volunteers suffering from alopeciagrade II to IV according to the Hamilton–Fig. 1 Hamilton–Norwood classificationNorwood scale [11] (Fig. 1) were enrolled inthe study. Subjects were enrolled in the study byTested Producta certified dermatologist if they fulfilled theThe tested product is a commercially availablecosmetic lotion named CrescinaÒ HFSC. Theinclusion and exclusion criteria laid down inthe study design (Table 1) were applicable.Clinical examination was carried out in orderto evaluate the degree and pattern of hair loss,and hair (length, diameter, and breakage) andscalp (inflammation, erythema and, scaling)conditions. Active and placebo treatmentswere then allocated by means of the Efron’sbiased coin algorithm using PASS 11 (versioningredients of the tested product and placeboare listed in Table 2.PhototricogramA transitional area of hair loss between normalhair and the balding area of 1.8 cm2 was defined11.0.8 for Windows; PASS, LLC., Kaysville, UT,using a stencil template and chosen forclipping. The clipped hairs within the targetUSA). The tested and the placebo products wereused for 4 months according to the followingarea were dyed for gray or fair hairs with acommercially available solution (RefectoCilÒ,procedure: apply one vial (5 mL) of the producton clean and dry scalp, line by line,GW Cosmetics GmbH, Leopoldsdorf, Germany)concentrating on the areas where thinning isin order to enhance their contrast. Thereafter,the dyed hairs were cleansed using an alcoholicmore evident; massage gently to aidpenetration; apply every day for 5 consecutivesolution and digital images were taken whilethe area was still wet with a digital close-updays, stop the treatment for 2 days and thencontinue the ly after clipping, and 2 days after123
Dermatol Ther (Heidelb)Table 1 Inclusion and exclusion criteriaInclusion criteriaHealthy male subjectsAge between 20–55 years oldType: Caucasian raceSubjects showing clinical signs of androgenetic alopecia type II–IVSubjects who have not used antihair loss treatments the 6 months before the study startPromise to not use topical and/or systemic products with similar effect to that one of the product to be testedthroughout the study periodPromise to not change the daily routineExclusion criteriaSubjects who do not fit the inclusion criteriaSubjects with allergies or sensitivity to cosmetic products, toiletries, sunscreens and/or topical drugsDisorder of the scalpSubjects with dermatological problems on the test areaSubjects under pharmacological treatment (both locally or systemically)Positive anamnesis for atopyTable 2 Ingredient INCI listings of formulations investigatedFormulation A: test active ingredientsFormulation B: placebo controlAlcohol denat., aqua, glycerin, butylene glycol, lysinehydrochloride, benzyl nicotinate,acetyl cysteine, benzophenone-4, disodium EDTA,glycyrrhetinic acid, menthol,sodium hydroxide, silanediol salicylate,triethanolamine, serine, threonine, propyleneglycol, adenosine, allantoin, zinc acetylmethionate,hematite extract, hydrolyzed riceprotein, phosphatidylcholine, hydrolyzed soyprotein, hydrolyzed DNA, hydrolyzedMA, Eriobotrya japonica leaf extract, salicylic acid,glycogen, glycoproteins, Artemiaextract, C.I. 14720, C.I. 16255, C.I. 19140, C.I.28440, C.I. 73015Alcohol denat., aqua, disodium EDTA, sodium hydroxide, C.I.14720, C.I. 16255, C.I. 19140, C.I. 28440EDTA ethylenediaminetetraacetic acid, INCI International Nomenclature of Cosmetic Ingredientsclipping. These two photographs were thenexamined by a software system that is able tophotographs.Bycomparingthetwophotographs, the computer can determinerecognizewhich hairs are growing (anagen hairs) and123individualhairfibersinthe
Dermatol Ther (Heidelb)which are not (telogen hairs). The samemean standard deviation (SD). P\0.05 wasprocedureconsidered significant.wascarriedoutafter2and4 months of treatment.Pull TestGentle traction was exerted on a cluster of hairs(approximately 60 hairs) on at least threeRESULTSForty-six healthy male volunteers (Table 3)suffering from alopecia grade II to IV wereenrolled in the study.different areas of the scalp, and the number ofextracted hairs was counted. Normally, lessthan three telogen-phase hairs should comeAnagenout with each pull [12]. If at least three hairswere obtained with each pull or if more thanThe results of anagen hair rates (as %) at baselineten hairs total were obtained, the pull test was(T0), 2 (T2), and 4 (T4) months are reported inTable 4 and Fig. 2. Baseline mean anagen hair rateconsidered positive and suggestive of telogeneffluvium.was similar between active (63.8 4.2%) andplacebo (62.8 4.3%) groups, and notstatisticallysignificant(P[0.05).AttheGlobal Photographic Assessment2 months follow-up, only the active productgroup demonstrated a statistically significantPatients were asked to maintain the same hairimprovement of anagen hair rate (70.6 6.9%);while in the placebo (63.7 5.0%) group nostyle, color, and length throughout the study.Standardized global photographs of the frontal/parietal region were taken using a digital cameraequipped with a macro lens.changes were observed. At 4 months, the activeproduct group showed an additional statisticallysignificant increment of the mean anagen rate(74.5 5.6%). A slight statistical improvementStatistical AnalysisAn intention to treat statistical analysis wasperformed using NCSS 8 (version 8.0.4 forTable 3 Baseline characteristics of the randomizedsubjectsCrescina HFSC(n 5 23)Windows; NCCS, LLC., Kaysville, UT, USA).Placebo(n 5 23)Data were checked for normality using eitherthe Shapiro–Wilk W, Kolmogorov–Smirnov,Mean age SD, years34.7 11.2and D’Agostino omnibus normality tests. Ifthe data were normal, the repeated measureMean baseline anagenratio SD63.8 4.2% 62.8 4.3%analysis of variance (RM-ANOVA) followed byHamilton–Norwood score,no. (%) of individualsTukey–Kramer multiple comparison test wasperformed both for intra- and inter-groupcomparisons. If data were not normal, theWilcoxon signed-rank test was performed forintra-group comparisons, whereas the Mann–Whitney U test was performed for inter-groupcomparisons. Values are expressed as arithmeticType II5 (21.7)5 (21.7)Type III10 (43.5)11 (47.8)Type III vertex5 (21.7)4 (17.4)Type IV3 (13.0)3 (13.0)HFSC human follicle stem cell, SD standard deviation123
Dermatol Ther (Heidelb)Table 4 Results of anagen hair count (%)Active productnMean(–SD)Placebo product1stquartileMedian 3rdquartilenT 0 months 23 63.8 4.262.464.367.4T 2 months 23 70.6 6.965.869.1T 4 months 23 74.5 5.669.873.9Mean(–SD)1stquartileMedian 3rdquartile23 62.8 4.359.462.266.776.923 63.7 5.059.962.565.977.723 65.0 5.260.864.569.4SD standard deviationwas also seen in the placebo group (65.0 5.2%).The variation versus T0 (Fig. 3) of the anagen hairrate in the active product group was ?6.8 and?10.7% after 2 and 4 months, respectively;whereas an improvement of ?2.2% was seen inthe placebo group only at 4 months. Statisticalanalysis of the mean anagen rate in the activegroup showed a time-dependent statisticallysignificant improvement (P\0.001); whereas inthe placebo group, time was a source of variationonly at 4 months (P 0.004). Analysis of the meananagen rate between the active group compared tothe placebo group was also statistically significant(P\0.001). The improvement of anagen rate inthe active group was observed in 95.7% (at T2) and100% (at T4) of the subjects participating in thetrial; whereas in the placebo group it was seen inFig. 2 Anagen rate (%) variation during the treatment.*P\0.05 versus T0, **P\0.001 active treatment versusplacebo, ***P\0.001 versus T0. T0 baseline, T22 months, T4 4 months56.5% (at T2) and 69.6% (at T4).Pull TestThe results of pull testing at baseline, 2, and4 months are reported in Table 5 and Fig. 4.Baseline mean pulled hairs in the pull test wassimilar between the active (9.2 1.3) and placebo(9.1 1.8) groups, which was not statisticallysignificant (P[0.05). At the 2 months follow-up,only the active product group demonstrated astatistically significant improvement of 29.6% ofhair resistance to traction (6.4 1.8); whereas inthe placebo (8.3 2.1) group no changes wereobserved. At 4 months, the active product group123Fig. 3 Improvement of anagen rate (%) after the treatment. Data are reported as mean SD. SD standarddeviation, T0 baseline
Dermatol Ther (Heidelb)Table 5 Results of pull testingActive productnMean(–SD)Placebo product1stquartileMedian 3rdquartilenT 0 months 19 9.2 1.38910T 2 months 19 6.4 1.856T 4 months 19 4.8 1.545Mean(–SD)1stquartileMedian 3rdquartile18 9.1 1.88910818 8.3 2.17810618 7.6 1.9689SD standard deviationshowed an additional statistically significantincrement of 46.8% of hair resistance(4.8 1.5). A slight statistical improvement of16.6% was also seen in the placebo group(7.6 1.9). Statistical analysis of the meananagen rate in the active group showed a timedependent statistically significant improvement(P\0.001); whereas in the placebo group, timewas a source of variation only at 4 months(P 0.044). Analysis of the hair fall in the hairpull test between the active group compared tothe placebo group was also statistically significant(P\0.01 and P\0.001 at T2 and T4,respectively). The improvement of hairresistance to traction in the active group wasobserved in 89.5% (at T2) and 100% (at T4) of thesubjects participating in the trial; whereas in theplacebo group it was seen in 52.6% (at T2) andFig. 4 Resistance to traction (pull testing) variationduring the treatment. *P\0.05 versus T0, **P\0.01active treatment versus placebo, ***P\0.001 versus T0,****P\0.001 active treatment versus placebo. T0 baseline,T2 2 months, T4 4 months78.9% (at T4).the subject [1]. The pharmacologic treatment ofAGA is expensive, requires lifelong treatment,Global Photographic Assessmentand may have side effects. Subjects are alsoFigure 5 shows the macroscopic effect of theproduct on hair growth. An increase in hairreluctant/intimidated to use drugs for anonpathologic condition; however, use ofgrowth was seen in the frontal and parietal areacosmetics is more acceptable.A large number of cosmetics claiming to be(vertex) of the scalp.effective in the coadjuvant treatment of AGADISCUSSIONare sold on the market, but some lack proof ofeffect, relying only on the effects of the rawAndrogenetic alopecia is the most commonmaterials. Contrary to this approach, newcosmetic regulations [13] require manufacturescause of hair loss among males and has ato demonstrate product efficacy in order topsychosociologic impact on the well-being ofprotect subjects from misleading claims.123
Dermatol Ther (Heidelb)Fig. 5 Digital photography. T0 baseline, T4 4 months (a–c)123
Dermatol Ther (Heidelb)Fig. 5 continuedThe present study aimed to assess theefficacy of the topical application of cysteine,further expand these data by considering agreater sample size and longer-term study.lysine, a glycoprotein, hydrolyzed rice protein,In conclusion, the present investigation hasand corosolic acid (the active ingredients thatare contained in the formulation of CrescinaÒdemonstrated the effects of a mixture ofingredients that is able to promote hair growthHFSC) in promoting hair growth and indecreasing hair loss [10]. It would be desirableand decrease hair loss. The results obtainedshowed that CrescinaÒ HFSC applied forto analyze a larger population sample; however,4 months in subjects suffering from alopeciathis would require longer-term studies(approximately 1 year), which are not alwaysgrade II to IV was effective in stimulating hairfollicle activity as demonstrated by the time-compatible with the needs of the economiccommitment of research and the y, the treatment decreased hairmarket,loss and hair resistance to traction, . Moreover, the compliance of largegroups of subjects who undergo the testdecreases with time spent in the clinical trials.On this basis, as the present study has alreadyits beneficial effect on hair loss.ACKNOWLEDGMENTSshown efficacy in the short term (4 months), itwas considered significant and important tohighlight this positive result. The authors canThe authors thank the staff of Farcoderm fortheir professionalism and support during study123
Dermatol Ther (Heidelb)development. The performance of the study wassponsored by Labo Cosprophar AG, Basel,Switzerland. The sponsor had no influence inthe performance, analysis, and interpretation ofthe study. Dr. Marzatico is the guarantor for thisarticle, and takes responsibility for the integrity4.Gordon KA, Tosti A. Alopecia: evaluation andtreatment. Clin Cosmet Investig Dermatol. 2011;4:101–6.5.Mahe YF, Michelet JF, Billoni N, et al. Androgeneticalopecia and microinflammation. Int J Dermatol.2000;39:576–84.6.Hernandez BA. Is androgenic alopecia a result ofendocrine effects on the vasculature? MedHypotheses. 2004;62:438–41.7.Kligman AM. The comparative histopathology ofmale-pattern baldness and senescent baldness. ClinDermatol. 1988;6:108–18.8.Paus R, Cotsarelis G. The biology of hair follicles.N Engl J Med. 1999;341:491–7.9.Garza LA, Yang CC, Zhao T, et al. Bald scalp in menwith androgenetic alopecia retains hair follicle stemcells but lacks CD200-rich and CD34-positive hairfollicle progenitor cells. J Clin Invest. 2011;121:613–22.of the work as a whole.Conflict of interest. Dr. Buonocore declaresno conflict of interest. Dr. Nobile declares noconflict of interest. Dr. Michelotti declaresno conflict of interest. Dr. Marzatico declaresno conflict of interest.Open Access. This article is distributedunder the terms of the Creative CommonsAttribution Noncommercial License whichpermits any noncommercial use, distribution,and reproduction in any medium, provided the10. Report patent document filed on January 13, 2012in Zurich (CH) representative Schmauder & PartnerAG Patent- und Markenanwalte VSP, Zurich.original author(s) and the source are credited.11. Norwood OT. Male pattern baldness: classificationand incidence. South Med J. 1975;68:1359–65.REFERENCES1.Springer K, Brown M, Stulberg DL. Common hairloss disorders. Am Fam Physician. 2003;68:93–102.2.Trueb RM. Molecular mechanism of androgeneticalopecia. Exp Gerontol. 2002;37:981–90.3.Blume-Peytavi U. Anlagebedingter Haarausfall undaktuelle Therapiekonzepte. Akt Dermatol. 2002;28(Suppl. 1):19–23 (in German).12312. Harrison S, Bergfeld W. Diffuse hair loss: its triggersand management. Clevel Clin J Med. 2009;76:361–7.13. Regulation (EC) no 1223/2009 of the EuropeanParliament and of the Council of 30 November2009 on cosmetic products. Official Journal of theEuropean Union. 2009; L342/59.
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