Combined effects of glycerol and petrolatum in an emollient cream: A randomized, double-blind, crossover study in healthy volunteers with dry skin.
Adult
Cross-Over Studies
Double-Blind Method
Drug Combinations
Emollients
/ administration & dosage
Epidermis
/ drug effects
Female
Glycerol
/ administration & dosage
Healthy Volunteers
Humans
Male
Paraffin
/ administration & dosage
Skin Cream
/ administration & dosage
Treatment Outcome
Water Loss, Insensible
/ drug effects
Trans Epidermal Water Loss
corneometry
emollient
skin barrier function
skin hydration
Journal
Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
27
06
2019
revised:
03
09
2019
accepted:
05
09
2019
pubmed:
19
9
2019
medline:
9
2
2021
entrez:
19
9
2019
Statut:
ppublish
Résumé
The stratum corneum plays an important protective physiological role in providing a barrier to preventing skin desiccation and penetration of external agents. Emollients are used commonly to improve barrier function and skin hydration. The primary objective of this study was to evaluate the effect of an emollient, V0034CR cream, and its active ingredients, to restore the cutaneous barrier. Secondary objectives included assessment of the moisturizing activity of each product and tolerance. The study was not designed to evaluate therapeutic benefit. In this randomized, double-blind, 4-arm crossover, clinical pharmacology study, the full emollient V0034CR, its vehicle formulation alone, or with glycerol, or petrolatum, was applied to the forearms of healthy volunteers (n = 51) with dry skin (Kligman score of 2 or 3). Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry were serially measured for 12 hours following application. An analysis of variance with repeated measures was performed on the evolution of TEWL and corneometry. V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001). The emollient V0034CR presented combined effects, with the petrolatum component improving skin barrier function, with a reduction in TEWL, and the glycerol component improving skin hydration.
Sections du résumé
BACKGROUND
BACKGROUND
The stratum corneum plays an important protective physiological role in providing a barrier to preventing skin desiccation and penetration of external agents. Emollients are used commonly to improve barrier function and skin hydration.
AIMS
OBJECTIVE
The primary objective of this study was to evaluate the effect of an emollient, V0034CR cream, and its active ingredients, to restore the cutaneous barrier. Secondary objectives included assessment of the moisturizing activity of each product and tolerance. The study was not designed to evaluate therapeutic benefit.
METHODS
METHODS
In this randomized, double-blind, 4-arm crossover, clinical pharmacology study, the full emollient V0034CR, its vehicle formulation alone, or with glycerol, or petrolatum, was applied to the forearms of healthy volunteers (n = 51) with dry skin (Kligman score of 2 or 3). Cutaneous permeability by Trans Epidermal Water Loss (TEWL) and skin moisture content by corneometry were serially measured for 12 hours following application. An analysis of variance with repeated measures was performed on the evolution of TEWL and corneometry.
RESULTS
RESULTS
V0034CR emollient significantly reduced mean TEWL compared to vehicle (P = .0018) and vehicle + glycerol (P = .0001) and significantly increased mean corneometry scores compared to vehicle (P < .0001) and vehicle + petrolatum (P < .0001).
CONCLUSIONS
CONCLUSIONS
The emollient V0034CR presented combined effects, with the petrolatum component improving skin barrier function, with a reduction in TEWL, and the glycerol component improving skin hydration.
Substances chimiques
Drug Combinations
0
Emollients
0
V0034CR
0
Paraffin
8002-74-2
Glycerol
PDC6A3C0OX
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1399-1403Subventions
Organisme : Pierre Fabre Dermatologie
Informations de copyright
© 2019 Wiley Periodicals, Inc.
Références
Danby SG. Biological variation in skin barrier function: from A (atopic dermatitis) to X (xerosis). Curr Probl Dermatol. 2016;49:47-60.
Wickett RR, Visscher MO. Structure and function of the epidermal barrier. Am J Infect Contr. 2006;34(10):S98-S110.
Rawlings AV, Harding CR. Moisturization and skin barrier function. Dermatol Ther. 2004;17(s1):43-48.
Yosipovitch G, Xiong GL, Haus E, Sackett-Lundeen L, Ashkenazi I, Maibach HI. Time-dependent variations of the skin barrier function in humans: transepidermal water loss, stratum corneum hydration, skin surface pH, and skin temperature. J Invest Dermatol. 1998;110(1):20-23.
Antonov D, Schliemann S, Elsner P. Methods for the assessment of barrier function. Curr Probl Dermatol. 2016;49:61-70.
Agache P, Mary S, Muret P, Matta AM, Humbert P. Assessment of the water content of the stratum corneum using a sorption-desorption test. Dermatology. 2001;202(4):308-313.
Kligman AM, Lavker RM, Grove GL, Stoudemayer TJ. Some aspects of dry skin and its treatment. In: Kligman AM, Leyden JJ, eds. Safety and efficacy of topical drugs and cosmetics. New York, NY: Grune & Stratton; 1982:221-238.
Berardesca E, Loden M, Serup J, Masson P, Rodrigues LM. The revised EEMCO guidance for the in vivo measurement of water in the skin. Skin Res Technol. 2018;24(3):351-358.
Clarys P, Clijsen R, Taeymans J, Barel AO. Hydration measurements of the stratum corneum: comparison between the capacitance method (digital version of the Corneometer CM 825®) and the impedance method (Skicon-200EX®). Skin Res Technol. 2012;18(3):316-323.
Rota C, Lupi F, Castriota M, Frezzolini A, De Pitá O. Efficacy and tolerability of an emollient cream (Dexeryl®) in patients with contact dermatitis. J Plast Dermatol. 2013;9(1):41-46.
Danby SG, Chalmers J, Brown K, Williams HC, Cork MJ. A functional mechanistic study of the effect of emollients on the structure and function of the skin barrier. Br J Dermatol. 2016;175(5):1011-1019.
Åkerström U, Reitamo S, Langeland T, et al. Comparison of moisturizing creams for the prevention of atopic dermatitis relapse: a randomized double-blind controlled multicentre clinical trial. Acta Derm Venereol. 2015;95(5):587-592.
Blanchet-Bardon C, Tadini G, Machado Matos M, Delarue A. Association of glycerol and paraffin in the treatment of ichthyosis in children: an international, multicentric, randomized, controlled, double-blind study. J Eur Acad Dermatol Venereol. 2012;26(8):1014-1019.
Boralevi F, Saint Aroman M, Delarue A, et al. Long-term emollient therapy improves xerosis in children with atopic dermatitis. J Eur Acad Dermatol Venereol. 2014;28(11):1456-1462.
Martini J, Huertas C, Turlier V, Saint-Martory C, Delarue A. Efficacy of an emollient cream in the treatment of xerosis in diabetic foot: a double-blind, randomized, vehicle-controlled clinical trial. J Eur Acad Dermatol Venereol. 2017;31(4):743-747.
Tiplica GS, Kaszuba A, Malinauskienė L, et al. Prevention of flares in children with atopic dermatitis with regular use of an emollient containing glycerol and paraffin: a randomized controlled study. Pediatr Dermatol. 2017;34(3):282-289.
Tiplica GS, Boralevi F, Konno P, et al. The regular use of an emollient improves symptoms of atopic dermatitis in children: a randomized controlled study. J Eur Acad Dermatol Venereol. 2018;32(7):1180-1187.