Clinical trial NCT02230397: Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream
Official title: Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream: Comparison Within Subjects Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: skin aging
anti-aging cream
wrinkles
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 33
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the "revitalizing" activity of a face cream applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face ritidosis and women aged 55-65 years not habitual user of antiage-creams.

The study foresaw the comparison within subjects of the study product versus placebo (half face method).

It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.


Eligibility criteria: Inclusion Criteria:

* female healthy subjects
* age 45-55 years
* women aged 55-65 years who are not habitual user of antiage-creams
* presence of moderate face ritidosis
* agreeing to present at each study visit without make-up
* accepting to not change their habits regarding food, physical activity, face cleansing and make- up use
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study
* accepting to sign the Informed consent form

Exclusion Criteria:

* pregnancy
* lactation
* change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test
* sensitivity to the test products or theirs ingredients
* subjects whose insufficient adhesion to the study protocol is foreseeable
* participation in a similar study actually or during the previous 3 months
* change in the normal life habits during the month preceding the inclusion
* dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations; recurrent facial/labial herpes)
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy
* drugs/cutaneous medical or surgical procedures at level of the tested area during the previous 3 months
* anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year);
* assumption of drugs able to influence the test results in the investigator opinion

Primary outcomes:
measure: Profilometry: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment)
Secondary outcomes:
measure: Skin electrical capacitance: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment)
measure: Skin plastoelasticity: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment)
measure: Spectophotometry: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment)
measure: Optical colorimetry: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment)
measure: Tape stripping:
timeFrame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment)
measure: Clinical evaluations: change from baseline (T4 and T8 vs. T0)
timeFrame: T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment)
measure: Photographic documentation:
timeFrame: T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DermIng SRL
Study officials:
affiliation: Derming SRL
name: Adele Sparavigna, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ascher B, Coleman S, Alster T, Bauer U, Burgess C, Butterwick K, Donofrio L, Engelhard P, Goldman MP, Katz P, Vleggaar D. Full scope of effect of facial lipoatrophy: a framework of disease understanding. Dermatol Surg. 2006 Aug;32(8):1058-69. doi: 10.1111/j.1524-4725.2006.32230.x.
citation: Bradford MM. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976 May 7;72:248-54. doi: 10.1016/0003-2697(76)90527-3. No abstract available.
citation: De Jongh CM, Verberk MM, Withagen CE, Jacobs JJ, Rustemeyer T, Kezic S. Stratum corneum cytokines and skin irritation response to sodium lauryl sulfate. Contact Dermatitis. 2006 Jun;54(6):325-33. doi: 10.1111/j.0105-1873.2006.00848.x.
citation: De Rigal J, Leveque JL In vivo measurement of the stratum corneum elasticity Bioengineering and the skin 1: 13-23, 1985
citation: Elsner P, Berardesca E, Maibach H Bioengineering of the skin: Water and the stratum corneum CRC Press, Boca Raton, 1994
citation: Elsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998
citation: Fernay, Voltaire The World Medical Association (1989) "World Medical Association Declaration of Helsinki", Hong-Kong.
citation: Fullerton A, Fischer T, Lahti A, Wilhelm KP, Takiwaki H, Serup J. Guidelines for measurement of skin colour and erythema. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1996 Jul;35(1):1-10. doi: 10.1111/j.1600-0536.1996.tb02258.x.
citation: Frankowsky G., Hainich R., GFMesstechnik GmbH Germany DLP-Based 3D metrology by structured light or projected fringe technology for life sciences and industrial metrology Proc. SPIE Photonics West: 1-12, 2009
citation: Garcia Ortiz P, Hansen SH, Shah VP, Menne T, Benfeldt E. Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping. Acta Derm Venereol. 2009;89(1):33-8. doi: 10.2340/00015555-0562.
citation: Glogau RG. Aesthetic and anatomic analysis of the aging skin. Semin Cutan Med Surg. 1996 Sep;15(3):134-8. doi: 10.1016/s1085-5629(96)80003-4.
citation: Grove GL, Grove MJ, Leyden JJ. Optical profilometry: an objective method for quantification of facial wrinkles. J Am Acad Dermatol. 1989 Sep;21(3 Pt 2):631-7. doi: 10.1016/s0190-9622(89)70230-9.
citation: Grove GL, Zerweck CR, Houser TP, Smith GE, Koski NI. A randomized and controlled comparison of gentleness of 2 medical adhesive tapes in healthy human subjects. J Wound Ostomy Continence Nurs. 2013 Jan-Feb;40(1):51-9. doi: 10.1097/WON.0b013e318276f2a4.
citation: Hoppe U, Sauermann G, Lunderstadt R Quantitative analysis of the skin surface by means of digital signal processing J Soc Cosmet Chem 36: 105-123, 1985
citation: Hof, C., Hopermann, H.: University of the Federal Armed Forces, Hamburg Comparison of Replica - and In Vivo - Measurement of the Microtopography of Human Skin
citation: Jaspers S., Bretschneider T., Maerkeer U., Ennen J. Optical topometry with Primos: a powerful tool to prove the efficacy on skin care products in in-vivo studies XXI IFSCC International Congress Proceeding, 430-434
citation: Jaspers S., Hopermann H. et all Rapid in vivo measurement of the topography of human skin by active image triangulation using a digital micromirror device Skin Research and Technology 5: 195-207, 2006
citation: Lademann J, Meinke MC, Schanzer S, Richter H, Darvin ME, Haag SF, Fluhr JW, Weigmann HJ, Sterry W, Patzelt A. In vivo methods for the analysis of the penetration of topically applied substances in and through the skin barrier. Int J Cosmet Sci. 2012 Dec;34(6):551-9. doi: 10.1111/j.1468-2494.2012.00750.x. Epub 2012 Sep 25.
citation: Lademann J, Jacobi U, Surber C, Weigmann HJ, Fluhr JW. The tape stripping procedure--evaluation of some critical parameters. Eur J Pharm Biopharm. 2009 Jun;72(2):317-23. doi: 10.1016/j.ejpb.2008.08.008. Epub 2008 Aug 19.
citation: Leveque JL. EEMCO guidance for the assessment of skin topography. The European Expert Group on Efficacy Measurement of Cosmetics and other Topical Products. J Eur Acad Dermatol Venereol. 1999 Mar;12(2):103-14.
citation: Marttin E, Neelissen-Subnel MT, De Haan FH, Bodde HE. A critical comparison of methods to quantify stratum corneum removed by tape stripping. Skin Pharmacol. 1996;9(1):69-77. doi: 10.1159/000211392.
citation: Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
citation: Rieger M.M., Battista G.W. Some experiences in the safety testing of cosmetics J. Soc. Cosmet. Chem. 15:161 -172 (1964)
citation: Monheit GD, Gendler EC, Poff B, Fleming L, Bachtell N, Garcia E, Burkholder D. Development and validation of a 6-point grading scale in patients undergoing correction of nasolabial folds with a collagen implant. Dermatol Surg. 2010 Nov;36 Suppl 3:1809-16. doi: 10.1111/j.1524-4725.2010.01739.x.
citation: Sachs L Applied statistics: a handbook of techniques Heidelberg: Springer, 536-539, 1981
citation: Salter DC, McArthur HC, Crosse JE, Dickens AD. Skin mechanics measured in vivo using torsion: a new and accurate model more sensitive to age, sex and moisturizing treatment. Int J Cosmet Sci. 1993 Oct;15(5):200-18. doi: 10.1111/j.1467-2494.1993.tb00075.x.
citation: Serri R, Romano MC, Sparavigna A. "Quitting smoking rejuvenates the skin": results of a pilot project on smoking cessation conducted in Milan, Italy. Skinmed. 2010 Jan-Feb;8(1):23-9.
citation: Sparavigna A., Setaro M., Galbiati G. Osservazioni sull'elasticità della pelle Cosmesi Dermatologica 22:68-78, 1988
citation: Sparavigna A., Setaro M., A new evaluation method of skin plastoelasticity in skin Pharmacology and toxicology. Recent advances Plenum Publishing Corporation, New York, London: 295-298, 1990
citation: Sparavigna A., Galbiati G. La plastoelasticità cutanea: Metodi di indagine e significato clinico Cronica Dermatologica 4: 509-517, 1992
citation: Sparavigna A., Setaro M. Misurazione delle proprietà meccaniche della cute mediante metodi di torsione In:"Diagnostica non invasiva in dermatologia" A cura di Stefania Seidenari, EDRA Medical Publishing & New Media, Milano, 1998, 323-328
citation: Sparavigna A., Setaro M. Elasticità della pelle La Pelle: Dermatologia, anno 14, mag-giu (5) 2009
citation: Sparavigna A, Di Pietro A, Setaro M. 'Healthy skin': significance and results of an Italian study on healthy population with particular regard to 'sensitive' skin. Int J Cosmet Sci. 2005 Dec;27(6):327-31. doi: 10.1111/j.1467-2494.2005.00287.x.
citation: Setaro M., Sparavigna A. Is it possible to define a biological age of the skin? Preprints of 1st Joint Meeting: 14th International Congress for Bioengineering and the Skin and 8th Congress of the International Society for Skin Imaging. May 21-24, 2003, Hamburg, Germany
citation: Serup J, Agner T. Colorimetric quantification of erythema--a comparison of two colorimeters (Lange Micro Color and Minolta Chroma Meter CR-200) with a clinical scoring scheme and laser-Doppler flowmetry. Clin Exp Dermatol. 1990 Jul;15(4):267-72. doi: 10.1111/j.1365-2230.1990.tb02087.x.
citation: Taelman M-C, Dederen J. C. Relative performance testing of formulations: emulsifiers Cosmetics &Toiletries magazine August 2000; 115: 37-42
citation: Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.
citation: Tagami H, Ohi M, Iwatsuki K, Kanamaru Y, Yamada M, Ichijo B. Evaluation of the skin surface hydration in vivo by electrical measurement. J Invest Dermatol. 1980 Dec;75(6):500-7. doi: 10.1111/1523-1747.ep12524316. No abstract available.
citation: Weigmann H, Lademann J, Meffert H, Schaefer H, Sterry W. Determination of the horny layer profile by tape stripping in combination with optical spectroscopy in the visible range as a prerequisite to quantify percutaneous absorption. Skin Pharmacol Appl Skin Physiol. 1999 Jan-Apr;12(1-2):34-45. doi: 10.1159/000029844.
citation: Wilhelm KP, Elsner P, Berardesca E, Maibach HI Bioengineering of the skin: Skin surface imaging and analysis CRC Press, Boca Raton, 1997