Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: plantaricin a - rejuvenating cream; Other: plantaricin a - rejuvenating serum; Other: plantaricin a - antioxidant serum

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Monza, Italy, 20900
    • DermIng SRL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult volunteers of both sexes, aged more than 18 years old
• Volunteers in a good general state of health in the Investigator opinion
• Volunteers not taking drugs or undergoing surgical procedure
• Volunteers who are giving a written informed consent.

Exclusion Criteria:

• Pregnancy (only for female subjects)
• lactation (only for female subjects)
• change in the normal habits in the last month
• participation in a similar study during the previous month
• known allergy to one or several ingredients of the products on trial
• insufficient adhesion to the study protocol
• dermatological disease
• clinical and significant skin condition on the test area (e.g. lesions, scars, malformations)
• diabetes
• endocrine disease
• hepatic, renal or cardiac disorder
• cancer
• topical drugs or surgical procedure on the test areas during the previous 3 months
• systemic corticosteroids
• aspirin or non-steroid anti-inflammatory drugs (FANS)
• diuretic drugs
• antibiotics and chemotherapics
• pshycotropic drugs
• retinoids
• psoralens
• cardiologic and vascular drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: plantaricin a - rejuvenating cream; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes	Other: plantaricin a - rejuvenating cream; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
Active Comparator: plantaricin a - rejuvenating serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes	Other: plantaricin a - rejuvenating serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
Active Comparator: plantaricin a - antioxidant serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes	Other: plantaricin a - antioxidant serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
Active Comparator: plantaricin a (rejuvenating cream +rejuvenating serum); single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes	Other: plantaricin a - rejuvenating cream; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes; Other: plantaricin a - rejuvenating serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
Active Comparator: plantaricin a (rejuvenating cream + antioxidant serum); single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes	Other: plantaricin a - rejuvenating cream; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes; Other: plantaricin a - antioxidant serum; single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0)	Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)	After 1 (T1h) hour from products application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)	Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)	After 6 (T6h) hours from products application
Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)	Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth)	After 24 (T24h) hours from products application
Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)	The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan	After 1 (T1h) hour from products application
Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)	The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan	After 6 (T6h) hours from products application
Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)	The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan	After 24 (T24h) hours from products application
Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0)	Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.	After 1 (Th1) hour from products application
Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0)	Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.	After 6 (T6h) hours from products application
Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0)	Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope.	After 24 hours (T24h) from products application

Collaborators and Investigators

• Sponsor: Derming SRL

Publications and helpful links

General Publications

• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.
• Benzie IF, Strain JJ. The ferric reducing ability of plasma (FRAP) as a measure of "antioxidant power": the FRAP assay. Anal Biochem. 1996 Jul 15;239(1):70-6. doi: 10.1006/abio.1996.0292.
• 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.
• Buonocore D, Lazzeretti A, Tocabens P, Nobile V, Cestone E, Santin G, Bottone MG, Marzatico F. Resveratrol-procyanidin blend: nutraceutical and antiaging efficacy evaluated in a placebocontrolled, double-blind study. Clin Cosmet Investig Dermatol. 2012;5:159-65. doi: 10.2147/CCID.S36102. Epub 2012 Oct 5.
• 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: 10.1006/abio.1976.9999. No abstract available.
• Calcabrini C, De Bellis R, Mancini U, Cucchiarini L, Potenza L, De Sanctis R, Patrone V, Scesa C, Dacha M. Rhodiola rosea ability to enrich cellular antioxidant defences of cultured human keratinocytes. Arch Dermatol Res. 2010 Apr;302(3):191-200. doi: 10.1007/s00403-009-0985-z. Epub 2009 Aug 25.
• Corcuff P, Chatenay F, Leveque JL. A fully automated system to study skin surface patterns. Int J Cosmet Sci. 1984 Aug;6(4):167-76. doi: 10.1111/j.1467-2494.1984.tb00373.x.
• 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.
• Int J Cosm Sci 6: 167-186, 1984 Fernay, Voltaire The World Medical Association (1989)
• Elsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998
• Fuga GC, Spina C, Cavallotti C, Di Palma A, Lombardi G, Marmo W Computerized reflected optical densitometry. A research on the colour of the skin. Journal of Applied Cosmetology, 8:91-110,1990
• 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.
• 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.
• 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.
• 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.
• Lindemann U, Wilken K, Weigmann HJ, Schaefer H, Sterry W, Lademann J. Quantification of the horny layer using tape stripping and microscopic techniques. J Biomed Opt. 2003 Oct;8(4):601-7. doi: 10.1117/1.1609200.
• 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.
• Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer, 1981:536-539
• 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.
• Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6.
• 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.

Helpful Links

• Investigation Center
• Sponsor

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: skin eythema; rejuvenating cream; rejuvenating serum; antioxidant serum
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Protective Agents; Anti-Bacterial Agents; Antioxidants; Bacteriocins
• Other Study ID Numbers: E2913