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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241161
• Other study ID #: E2913
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2014
• Last updated: September 12, 2014
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Italy	DermIng SRL	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

References & Publications (21)

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. — View 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. — View Citation

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. — View Citation

Calcabrini C, De Bellis R, Mancini U, Cucchiarini L, Potenza L, De Sanctis R, Patrone V, Scesa C, Dachà 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. — View Citation

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. — View 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. — View Citation

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

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. Review. — View Citation

Garcia Ortiz P, Hansen SH, Shah VP, Menné 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. — View 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. — View Citation

Int J Cosm Sci 6: 167-186, 1984 Fernay, Voltaire The World Medical Association (1989)

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. — View 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. — View 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. — View Citation

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. — View Citation

Marttin E, Neelissen-Subnel MT, De Haan FH, Boddé HE. A critical comparison of methods to quantify stratum corneum removed by tape stripping. Skin Pharmacol. 1996;9(1):69-77. — View Citation

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. — View Citation

Takiwaki H. Measurement of skin color: practical application and theoretical considerations. J Med Invest. 1998 Feb;44(3-4):121-6. Review. — View 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

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