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

NCT02241161 | Completed Phase 3 DMC

• 1 other identifier: E2913
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Keywords

skin eythema; rejuvenating cream; rejuvenating serum; antioxidant serum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0)

  After 6 (T6h) hours from products application

• Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0)

  After 24 (T24h) hours from products application

• Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0)

  After 1 (T1h) hour from products application

• Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0)

  After 6 (T6h) hours from products application

• Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0)

  After 24 (T24h) hours from products application

Study Arms (5)

plantaricin a - rejuvenating cream

ACTIVE COMPARATOR

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

plantaricin a - rejuvenating serum

ACTIVE COMPARATOR

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

plantaricin a - antioxidant serum

ACTIVE COMPARATOR

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

plantaricin a (rejuvenating cream +rejuvenating serum)

ACTIVE COMPARATOR

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; Other: plantaricin a - rejuvenating serum

plantaricin a (rejuvenating cream + antioxidant serum)

ACTIVE COMPARATOR

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; Other: plantaricin a - antioxidant serum

Interventions

plantaricin a - rejuvenating cream OTHER

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 cream + antioxidant serum); plantaricin a (rejuvenating cream +rejuvenating serum); plantaricin a - rejuvenating cream

plantaricin a - antioxidant serum OTHER

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 cream + antioxidant serum); plantaricin a - antioxidant serum

plantaricin a - rejuvenating serum OTHER

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 cream +rejuvenating serum); plantaricin a - rejuvenating serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng SRL

Monza, Monza, 20900, Italy

Location

Related Publications (21)

• 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.

  PMID: 23071399 BACKGROUND

• 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.

  PMID: 8660627 BACKGROUND

• 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.

  PMID: 942051 BACKGROUND

• 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.

  PMID: 19705137 BACKGROUND

• 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.

  PMID: 19467109 BACKGROUND

• 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.

  PMID: 16787454 BACKGROUND

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

  BACKGROUND

• Elsner P, Barel AO, Berardesca E, Gapard B, Serup J Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology Karger, 1998

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8896947 BACKGROUND

• 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.

  PMID: 19197539 BACKGROUND

• 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.

  PMID: 23202590 BACKGROUND

• ICH Harmonised Tripartite Guideline - Guideline for Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: May 1996

  BACKGROUND

• 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.

  PMID: 22957937 BACKGROUND

• 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.

  PMID: 18775778 BACKGROUND

• 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.

  PMID: 14563197 BACKGROUND

• 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.

  PMID: 8868035 BACKGROUND

• Sachs L Applied statistics: a handbook of techniques. Heidelberg: Springer, 1981:536-539

  BACKGROUND

• 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.

  PMID: 2208776 BACKGROUND

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

  PMID: 9597799 BACKGROUND

• 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.

  PMID: 10325582 BACKGROUND

Related Links

• Investigation Center
• Sponsor

Study Officials

• Adele Sparavigna, Doctor

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: September 16, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 16, 2014

Record last verified: 2014-03

Locations

IT (1)