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Clinical safety

Always on the safe side

Index:

Patch Test: Single Closed Application (S) PT

Title

Human Patch Test under dermatological control

Objective

To confirm the skin compatibility of a product after a 24/48 hour single application under patch

Schedule

Duration of the study: 3/4/5 days

Beginning: From 1 to 2 weeks upon receipt of the samples

Report: 2 weeks after the end of the study

Methodology

Clinical assessment of the cutaneous response

Procedure

Skin examination of application site

Application of the product diluted/as supplied to the back/upper arm of subjects under occlusive or semi occlusive patch (depending on its composition and/or category or class of product)

Patch removal after 24/48 hour-contact with the skin

Skin examination of the application site at least 15 minutes-1h/24h/48h later

Optional: Additional readings

Production laboratory

  • Eurofins ATS, Aix-en-Provence, FRANCE
  • Eurofins EVIC France, Bordeaux, FRANCE
  • Eurofins EVIC Spain, Barcelona, SPAIN
  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA


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Patch Test: Repeated Closed Application (R) PT

Title

Human Patch Test - 21 days cumulative irritability test under dermatological control

Objective

To confirm the absence of cumulative irritant potential of a product after repeated applications under patch

Schedule

Duration of the study: 22 days

Beginning: According to annual schedule (several panels once a month)

Report: 2/3 weeks after the end of the study

Methodology

Clinical assessment of the cutaneous response

Procedure

Skin examination of application site

Application of the product to the back of the subjects 3 times per week for 3 consecutive weeks under occlusive or semi-occlusive patch (according to its composition and/or category or class of product)

Patch removal after 48/72 hour-contact with the skin

Skin examination of the application site at least 15 minutes after each patch removal

Production laboratory

  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins BioPharma Product Testing, Rome, ITALY


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Frosch-Kligman Soap Chamber Test

Title

Frosch-Kligman Soap Chamber Test under dermatological control

Objective

To confirm and to compare the skin compatibility of products, after repeated applications under patch

Schedule

Duration of the study: 8 days

Beginning: From 1 to 2 weeks upon receipt of the samples

Report: 2 weeks after the end of the study

Methodology

Clinical assessment of the cutaneous response

Procedure

Skin examination of application site

Application of the diluted products to the forearm of subjects under occlusive patch 5 times per week

Patch removal after 24/36 hour-contact with the skin

Skin examination of application site at least 15 minutes/24h/72h after each patch removal

Production laboratory

  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA


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Sensitisation Test

Title

Human Repeated Insult Patch Test (HRIPT) - Final Safety Clinical Test (FSCT)

Objective

To confirm the absence of delayed contact sensitisation potential and assess the skin compatibility of a product after repeated applications under maximising conditions

Schedule

Duration of the study: 6/8 weeks

Beginning: According to annual schedule (several panels once a month)

Report: 2/3 weeks after the end of the study

Methodology

Clinical assessment of the cutaneous response, according to adapted method of Marzulli & Maibach or Shelanski

Procedure

Induction phase:

Skin examination of application site

Application of the product to the back of the subjects 3 times per week for 3 consecutive weeks under occlusive or semi occlusive patch (according to its composition and/or category or class of product)

Patch removal after 24/48/ or 72 hour-contact with the skin

Skin examination of the application site after each patch removal

Rest period: 2 consecutive weeks at least (4 weeks at the most) with no product application

Challenge phase: Single application of the product under patch to the induction site and to a virgin site. Patch removal after 24 / 48 hour-contact with the skin. Skin examination of the application sites before application and at least 15 minutes/24 hours/48 hours/72 hours/96 hours after patch removal

Production laboratory

  • Eurofins EVIC Romania, Bucharest, ROMANIA


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Phototoxicity Test

Title

Human Photo-Patch test under dermatological control

Objective

To confirm the absence of phototoxic potential of a product, after single application under patch and UVA exposure

Schedule

Duration of the study: 4 days

Beginning: From 1 to 2 weeks upon receipt of the samples

Report: 2 weeks after the end of the study

Methodology

Clinical assessment of cutaneous response

Procedure

Skin examination of application sites

Application of the product (in duplicate sites) to the back of subjects under occlusive or semi occlusive patch (depending on its composition and/or category or class of product)

Patch removal after 24 hour contact with the skin

Skin examination of the application sites 30 minutes after

Exposure to UVA radiation (10 J/cm2) on one test site (second site= test non-irradiated site) and on an untreated control site

Skin examination of test and control sites 24 and 48 hours (or more if needed) after the irradiation

Production laboratory

  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins EVIC Spain, Barcelona, SPAIN


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Photosensitisation Test

Title

Human Photo-Patch test under dermatological control

Objective

To confirm the absence of photosensitisation potential of a product, after repeated applications under patch and UV exposure

Schedule

Duration of the study: 6/8 weeks

Beginning: According to annual schedule (several panels once a month)

Report: 2/3 weeks after the end of the study

Methodology

Clinical assessment of the cutaneous response, according to adapted method of Kaidbey and Kligman (Identification of Topical Photosensitising Agents in Humans)

Procedure

Induction phase:

Skin examination of application site

Application of the product to the back of the subjects 2 times per week for 3 consecutive weeks under occlusive or semi occlusive patch (according to its composition and/or category or class of product)

Patch removal after 24 hour- contact with the skin

Exposition to UV radiation about 30 minutes after each patches removal

Skin examination of the application site after each patch removal (before and after the exposition)

Rest period:

2 consecutive weeks at least (4 weeks at the most) with no product application

Challenge phase:

Single application of the product under patch to the induction site and to a virgin site

Patch removal after 24 hour-contact

Exposition to UV radiation about 30 minutes after patch removal

Skin examination of the application sites before application and 30 minutes after patch removal (before and after exposition), then 24 and 48 hours after patch removal

Production laboratory

  • External partner of Eurofins Group POLAND, via ATS
  • Eurofins EVIC Romania, Bucharest, ROMANIA


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Open Test: Single or Repeated Open Application

Title

Human Open test under dermatological and/or ophthalmological and/or stomatological and/or gynaecological control

Objective

To confirm the compatibility of a product after one or several applications under controlled conditions very close to its normal conditions of use

Schedule

Duration of the study: According to the type of product and its conditions of use

Beginning: From 1 to 2 weeks upon receipt of the samples

Report: 2/3 weeks after the end of the study

Methodology

Clinical assessment of cutaneous response

Procedure

Clinical examination of application site

Controlled application of the product by the responsible technician at the investigating centre

Clinical examination within the hour following the application

Optional:

Additional applications at home

Professional pictures

Several specialist controls

Production laboratory

  • Eurofins ATS, Aix-en-Provence, FRANCE
  • Eurofins EVIC France, Bordeaux, FRANCE
  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins EVIC Spain, Barcelona, SPAIN


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Open Test on the Elbow Fold

Title

Human Open test on the elbow fold under dermatological control

Objective

To confirm the skin compatibility of a product after repeated application under controlled and slightly exaggerated conditions

Schedule

Duration of the study: 5 days

Beginning: From 1 to 2 weeks upon receipt of the samples

Report: 3-4 weeks after the end of the study

Methodology

Clinical assessment of cutaneous response

Procedure

Skin examination of application site

Repeated application for 5 consecutive days of the product by a technician at the investigating centre to one of the elbow folds

Flexion of both forearms (test and control) for 15 minutes after each application

Stretching of the forearms for 30 minutes

Skin examination (checking of the skin compatibility)

Optional:

Additional application at home (without flexion)

Test on the knees fold or armpits

Production laboratory

  • Eurofins ATS, Aix-en-Provence, FRANCE
  • Eurofins EVIC France, Bordeaux, FRANCE
  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins EVIC Spain, Barcelona, SPAIN


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In Use Test Under Clinical Control

Title

Human In Use test under dermatological and/or paediatrician and/or ophthalmological and/or gynaecological and/or stomatological/dental control and/or geriatric control and/or physiotherapist control and/or ENT podiatrist control

Objective

To confirm the acceptability of the product after repeated application under normal conditions of use

Optional: To assess subjectively its cosmetic qualities and efficacy

Schedule

Duration of the study: Depending on the product (at least 14 days and intermediate control option)

Beginning: 2 weeks upon receipt of the samples

Report: 3-4 weeks after the end of the study

Methodology

Clinical assessment of cutaneous/ocular/hair… response

Procedure

Clinical examination of application site

Use of the product at home by the subjects for 14 days or more following the instructions for use

Clinical examination (checking of the acceptability)

Optional:

Cosmetic qualities and efficacy questionnaire

Professional more specialists pictures

Production laboratory

  • Eurofins ATS, Aix-en-Provence, FRANCE
  • Eurofins EVIC France, Bordeaux, FRANCE
  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins EVIC Spain, Barcelona, SPAIN

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Non-Comedogenenicity / Non-Acnegenecity

Title

Non-comedogenicity / Non-acnegenicity test under dermatological control

Objective

To check the non-comedogenicity / non-acnegenicity and confirm the skin acceptability of a product after repeated applications under normal conditions of use

Optional: To assess subjectively its cosmetic qualities and efficacy

Schedule

Duration of the study: at least 28 days

Beginning: 2 weeks upon receipt of the samples

Report: 3-4 weeks after the end of the study

Methodology

Counting of the retentional and /or inflammatory elements and clinical assessment of the cutaneous response

Procedure

Skin examination of application site

Count of the retentional and inflammatory elements

Use of the product at home by the subjects for 28 days following the instructions for use

 

Optional:

Cosmetic qualities and efficacy questionnaire

Professional pictures

Statistical analysis of the data

Production laboratory

  • Eurofins EVIC France, Bordeaux, FRANCE
  • Eurofins BioPharma Product Testing, Rome, ITALY
  • Eurofins EVIC Romania, Bucharest, ROMANIA
  • Eurofins EVIC Spain, Barcelona, SPAIN


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