SERVICESFrequently Asked Questions

Find below responses to the most common questions regarding efficacy and safety testing for cosmetics and ingredients

FAQRelated to testing

Which are the steps to contract our services?

First, contact us using our email address or the website contact form. Describe us your project and we will discuss different proposals according to your needs. Once we agreed on the conditions, we will send you an official quotation describing the services, which has to be signed and sent back to us.

Once we received the signed quotation, the project starts. We will ask you to fill the Product Form with information about the samples to be tested and you can proceed with the shipment. Once we receive the samples in our facilities, we will proceed with the experimentation. In the meantime between signing the quotation and receiving the sample, we will prepare reagents (in vitro) or the panel recruitment (clinical) to start working as soon as possible after receiving your samples.

How much sample is needed for the study?

In vitro efficacy testing: Depending on the specific protocol to be performed, small samples (200-400 µg in powder or µL in liquid) may be usually required. For longer protocols, larger samples (0.5-1 gram or 4-6 mL) may be required.

Clinical efficacy testing: The number of samples required for the clinical tests depend on the number of volunteers included in the study. We usually ask for “Number of Volunteers + 5 extra (to solve possible problems)” samples. The necessary quantity of sample depends on the specific application of the product, but we usually recommend 25-30 mL for 1-month face care treatment and 50-60 mL for 2-months treatment.

In vitro safety testing: According to the specific protocol, 2 different samples of 0.5-1 gram (powder) or 5-10 mL (liquid), will be required.

What data is included in the clinical tests?

Unless agreed different conditions, all of our clinical studies include in the quoted price the self-assessment questionnaire (maximum 20 questions to be designed with the client), macroscopic pictures from a digital camera, marketing images according to the specific assay (wrinkles, dark spots, neck jowls, etc.), and dermatological surveillance, for all of the volunteers.

Upon request to the client, a marketing presentation with the images of the different volunteers in power point or access format, may be also prepared and delivered, together with the final results.

Which are our payment conditions?

Prices do not include VAT neither other taxes, and are based on the current rates at the time of sending the offer to the client. Applicable taxes are the ones in force at the billing date.

Dermaclaim’s payment conditions are fifty percent (50 %) of the total amount budgeted when signing the quotation, and the remaining fifty percent (50 %) upon delivery of the final results report, except previously agreed conditions; using bank transfer in favor of Dermaclaim Lab S.L., with a maximum period of 30 days invoice date.

Which are the accreditations of the laboratory?

Dermaclaim is certified in Quality Management System (ISO 9001:2015) since August 2022 and Crédit d’Impot Recherche (French Research Tax Credit) since December 2023. Moreover, Information Security Management System (ISO 27001:2022) is being implementing from November 2023 and expected to be certified on June 2024. For the end of 2024, Spanish Innovative SME Enterprises seal will be also obtained.

It is also important to remark that clinical protocols are in accordance with the Scientific Committee on Consumer Safety (SCCS) guidance, meeting all international standards for research studies involving human subjects, Structure and Content of Clinical Study Reports from ICH Harmonised Tripartite Guideline; International Recommendations ICH Topic E6, European Parliament and Council Guideline 2001/20/CE, the Good Clinical Practices (ICH-GCP), and the World Medical Association. They are conducted pursuant to the Declaration of Helsinki (1964), with the amendments of Tokyo (1975), Venice (1983), Hong Kong (1989), South Africa (1996), Edinburgh (2000), Seoul (2008), and Fortaleza (2013).

Moreover, in vitro bioassays and clinical studies follow the “Guidelines for the Evaluation of the Efficacy of cosmetic Products”, COLIPA (May, 2008).

FAQRelated to results

Are the results recognized worldwide?

Since its start on October 2021, Dermaclaim has performed more than 400 projects for more than 90 clients worldwide (USA, Australia, India, Brazil, South Africa, Colombia, Germany, United Kingdom, Italy, Switzerland, Israel, France, Spain, Norway, Lebanon, New Zealand…), both for active ingredients suppliers and end-product manufacturers.

In vitro and clinical results are recognized all around the world for all the different regulations, including Europe (Regulation EC N° 1223/2009), United States (Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act), China (Cosmetics Supervision and Administration Regulations, CSAR), Australia (Australian Competition and Consumer Commission, ACCC), etc.

How long does it take to receive test results?

Preliminary results are immediately sent to the customer, after finishing the study and processing all the data. The final report is usually sent 3-5 days after the preliminary results. Find below more information about the specific timings for each type of testing:

In vitro efficacy testing: The final report is usually delivered in 4-5 weeks after sample reception. However, there are simple protocols that could be conducted in 1-2 days and the report delivered in the same week of receiving the sample. More complex protocols may take longer, according to each specific project.

Clinical testing: The normal timings for an accurate panel recruitment are 4 weeks, including 2-weeks previous washout phase. After tha, 4-8 weeks for the treatment and 8-10 days to process all the data and deliver the complete final report.

In vitro safety testing: The final report is usually delivered in 3-4 weeks after sample reception for most of the protocols, excluding Ames Test OECD 471 and Franz Cell Absorption 428 (5-6 weeks).

Who is the owner of the results?

The ownership of the results obtained after contracting our services and the industrial and intellectual property rights that may be arised from them, belong exclusively to the customer, unless Dermaclaim and the Client agree other different conditions.

Dermaclaim can participate in a scientific publication derived from the studies performed, but this decision will depend only on the customer. Dermaclaim has no rights on the obtained results.

Are the results of the studies confidential?

The complete final report, the raw data and the testing protocols are completely Confidential and will not be shared with third parties. All the information provided from the Client to Dermaclaim and from Dermaclaim to the Client, including information about materials, reagents and protocols adopted by Dermaclaim, will be also considered as confidential and will not be shared with external parties.

According to customer’s needs, it is very common to start conversations by signing a Non-disclosure Agreement (NDA), in order to protect the confidentiality of all the information and results.

How long the extra samples will be stored?

Dermaclaim will store the extra samples that were not necessary for the development of the contracted services during a period of twelve (12) months, unless otherwise established with the customer or due to regulatory international guidelines.

Once this period is over, the samples will be unusuable and disposed, according to the corresponding regulations. Dermaclaim is not responsible for the possible variations of the samples during the period of storage.
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