Qualification of a precise and easy-to-handle sweat casting imprint method for the prediction and quantification of anti-perspirant efficacy
| Autor: | Andreas Herpens, Robert Dr. Schmucker, Volker Schreiner, Reza Keyhani, Horst Wenck, Joachim Ennen, Stefan Scheede, I. Thielecke |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Aging Adolescent Pharmaceutical Science Dermatology SWEAT Food and drug administration Young Adult Colloid and Surface Chemistry Untreated control Sweat gland Drug Discovery Antiperspirants medicine Humans Sweat Aged Test site Chemistry Reproducibility of Results Test method Middle Aged medicine.anatomical_structure Chemistry (miscellaneous) Casting (metalworking) Female Quantitative analysis (chemistry) Biomedical engineering |
| Zdroj: | International journal of cosmetic science. 31(3) |
| ISSN: | 1468-2494 |
| Popis: | A time- and cost-effective sweat casting method using the forearm as test site to assess the efficacy of several anti-perspirant formulations with a low number of test subjects has been evaluated and qualified. The imprint sweat casting method is based on a 2-component silcone-imprint technique to measure the efficacy of more than eight products in parallel with the same test subject. In studies using aluminum chlorohydrate (ACH) formulations as test anti-perspirants, a clear-cut correlation could be demonstrated between sweat gland activities measured by the imprint method and gravimetric measurement of sweat gland activities. Concentration-dependent inhibition of sweat gland activity could be observed with the imprint technique up to an ACH concentration of 15%, and all formulations containing 2% ACH or above resulted in statistically significant reduction of sweat gland activity (P < 0.001) when compared with untreated control areas. Furthermore, the SDs of individual studies using the imprint technique were in a range of +/-20% of sweat gland activity, which can be regarded rather low for in vivo measurements of a complex process like sweat secretion. A group-wise comparison between the measurements of anti-perspirant activity as determined by the imprint protocol and the Food and Drug Administration (FDA) Guideline compliant gravimetric hot-room protocol revealed that the test results for anti-perspirant activity obtained with the imprint protocol are similar to those obtained with the hot-room protocol. Moreover, the data generated with the imprint protocol have a high predictive value for the outcome of a later guideline-compliant hot-room test. As the imprint casting method tends to be a little more sensitive for formulations with low anti-perspirant activity, and seems to be associated with less interassay variability than the standard gravimetric hot-room test, the imprint casting method may select products which later fail to pass the standard gravimetric hot-room test. Meanwhile the imprint sweat casting has proven to be a robust method useful to support efficacy-oriented product development. Therefore, in later stages of utilization it might even evolve into an efficient claim substantiation tool. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|