Skin Compatibility of P&G Laundry Detergents
We often share the details and results of our skin compatibility program with panels of dermatologists. These dermatologists agree that:
- Our laundry detergent products do not pose concerns about irritation or skin allergies for our consumers.
- roperly formulated laundry detergents with enzymes (i.e., biological detergents) do not pose irritation or sensitization concerns.
- Although laundry detergents are often assumed to be responsible for skin reactions, they are rarely the true cause.
- Panels are usually composed of dermatologists from different research or teaching hospitals. They reviewe all available information on the potential skin effects of each of the ingredients that make up our detergent formulations, as well as the products themselves.
The skin effects of P&G detergents
Studies on irritation: With the help of volunteer panelists, a variety of studies have been conducted under conditions that exaggerate the exposures that consumers would expect to have through normal use of our laundry detergents. The results demonstrate that P&G laundry detergents and fabrics laundered in P&G detergents are not irritating to the skin. 
See the details
Studies on skin sensitization (allergies): A number of studies have been conducted on the different versions of detergents involving over 1200 volunteer panelists. There has been no evidence that our laundry detergents cause skin allergies, even under highly exaggerated exposures.See the details
Studies to detect any adverse skin effects under real use conditions: With the help of volunteer panelists, we've conducted long term home use testing to evaluate the potential of the product to cause either skin irritation or skin allergy with realistic product exposures. Volunteer panelists use our product for extended periods of time in place of their usual detergent. A professional assessment of the skin condition confirmed that our products did not cause skin irritation or skin allergy.See the details
Special studies on biological products (products with enzymes): We've conducted a number of tests for skin irritation, skin sensitization (allergy) and skin effects under real use conditions on our biological products (i.e., those products with enzymes). Our biological products have the same excellent skin compatibility profile as our non-biological products. The biological products are mild to the skin, and there is no evidence that they produce skin allergies under real use and exaggerated use conditions.See the details
Underpinning the GCP regulation is the requirement for all human research to be approved by an Institutional Review Board/Ethics Committee (IRB/EC). The sole charge of the IRB/EC is to protect the rights of human research subjects, assuring that 1) the study protocol is well designed to provide meaningful data, 2) the risk to the health of the subject is justified relative to the benefit of the knowledge to be gained by the research, 3) that research subjects are not coerced into participating, i.e. participation is pure voluntary, and 4) that each potential subject is fully informed in writing of the a) intent of the research, b) the potential risks of the research, c) full knowledge of their rights, and d) telephone numbers to call for help in the event of an adverse event or if they have any questions regarding the study or their subject rights.
The following are links to the FDA and ICH GCP documents.
http://www.access.gpo.gov/.../21cfr50_01.html
http://www.access.gpo.gov/.../21cfr56_01.html
http://www.fda.gov/.../959fnl.pdf
See the details Studies on skin sensitization (allergies): A number of studies have been conducted on the different versions of detergents involving over 1200 volunteer panelists. There has been no evidence that our laundry detergents cause skin allergies, even under highly exaggerated exposures.
See the details Studies to detect any adverse skin effects under real use conditions: With the help of volunteer panelists, we've conducted long term home use testing to evaluate the potential of the product to cause either skin irritation or skin allergy with realistic product exposures. Volunteer panelists use our product for extended periods of time in place of their usual detergent. A professional assessment of the skin condition confirmed that our products did not cause skin irritation or skin allergy.
See the details Special studies on biological products (products with enzymes): We've conducted a number of tests for skin irritation, skin sensitization (allergy) and skin effects under real use conditions on our biological products (i.e., those products with enzymes). Our biological products have the same excellent skin compatibility profile as our non-biological products. The biological products are mild to the skin, and there is no evidence that they produce skin allergies under real use and exaggerated use conditions.
See the details
Overview of good clinical practice regulations (GCPs)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, performing, monitoring, auditing, recording, analysis and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. GCP is codified by FDA in 21CFR50,56.Underpinning the GCP regulation is the requirement for all human research to be approved by an Institutional Review Board/Ethics Committee (IRB/EC). The sole charge of the IRB/EC is to protect the rights of human research subjects, assuring that 1) the study protocol is well designed to provide meaningful data, 2) the risk to the health of the subject is justified relative to the benefit of the knowledge to be gained by the research, 3) that research subjects are not coerced into participating, i.e. participation is pure voluntary, and 4) that each potential subject is fully informed in writing of the a) intent of the research, b) the potential risks of the research, c) full knowledge of their rights, and d) telephone numbers to call for help in the event of an adverse event or if they have any questions regarding the study or their subject rights.
The following are links to the FDA and ICH GCP documents.
http://www.access.gpo.gov/.../21cfr50_01.html http://www.access.gpo.gov/.../21cfr56_01.html http://www.fda.gov/.../959fnl.pdf