Why Zinc Pyrithione?
Zinc Pyrithione when used at the appropriate percentage, with the appropriate Drug Facts label, and when made at a factory that follows current Good Manufacturing Practices is an FDA approved active ingredient proven to be highly effective in helping reduce scalp flakes associated with seborrheic dermatitis and dandruff.
This ingredient has been shown in many double-blind studies to be effective in controlling the clinically evident scaling in dandruff. Three different zinc pyrithione shampoos were evaluated in 13 clinical trials conducted by 5 investigators at different test sites. All tests were double blinded. One group used a control shampoo and the other the zinc pyrithione shampoo. The study participants shampooed once or twice a week for 6-10 weeks. Results showed that all three medicated shampoos were effective in reducing dandruff. Use of shampoo base alone (the control) showed some improvement in scalp scaling in the above studies. Thus frequent shampooing has been suggested as a treatment for dandruff .
A Study from the International Journal of Cosmetic Science in 2014 Using new spectroscopic technology was able to look at top most layer of skin, the stratum corneum, to compare dandruff scalp to non-dandruff scalp and see the effects of a shampoo with pyrithione zinc (PZ). It showed that dandruff scalp has lower natural moisturizing factors, elevated levels of urea, lower levels of lactic acid, and deeper sebum than non-dandruff scalp. The PZ shampoo restored those levels to the characteristics of-non dandruff scalp .
Seborrheic Dermatitis and Zinc Pyrithione Shampoos
Cradle cap or infant dandruff is the flaky, scaly condition that develops on babies’ scalps and eyebrows in the first few months of life. When it also involves redness behind ears, armpits, neck folds and groin area it tends to be referred to as seborrheic dermatitis or seborrhea. Many pediatricians encounter this at least 2- 4 times per day in their office. 40% of children in their first year of life have these issues.
Prior to the creation of Happy Cappy Medicated Shampoo for Seborrheic Dermatitis and Dandruff with active ingredient Pyrithione Zinc, 70% of pediatricians would suggest adult dandruff shampoos to fix this problem. Zinc pyrithione shampoo or selenium sulfide shampoo were the two most common active ingredients suggested by pediatric clinicians.
Happy Cappy is the first OTC (over the counter) product with an active ingredient for dandruff and seborrheic dermatitis made for a child. No longer do pediatricians have to recommend an ADULT product for a PEDIATRIC problem. We made Happy Cappy Medicated Zinc Pyrithione Shampoo so that families and pediatricians no longer had to use products with harsh surfactants containing common skin irritants like dyes, fragrances, sulfates, and parabens.
EFFECTIVENESS & MAKING HAPPY CAPPY 0.95% Pyrithione Zinc
In 1986, companies that made 1% Pyrithione Zinc (PZ) wanted to be able to sell in foreign markets like Germany where 0.95% was the max concentration. Data was reviewed by the FDA that showed similar improvements in scaling and determined that 0.95% vs. 1% was not apt to cause any decrease in product effectiveness . In the Final Monograph, produced in 1991, the strength of PZ can be between 0.3-2% for dandruff and 0.95% and 2% for seborrheic dermatitis. Having a lower percentage of PZ can cause less dryness.
Is Zinc Pyrithione Safe
Pyrithione Zinc (PZ) is insoluble in water and not easily absorbed through skin when topically applied or easily absorbed through mucous membranes if swallowed. Data from evaluated studies by FDA showed topically applied PZ has a high safety margin, no contact sensitization, and no photosensitization. From 1964 to 1982, only 3 cases of allergic contact dermatitis had been reported .
Zinc Pyrithione Shampoo is GRASE–GENERALLY REGARDED AS SAFE AND EFFECTIVE (GRASE)
GRASE is an FDA designation. In order to conclude a GRASE determination, a drug must satisfy three criteria. First, the particular drug must have been subjected to adequate and well controlled clinical investigations that establish the product as safe and effective. Second, those investigations must have been published in the scientific literature available to qualified experts. Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. At a minimum, the general acceptance of a product as GRASE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a new drug application.
Happy Cappy and Pyrithione Zinc
This long history of safety and the effectiveness of Pyrithione Zinc in general, and the long history of it being used by pediatricians is what led us to chose it as our Active Ingredient for our Medicated Shampoo and Body Wash.
Federal Register of FDA (1982) “Proposed Rules” for “OTC Drug Products for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis; Establishment of a monograph” p.54664-54666
Understanding the dandruff scalp before and after treatment: an in vivo Raman spectroscopic study. – Bonnist EY, Pudney PD, Weddell LA, Campbell J, Baines FL, Paterson SE, Matheson JR., Int J Cosmet Sci. 2014 Aug;36(4):347-54. doi: 10.1111/ics.12132. Epub 2014 May 14
Federal Register of FDA (1986) “Tentative Final Monograph” for “OTC Drug Products for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis; Establishment of a monograph”p.27350-27351
Above from: Federal Register of FDA (1982) “Proposed Rules” for “OTC Drug Products for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis; Establishment of a monograph” p.54664-54666