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STUDY SUMMARY FOR THE STUDY PROPONENT

Cottonique Clinical Study

Cottonique underwear was found to be clearly superior to another underwear brand, also labeled “hypoallergenic” and “100% cotton” for subjects with underwear allergy. The study was done late last year by dermatologist investigators.

At a Clinical and Research Center using a hard-nosed form of scientific study called double blind randomized controlled trial. The subjects, who believed they were allergic to their underwear, when examined had rashes that were found at the underwear areas. They were a varied multi-heritage group, with skin phototypes ranging from II to V.

To confirm that they had underwear allergy, they were first given a 5-day skin testing procedure where 98 allergy causing chemicals (allergens) were applied in test patches to their skin, kept firmly in place for 48 hours, then removed.

The skin test sites were then examined for reactions, up to 2 days after patch removal. At least one positive reaction to any allergen known to be present in underwear (used in making the textile, like formaldehyde resins and dyes or of the article of clothing, like elastics its accessories, like metal closures; the laundry soap; or fabric softener), confirmed underwear allergy. These were the subjects who were assigned randomly (to avoid bias), to Cottonique or to the Control (comparison underwear).

At baseline, then after each week of using the assigned underwear, for 4 weeks, the skin of the subjects was examined in a “double blind way”. This means that neither the subjects nor the investigators knew which type of underwear the subject was assigned to wear. Investigators asked the subjects what they felt or thought about the underwear’s effect on their skin; and also made their own clinical evaluations. To quantify these subjective evaluations, dermatological instruments were used to measure these effects.

Top skin (using bra/undershirt) or Bottom (panty/brief) instrument readings between baseline and the end of the study, uniformly showed Cottonique underwear users to have: declines in redness, and in skin darkening, which are signs of the inflammation of underwear dermatitis. Most of those using the Control underwear had increased readings or redness and pigmentation. Increased thickening (from hydration) of the outermost layer of the skin means recovery from inflammation. This was significant in top and bottom areas of Cottonique wearers; less significant for the Control wearers.

A basic skin function – to preserve water – was restored after one month in most of the Cottonique wearers while this was not yet restored in most of those wearing the control.

The doctors and patients also had very similar clinical evaluations: Doctors reported moderate to marked improvement in 88% of Cottonique subjects, and 32% improvement in Control wearers. Patients on Cottonique vs. Control rates as moderated, marked and complete improvement as follows:

Skin lightening is a slow process, so the last rating is understandable, although the trend based on the other ratings, is for Cottonique wearers to eventually lighten faster than Control underwear users.

A product that pays attention to the removal of formaldehyde resins, dyes, metal accessories; use carefully chosen, or sewn on elastic materials (described by Cottonique in their product claims) may be of help to people with underwear
allergy
.

Vermen M. Verallo-Rowell, M.D.