LIP BALM: SUMMARY OF THREE DERMATOLOGICAL STUDIES 3 ingredients and using minimal concentrations of ingredients known to be irritants. In addition, the use of ingredients known to be sensitizing or revulsive/hyperaemic/vasodilator agents should be avoided. Thought should be given to the use of ingredients which may play a role in the reconstruction of the epidermal barrier, and the use of fragrances and dyes should be carefully considered (6). Functionally, for the study of a product intended for sensitive skin, volunteers with a clinical diagnosis of sensitive skin are recruited. A method used for assessing the level of skin sensitivity is the “stinging test,” which is a straightforward, reliable way to identify the required study population (7). Data generated from three studies with the prototype lip balm are summarized herein. Study 1 was designed to demonstrate the absence of irritant (primary and cumulative dermal irritation) and allergic (sensitization) potential of the product. Study 2 was de- signed to demonstrate the absence of photoirritation or photosensitization of the product when exposed to UVA radiation through the phototest assay. The objective of Study 3 was to prove the suitability, under normal conditions of use, of the product for people with a diagnosis of sensitive skin. MATERIALS AND METHODS The three studies described herein were sponsored by GlaxoSmithKline Brazil Ltda. and conducted at the Medcin Instituto da Pele Ltda. clinical research site in São Paulo, Brazil. The Medcin Instituto da Pele has a Quality Management System that is in compliance with Good Clinical Practices (GCP) guidelines and Number Standard International Or- ganization for Standardization/International Electrotechnical Commission 17025/2005, which specifi es the general requirements for assessing the qualifi cation of assay and cali- bration laboratories. The quality control is performed in every step of the method described in the protocols to allow the investigation and the accurate assessment of the test product, ensuring the reliability of data analyzed according to standard procedures. The studies were conducted in accordance with GCP regulations, the Declaration of Helsinki, and the Rules on Research Involving Human Subjects (Resolution National Health Council 196/96 and others) per the National Health Council, Brazilian Ministry of Health. The list of ingredients in the study product includes purifi ed water, butyrospermum parkii butter, D-glucose-monohydrate, olus oil, elaeis guineensis oil, glycerin, oryza sativa cera, behenyl alcohol, oryza sativa bran oil, hydrogenated lecithin (hydrogenated phosphatidylcholine), capryloyl glycine, pentylene glycol, caprylyl glycol, hydroxyethyl cellulose, squalane, sodium hydroxide, dehydroxanthan gum, dl-alpha tocopherol, galac- toarabinan, acrylates/C10-30 alkyl acrylate crosspolymer, sodium carbomer, palmitamide monoethanolamine, trisodium ethylenediamine disuccinate, ascorbyl palmitate, ceramide 3, and phytosphingosine. In the observational studies 1 and 2, the product and controls were applied to the volun- teers’ backs under patches and dermatological assessments were performed at specifi ed times per protocols or when there was evidence of positivity (grade 2, 3 or 4 on the ICDRG scale) or an adverse event. The patches were semiocclusive and were comprised of 1 cm in diameter fi lter paper discs (100% cellulose) and Micropore® semipermeable adhesive tape.

JOURNAL OF COSMETIC SCIENCE 4 The study product (undiluted), 0.02 mL, was applied under a patch to the volunteers backs along with the following controls under a separate patch each: • Saline solution • Mineral oil • No product on the fi lter paper disc • Adhesive tape (Micropore® with no fi lter paper disc). During the studies, volunteers were instructed not to move or wet the patches, not to start using new topical products during the assessment period, and not to be exposed to direct sunlight. Volunteers were requested to report the use of any medication or treatment dur- ing the studies. Dermatological assessments for studies 1 and 2 measuring dermal irritability and sensi- tization, photoirritation, and photosensitization, were performed using the scale recom- mended by the ICDRG (2). See Table II. If any evidence of positivity was observed (grade 2, 3, or 4), a new reading was performed after 30 min at rest, and if the evidence remained unchanged, the volunteer was referred to a dermatologist. In the case of positivity evidence confi rmed by the dermatologist, the applica- tion of the sample would be discontinued and a retest would be performed on the volunteer. For these situations, the adverse event was followed up as required until event resolution. If a retest was required, a semiocclusive patch containing the sample suspected of positiv- ity was applied on an application-naive area of the volunteer’s back or forearm. Sample reapplication would be performed on the same day on which the reaction was observed if the reaction was classifi ed as mild in accordance with the ICDRG reading scale. If the reaction was classifi ed as moderate or severe, the sample reapplication was performed in a minimum of 48 h. Readings were performed 24 h after application to determine positivity. Studies 1 and 2 were conducted in healthy volunteers of both genders between 18 and 60 year of age who were classifi ed with skin type as Phototype I–IV per the Fitzpatrick scale, a numerical classifi cation scale, which classifi es a person’s complexion and their tolerance to sunlight and ultraviolet radiation (8). Study 1 consisted of three phases of separate assessments for primary dermal irritation, cumulative dermal irritation, and dermal sensitization. In the primary dermal irritation phase, patches were removed after 2 d (48 h) and the initial assessment was conducted. A second assessment was made 2 d later (96 h) after a patch free interval. Assessments at 48 and 96 h were recorded. In parallel to the primary dermal irritation phase, patches were applied to a separate area of volunteers’ backs to assess cumulative dermal irritation. Volunteers returned for patch Table II ICDRG Scale ICDRG reading Result Grade No lesion Negative 0 Mild erythema Uncertain 1 Clear erythema Positive (+) 2 Erythema + edema + papules Positive (++) 3 Erythema + edema + papules + vesicles Positive (+++) 4