JOURNAL OF COSMETIC SCIENCE 256 which is most susceptible to comedones and acne and uses the test material in an expected manner. A positive and negative control is not required because each subject serves as its own control. Statistical analysis compares pretreatment baseline lesion counts with post- treatment lesion counts. REFERENCES (1) A. M. Kligman and O. H. Mills, Acne cosmetic, Arch. Dermatol., 106, 893–897 (1972). (2) A. M. Kligman and T. Kwong, An improved rabbit ear model for assessing comedogenic substances, Br. J. Dermatol., 100, 699–702 (1979). (3) W. E. Morris and S. C. Kwan, Use of the rabbit ear model in evaluating the comedogenic potential of cosmetic ingredients, J. Soc. Cosmet. Chem., 34, 215–225 (1983). (4) J. E. Fulton, Comedogenicity and irritancy of commonly used ingredients in skin care products, J. Soc. Cosmet. Chem., 40, 321–333 (1989). (5) J.E. Fulton Jr, S. R. Pay, and J. E. Fulton 3rd, Comedogenicity of current therapeutic products, cosmet- ics, and ingredients in the rabbit ear, J. Am. Acad. Dermatol., 10, 96–105 (1984). (6) O. H. Mills and A. M. Kligman, Human model for assessing comedogenic substances, Arch. Dermatol., 118, 903–905 (1982). (7) P. G. Engasser, A. M. Kligman, P. Lazar, J. J. Leyden, P. E. Pochi, A. R. Shalita, and J. S. Strauss, Consensus statement. American Academy of Dermatology Invitational Symposium on Comedogenicity. J. Amer. Acad. Dermatol., 20, 272–277 (1989). (8) Z. D. Draelos and J. C. DiNardo, A re-evaluation of the comedogenicity concept, J. Am. Acad. Dermatol., 54, 507–512 (2006).
J. Cosmet. Sci., 68, 257–269 ( July/August 2017) 257 Formulation of chitosan patch incorporating Artocarpus altilis heartwood extract for improving hyperpigmentation JUTATIP KWANKAEW, PREEYAWASS PHIMNUAN, SOMBAT WANAUPPATHAMKUL, and JARUPA VIYOCH Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Center of Excellence for Innovation in Chemistry, Naresuan University, Phitsanulok, 65000 Thailand (J.K., P.P., J.V.), and International Laboratories Corp. Ltd., Sadhupradist Road, Chongnonsi, Yannawa, Bangkok, 10120 Thailand (S.W.) Accepted for publication June 24, 2017. Synopsis Artocarpus altilis heartwood extract contains the bioactive compound artocarpin which exhibits melanogenesis inhibitory activity. However, the extract has poor solubility which affects the skin permeability of the compound. A chitosan hydrogel patch incorporating A. altilis heartwood extract was formulated to enhance the delivery of an amount of artocarpin suffi cient for depigmenting the skin. The extract was prepared as an o/w microemulsion before blending with an aqueous solution of chitosan. The hydrogel patch was formulated by blending in a 1:1 ratio by weight of 4% w/w chitosan solution and 0.04% w/w extract microemulsion which provides optimal values of the mechanical properties of the patch. The release of artocarpin from the formulated patch (artocarpin content, 0.07 mg/cm2) exhibited two phases the rapid rate (0–15 min) averaged 0.73 μg/min/mm2, and the slow rate (15–240 min) averaged 0.02 μg/min/mm2. The formulated patches signifi cantly improved the hyperpigmented area of the subjects after 3 weeks of application. No adverse events were observed. The results indicate that the formulated chitosan hydrogel patch delivers an effective amount of incorporated artocarpin depigmenting action. INTRODUCTION Artocarpus altilis belongs to the Moraceae family. This evergreen tree, called Sa-Kae in Thai, is found throughout the tropical areas of Southeast Asia and has long been used in traditional folk medicines. Several studies have shown that A. altilis heartwood extract contains phenolic compounds with the ability to inhibit the activity of tyrosinase (1–3), a key enzyme for melanin synthesis. Recent studies have identifi ed artocarpin as a major compound in A. altilis heartwood extract (4–8). The artocarpin in the extract decreases melanin production of B16F1 melanocytes (4,5) and exhibits skin depigmenting effects on the ultraviolet B (UVB)-induced hyperpigmented dorsal skin of C57BL/6 mice (4). Address all correspondence to Jarupa Viyoch at jarupav@nu.ac.th, jarupaviyoch4@yahoo.com.
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NON-COMEDOGENIC AND NON-ACNEGENIC CLAIM SUBSTANTIATION 255 Subjects must have not more than 25 facial lesions, which are predominately open and closed comedones. A board-certifi ed dermatologist evaluates the lesions on the face and the results are recorded. Typically, the subject uses the test material on the face for 4–6 weeks. For a 4-week trial, evaluations occur after 2 weeks (optional) and 4 weeks of test material use, whereas for a 6-week trial, evaluations occur after 3 weeks (optional) and 6 weeks of test material use. A board-certifi ed dermatologist evaluates the lesions on the face and the results are recorded. Differences between baseline and interim or fi nal evaluations are considered statistically signifi cant if the probability of obtaining the results by chance is 0.050 using analysis of variance and/or t-test statistical analysis. BENEFITS The in-use clinical trial is a better clinical test than the follicular biopsy and a more pre- dictive test than the follicular biopsy. Like the follicular biopsy model, the in-use clinical trial is human based. However, the in-use clinical trial is the gold standard for comedogenicity because it uses the test material in the manner expected and, it uses the skin of the face, which is more susceptible to comedones and acne. In this regard, the in-use clinical trial is similar to acne trials used to support approval of acne medications by the Food and Drug Administration. A positive control, a material known to cause comedones, and a negative control, a material known not to cause comedones, are not needed because each subject at baseline serves as their own control. Each subject can generate comedones because they must have comedones to qualify for the trial. Thus, each subject enters the trial with the capacity to generate comedones. Consequently, a positive control is not necessary. Indeed, one could argue that including a positive control would be in confl ict with the principles of Good Clinical Practice as described in the World Medical Association’s Declaration of Helsinki (as amended). Other examples of a clinical trial in which a positive control is unethical and inhuman are allergy trials, such as photoallergy. In conclusion, the in-use clinical trial is a better model than the follicular biopsy trial, based on facial skin instead of back skin, and based on the use of the test material in a manner intended. The in-use clinical trial is the gold standard. RISKS The primary risk of the in-use clinical trial is the expense. Conducting an in-use clinical trial is more expensive than the follicular biopsy model, which is why some companies do not conduct in-use clinical trials. CONCLUSIONS In conclusion, the in-use clinical trial is the gold standard when determining comedo- genicity of an ingredient or product. The follicular biopsy model has defi ciencies com- pared with the in-use clinical trial, and the rabbit model has defi ciencies compared with the follicular biopsy model. Although more expensive, the in-use clinical trial uses the face,
JOURNAL OF COSMETIC SCIENCE 256 which is most susceptible to comedones and acne and uses the test material in an expected manner. A positive and negative control is not required because each subject serves as its own control. Statistical analysis compares pretreatment baseline lesion counts with post- treatment lesion counts. REFERENCES (1) A. M. Kligman and O. H. Mills, Acne cosmetic, Arch. Dermatol., 106, 893–897 (1972). (2) A. M. Kligman and T. Kwong, An improved rabbit ear model for assessing comedogenic substances, Br. J. Dermatol., 100, 699–702 (1979). (3) W. E. Morris and S. C. Kwan, Use of the rabbit ear model in evaluating the comedogenic potential of cosmetic ingredients, J. Soc. Cosmet. Chem., 34, 215–225 (1983). (4) J. E. Fulton, Comedogenicity and irritancy of commonly used ingredients in skin care products, J. Soc. Cosmet. Chem., 40, 321–333 (1989). (5) J.E. Fulton Jr, S. R. Pay, and J. E. Fulton 3rd, Comedogenicity of current therapeutic products, cosmet- ics, and ingredients in the rabbit ear, J. Am. Acad. Dermatol., 10, 96–105 (1984). (6) O. H. Mills and A. M. Kligman, Human model for assessing comedogenic substances, Arch. Dermatol., 118, 903–905 (1982). (7) P. G. Engasser, A. M. Kligman, P. Lazar, J. J. Leyden, P. E. Pochi, A. R. Shalita, and J. S. Strauss, Consensus statement. American Academy of Dermatology Invitational Symposium on Comedogenicity. J. Amer. Acad. Dermatol., 20, 272–277 (1989). (8) Z. D. Draelos and J. C. DiNardo, A re-evaluation of the comedogenicity concept, J. Am. Acad. Dermatol., 54, 507–512 (2006).

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