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Recall phenomenon in site of previous drug extravasation
P436
P438
Ceramide insufficiency in dandruff/seborrheic dermatitis stratum corneum is reversed by potentiated micronized platelet pyrithione zinc shampoo treatment Kevin Mills, PhD, The Procter & Gamble Company, Cincinnati, OH, United States; Elaine Suszcynsky-Meister, MS, Procter & Gamble, Cincinnati, OH, United States; Erica Kincaid, MS, Procter & Gamble, Cincinnati, OH, United States; Megan Copas, Procter & Gamble, Cincinnati, OH, United States Background: Previous electron microscopic analysis of stratum corneum (SC) from lesional scalp sites of dandruff/seborreheic dermatitis (D/SD) sufferers revealed numerous structural abnormalities, including disordered lipid membrane lamellae. Similar abnormalities were noted in nonlesional areas of the scalp, suggesting that an underlying epidermal barrier lipid abnormality may play a role in the pathogenesis of D/SD.
The rate of release of active ingredients from a novel wash-off or leave-on sodium sulfacetamide 10%/sulfur 5% emollient foam Mark Trumbore, PhD, Cumberland, RI, United States
Objective: To determine whether SC structural abnormalities in D/SD are accompanied by altered lipid composition and whether lipid composition could be affected by treatment with a micronized platelet pyrithione zinc (PTZ)econtaining shampoo. Methods: Levels of the three major SC lipid classes, free fatty acids (FA), cholesterol (CHOL), and ceramides (CER) were examined in tape strips from lesional and nonlesional areas of the scalps of D/SD sufferers, and compared to levels in healthy subjects. Lipids were separated by HPTLC, quantitated by comparison with authentic standards, and normalized to total SC protein. Statistical analysis used the Wilcoxon rank sum test. Tests were 2-sided, and differences considered significant if P values were # .05.
Rosacea is a common chronic skin disease of the face. Although it is most frequently observed in fair skinned individuals, it can also be found in Asian and African American populations. Rosacea inflicts both men and women with onset typically occurring after age 30. Sodium sulfacetamide/sulfur is a common first-line treatment for rosacea. Recently, a novel sodium sulfacetamide/sulfur emollient foam was introduced. This product is unique as it is the first to be indicated as both a wash-off and leave-on product. In order for a product to successfully function as both a washoff and leave-on product it must rapidly and efficiently release its active ingredients to the skin while at the same time provide sufficient substantivity to keep the active ingredient in skin contact. Previous work has shown that the sodium sulfacetamide/sulfur foam has sufficient substantivity to provide moisturization to the skin for at least 2 hours postapplication. This study reports on the release of actives from sodium sulfacetamide/sulfur emollient foam following application of the product. 100% is supported by Onset Therapeutics.
Results: In D/SD lesional SC, the baseline content of free FA, CHOL, and CER were all significantly diminished relative to healthy control; moreover, there were significant differences with respect to specific CER subtypes, with CER 1 (EOS) and CER 3 (NP) being especially diminished: CER 1 median 2.0 ng/mg protein (interquartile range [iq] range 3.0; n ¼ 21) versus normal of 4.0 ng/mg (iq range 9.8; n ¼ 18; P ¼.0183). For CER 3, median 3.3 ng/mg (iq range 5.8), versus normal of 8.6 ng/mg (iq range 20.7; P ¼ .0074). A 6-week course of treatment with a potentiated micronized platelet PTZ shampoo, which significantly resolved D/SD lesions, resulted in restoration of total measured SC CER to levels comparable to healthy subject SC. The restoration of CER occurred in the absence of any significant changes in either total FA or CHOL, demonstrating a specific effect of treatment on the ratio of CER to other barrier lipids. These data support the importance of CER to the maintenance of barrier function, and suggest that D/SD is a disorder characterized by abnormal epidermal CER composition. 100% sponsored by the Procter & Gamble Company.
P439
P437 The treatment of hyperkeratosis with a new, 30% urea emollient foam: A series of case studies Jay Goldstein, MD, Natick, MA, United States; Ronald Gurge, PhD, Collegium Pharmaceutical, Cumberland, RI, United States Background: Hyperkeratosis is a skin condition in which patients experience a variety of signs and symptoms including scaling, roughness, dryness, cracks/fissures, erythema, and pruritus. Topical keratolytic therapies containing urea are commonly prescribed as treatments for these conditions; the symptoms of which can lead to a decreased quality of life. However to date, quality of life assessments are lacking in the use of topical urea products in patients. Recently, 30% urea has been incorporated into a new, emollient foam vehicle that has been shown to have many desirable skin-feel, appearance, and aroma attributes. Objective: Examine the clinical effectiveness of a new 30% urea emollient foam product in treating hyperkeratosis and to assess the improvement in the quality of life of patients following treatment. Methods: Physician assessment based on specified symptom sum score (SSSC) system and patient assessment of disease improvement and quality of life based on Skindex-16 at baseline (day 0) and days 14 and 28 of treatment.
Recall phenomenon in site of previous drug extravasation Blanca Diaz-Ley, MD, Hospital Universitario de la Princesa, Madrid, Spain; Javier Sanchez Perez, PhD, Hospital Universitario de La Princesa, Madrid, Spain; Javier Fraga, PhD, Hospital Universitario de La Princesa, Madrid, Spain; Amaro Diez, PhD, Hospital Universitario de La Princesa, Madrid, Spain Introduction: Chemotherapy-induced recall dermatitis is a phenomenon whereby the administration of a chemotherapeutic agent induces an inflammatory reaction at a previous injury site. Only two cases have been reported describing a chemotherapy-recall phenomenon on a previously damaged skin because of extravasation. We report a unique case of a recall phenomenon, an uncommon skin reaction, induced by docetaxel. Case report: A 38-year-old female was diagnosed as having breast cancer. After receiving radical mastectomy and axilary node dissection, she underwent a chemotherapy treatment with docetaxel (100 mg/m2) every 3 weeks. Four days after the seventh cycle of docetaxel, she developed a well defined, erythematous, and slightly infiltrative plaque at the infusion site (right arm) because of docetaxel extravasation which healed after 2 weeks. However, 2 days after receiving eighth docetaxel cycle, infused on the other arm (left arm), she developed recurrent erythema and induration at the peripheral limits of the previous injured area located on the right arm. Two biopsies were performed, the first one was taken after the extravasation injury, and the second one after the reactivation of the previous damaged area. Both of them revealed epidermal dysmaduration with dyskeratotic keratinocytes, basal vacuolar changes and eccrine squamous syringometaplasia, features compatible with the effects of chemotherapeutic agents.
Results and conclusions: The 30% urea emollient foam formulation significantly reduced the signs and symptoms of hyperkeratosis as assessed by the SSSC. Patients reported a significant improvement in quality of life as measured by Skindex-16. Overall, patients were satisfied with their clinical improvement and very satisfied with the aesthetic attributes of the 30% urea foam (ease of application, very satisfactory odor, lack of sticky or greasy feel and very satisfactory overall product feel). Based upon these results, we conclude that the 30% urea emollient foam delivered the keratolytic and moisturization properties of urea in an aesthetically pleasing formulation.
Discussion: Recall phenomenon is a rare and interesting entity as its mechanism is currently unknown. The most well known recall phenomenon is radiation-recall, being other types of recall dermatitis rare reactions. Moreover, as far as we know, chemotherapy-induced recall reaction in an injured tissue because of extravasation has only been reported twice in medical literature, corresponding both cases to doxorubicin extravasations reactions. Docetaxel associated recall dermatitis, as well as recall reactions caused by other members of the taxane group, are well documented in the literature. However, none among the docetaxel-recall reactions reported are related to previous drug extravasation. To our knowledge, this is the first case of a docetaxel-recall dermatitis in site of previous extravasation.
100% is sponsored by Onset Therapeutics.
Commercial support: None identified.
FEBRUARY 2008
J AM ACAD DERMATOL
AB41
P438
Ceramide insufficiency in dandruff/seborrheic dermatitis stratum corneum is reversed by potentiated micronized platelet pyrithione zinc shampoo treatment Kevin Mills, PhD, The Procter & Gamble Company, Cincinnati, OH, United States; Elaine Suszcynsky-Meister, MS, Procter & Gamble, Cincinnati, OH, United States; Erica Kincaid, MS, Procter & Gamble, Cincinnati, OH, United States; Megan Copas, Procter & Gamble, Cincinnati, OH, United States Background: Previous electron microscopic analysis of stratum corneum (SC) from lesional scalp sites of dandruff/seborreheic dermatitis (D/SD) sufferers revealed numerous structural abnormalities, including disordered lipid membrane lamellae. Similar abnormalities were noted in nonlesional areas of the scalp, suggesting that an underlying epidermal barrier lipid abnormality may play a role in the pathogenesis of D/SD.
The rate of release of active ingredients from a novel wash-off or leave-on sodium sulfacetamide 10%/sulfur 5% emollient foam Mark Trumbore, PhD, Cumberland, RI, United States
Objective: To determine whether SC structural abnormalities in D/SD are accompanied by altered lipid composition and whether lipid composition could be affected by treatment with a micronized platelet pyrithione zinc (PTZ)econtaining shampoo. Methods: Levels of the three major SC lipid classes, free fatty acids (FA), cholesterol (CHOL), and ceramides (CER) were examined in tape strips from lesional and nonlesional areas of the scalps of D/SD sufferers, and compared to levels in healthy subjects. Lipids were separated by HPTLC, quantitated by comparison with authentic standards, and normalized to total SC protein. Statistical analysis used the Wilcoxon rank sum test. Tests were 2-sided, and differences considered significant if P values were # .05.
Rosacea is a common chronic skin disease of the face. Although it is most frequently observed in fair skinned individuals, it can also be found in Asian and African American populations. Rosacea inflicts both men and women with onset typically occurring after age 30. Sodium sulfacetamide/sulfur is a common first-line treatment for rosacea. Recently, a novel sodium sulfacetamide/sulfur emollient foam was introduced. This product is unique as it is the first to be indicated as both a wash-off and leave-on product. In order for a product to successfully function as both a washoff and leave-on product it must rapidly and efficiently release its active ingredients to the skin while at the same time provide sufficient substantivity to keep the active ingredient in skin contact. Previous work has shown that the sodium sulfacetamide/sulfur foam has sufficient substantivity to provide moisturization to the skin for at least 2 hours postapplication. This study reports on the release of actives from sodium sulfacetamide/sulfur emollient foam following application of the product. 100% is supported by Onset Therapeutics.
Results: In D/SD lesional SC, the baseline content of free FA, CHOL, and CER were all significantly diminished relative to healthy control; moreover, there were significant differences with respect to specific CER subtypes, with CER 1 (EOS) and CER 3 (NP) being especially diminished: CER 1 median 2.0 ng/mg protein (interquartile range [iq] range 3.0; n ¼ 21) versus normal of 4.0 ng/mg (iq range 9.8; n ¼ 18; P ¼.0183). For CER 3, median 3.3 ng/mg (iq range 5.8), versus normal of 8.6 ng/mg (iq range 20.7; P ¼ .0074). A 6-week course of treatment with a potentiated micronized platelet PTZ shampoo, which significantly resolved D/SD lesions, resulted in restoration of total measured SC CER to levels comparable to healthy subject SC. The restoration of CER occurred in the absence of any significant changes in either total FA or CHOL, demonstrating a specific effect of treatment on the ratio of CER to other barrier lipids. These data support the importance of CER to the maintenance of barrier function, and suggest that D/SD is a disorder characterized by abnormal epidermal CER composition. 100% sponsored by the Procter & Gamble Company.
P439
P437 The treatment of hyperkeratosis with a new, 30% urea emollient foam: A series of case studies Jay Goldstein, MD, Natick, MA, United States; Ronald Gurge, PhD, Collegium Pharmaceutical, Cumberland, RI, United States Background: Hyperkeratosis is a skin condition in which patients experience a variety of signs and symptoms including scaling, roughness, dryness, cracks/fissures, erythema, and pruritus. Topical keratolytic therapies containing urea are commonly prescribed as treatments for these conditions; the symptoms of which can lead to a decreased quality of life. However to date, quality of life assessments are lacking in the use of topical urea products in patients. Recently, 30% urea has been incorporated into a new, emollient foam vehicle that has been shown to have many desirable skin-feel, appearance, and aroma attributes. Objective: Examine the clinical effectiveness of a new 30% urea emollient foam product in treating hyperkeratosis and to assess the improvement in the quality of life of patients following treatment. Methods: Physician assessment based on specified symptom sum score (SSSC) system and patient assessment of disease improvement and quality of life based on Skindex-16 at baseline (day 0) and days 14 and 28 of treatment.
Recall phenomenon in site of previous drug extravasation Blanca Diaz-Ley, MD, Hospital Universitario de la Princesa, Madrid, Spain; Javier Sanchez Perez, PhD, Hospital Universitario de La Princesa, Madrid, Spain; Javier Fraga, PhD, Hospital Universitario de La Princesa, Madrid, Spain; Amaro Diez, PhD, Hospital Universitario de La Princesa, Madrid, Spain Introduction: Chemotherapy-induced recall dermatitis is a phenomenon whereby the administration of a chemotherapeutic agent induces an inflammatory reaction at a previous injury site. Only two cases have been reported describing a chemotherapy-recall phenomenon on a previously damaged skin because of extravasation. We report a unique case of a recall phenomenon, an uncommon skin reaction, induced by docetaxel. Case report: A 38-year-old female was diagnosed as having breast cancer. After receiving radical mastectomy and axilary node dissection, she underwent a chemotherapy treatment with docetaxel (100 mg/m2) every 3 weeks. Four days after the seventh cycle of docetaxel, she developed a well defined, erythematous, and slightly infiltrative plaque at the infusion site (right arm) because of docetaxel extravasation which healed after 2 weeks. However, 2 days after receiving eighth docetaxel cycle, infused on the other arm (left arm), she developed recurrent erythema and induration at the peripheral limits of the previous injured area located on the right arm. Two biopsies were performed, the first one was taken after the extravasation injury, and the second one after the reactivation of the previous damaged area. Both of them revealed epidermal dysmaduration with dyskeratotic keratinocytes, basal vacuolar changes and eccrine squamous syringometaplasia, features compatible with the effects of chemotherapeutic agents.
Results and conclusions: The 30% urea emollient foam formulation significantly reduced the signs and symptoms of hyperkeratosis as assessed by the SSSC. Patients reported a significant improvement in quality of life as measured by Skindex-16. Overall, patients were satisfied with their clinical improvement and very satisfied with the aesthetic attributes of the 30% urea foam (ease of application, very satisfactory odor, lack of sticky or greasy feel and very satisfactory overall product feel). Based upon these results, we conclude that the 30% urea emollient foam delivered the keratolytic and moisturization properties of urea in an aesthetically pleasing formulation.
Discussion: Recall phenomenon is a rare and interesting entity as its mechanism is currently unknown. The most well known recall phenomenon is radiation-recall, being other types of recall dermatitis rare reactions. Moreover, as far as we know, chemotherapy-induced recall reaction in an injured tissue because of extravasation has only been reported twice in medical literature, corresponding both cases to doxorubicin extravasations reactions. Docetaxel associated recall dermatitis, as well as recall reactions caused by other members of the taxane group, are well documented in the literature. However, none among the docetaxel-recall reactions reported are related to previous drug extravasation. To our knowledge, this is the first case of a docetaxel-recall dermatitis in site of previous extravasation.
100% is sponsored by Onset Therapeutics.
Commercial support: None identified.
FEBRUARY 2008
J AM ACAD DERMATOL
AB41