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Investigational Gel Rapidly Clears Actinic Keratosis

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Investigational Gel Rapidly Clears Actinic Keratosis October 2008 • w w w. s k i n a n d a l l e rg y n ew s. c o m Cutaneous Oncology 25 Investigational Gel Rapidly Clears Actinic Keratosis B Y P AT R I C E W E N D L I N G tology practice in Tyler, Texas, and his as- extremities histori- Chicago Bureau sociates randomized 222 patients with 4- cally are more dif- Partial Clearance Rates for AK Lesions 8 visible AK lesions on the arm, shoulder, ficult to treat than C H I C A G O — Topical therapy for 2 or 3 chest, back, or scalp, to one of four treat- scalp lesions, the PEP005 0.05% days with the investigational agent in- ment groups. The primary end point was investigators per- for 3 days 75% genol mebutate, also known as PEP005, partial clearance, defined as the propor- formed an ad hoc provides substantial clearance of actinic tion of patients at day 57 with 75% re- analysis to com- PEP005 0.05% 62% keratosis lesions, according to findings duction in the number of AK lesions iden- pare outcomes in for 2 days from two phase II randomized studies. tified at baseline. patients with scalp “A comparison of efficacy outcomes with Treatment with PEP005 gel once daily and nonscalp le- PEP005 0.025% 56% those of studies of diclofenac, 5-FU [fluo- for 2 or 3 days produced significantly sions, Dr. Michael for 3 days S W E rouracil], and imiquimod shows at least greater lesion clearance in a dose-depen- Freeman of the N L Control vehicle A equivalent clearance of lesions over a much dent manner by all measures and at all dos- Skin Centre, Gold C 22% I for 3 days D shorter period,” Dr. Lawrence Anderson, ing regimens, compared with a control ve- Coast, Australia, E M L one of the current study’s lead investiga- hicle applied once daily for 3 days. and his associates A Notes: Partial clearanceearance rate defined as proportion ofof patients with B O tors, reported at the American Academy of The partial clearance rate was 22% for said in a separate 75% reduction in the number of lesions. Study involved 222 L G Dermatology’s Academy 2008 meeting. vehicle, 56% for ingenol mebutate gel poster. R patients with 4-8 visible lesions. E I V Ingenol mebutate gel has the potential 0.025% for 3 days, 62% for ingenol mebu- Overall, scalp Source: Dr. Anderson E S L to enhance compliance not only by its tate gel 0.05% for 2 days, and 75.4% for in- treatment areas E shorter course of therapy, but also by the genol mebutate 0.05% for 3 days. had a higher com- truncated period of irritation in patients The proportion of patients at day 57 plete clearance rate than nonscalp treat- in 86 patients with lesions limited to the with actinic keratosis (AK), the investiga- with complete clearance, defined as no ment areas (57% vs. 42.4%), although the face or face and scalp. tors suggested. clinically visible AK lesions, was 12%, 40%, gel was better tolerated when applied to At the MTD, 26 of 36 patients (72%) PEP005 is a new class of compound de- 44%, and 54.4%, respectively. nonscalp areas, regardless of concentra- achieved partial clearance and 14 of the 36 rived from the sap of Euphorbia peplus, a All three active treatments were well tol- tion or dosing schedule, the investigators (39%) achieved complete clearance. readily available plant that has been used erated, according to the investigators, one wrote. Ingenol mebutate gel was well tolerat- in Australia for centuries as a traditional of whom was a Peplin employee. The The maximum tolerated dose (MTD) ed across all strengths, with erythema the treatment for skin conditions. The two most common lesion-site reactions on day for face or face and scalp AK was deter- most common lesion site reaction. Three current studies were sponsored by Peplin 57 were erythema, experienced by 34% of mined to be once-daily ingenol mebutate patients experienced four serious adverse Ltd. of Brisbane, Australia, which is de- 162 actively treated patients; flaking or gel 0.025% for 2 days, according to a sec- events, none considered treatment related, veloping PEP005. scaling (29%); and crusting (9%). ond study that evaluated six formulation according to the investigators, one of Dr. Anderson, who is in private derma- Because AK lesions on the trunk and strengths ranging from 0.0025% to 0.025% whom was also a Peplin employee. ■ Ethnicity, Smoking, and BMI May Predict Tanning Dependence B Y S H A R O N W O R C E S T E R ance enhancement, tanners often Ǡ Those who used moderate Southeast Bureau report other benefits, such as (OR 0.27) or high levels (OR 0.36) mood enhancement, and social- of sun protection were less like- anning dependence, some- ization, commonly reported by ly than were those who used low Ttimes called “tanorexia,” is individuals with other types of levels to be tanning dependent. Ǡ common in young adults and can dependencies, Dr. Heckman and M Those who tanned indoors O C be predicted by certain demo- her associates noted. during warm weather were more O T graphic and behavioral variables, Tanning dependence also has O likely to be tanning dependent H P according to a survey of 400 col- similarities to disorders such as K (OR 2.99) than were those who C O lege students. obsessive compulsive disorder T did not use indoor tanning. S I / K More than a quarter (27%) of and eating disorders, thus the A The use of chemical sunless C survey respondents were classi- nickname “tanorexia,” but it is U tanners and the overall rates of A R fied as tanning dependent, and unclear which comparisons are O indoor tanning did not predict B ethnicity, skin type, lack of skin most applicable. © tanning dependence in this study. protective behaviors, tanning be- Prior studies have suggested Tanning dependence bears similarities both to substance use Health-related behaviors that haviors, smoking, and body mass that one possible mechanism for disorder and to eating disorders, thus the nickname “tanorexia.” were linked with tanning depen- index each were found to be sig- tanning dependence is endoge- dence included current smoking, nificant independent predictors nous opioid release during ultra- tion CAGE alcohol evaluation white participants having 7.6-fold with smokers having 1.81 greater of tanning dependence, reported violet radiation (UVR) exposure: and the American Psychiatric As- greater odds than African Ameri- odds of tanning dependence, and Carolyn J. Heckman, Ph.D., of Blinded study participants sociation’s Diagnostic and Statis- cans. Also predictive was moder- obesity, with those considered Fox Chase Cancer Center in demonstrated a preference for tics Manual IV–Text Revision ate skin type, compared with fair obese having lower likelihood of Cheltenham, Pa., and her col- UVR vs. non-UVR tanning beds, substance dependence criteria. and dark skin. Those with Fitz- being dependent (odds ratio 0.34). leagues (Am. J. Health Behav. and UVR exposure was associat- Participants, who had a mean patrick type III and IV skin had The findings may offer new 2008;32:451-64). ed with a more relaxed and less age of 21 years and were mostly the highest risk: Sixteen percent avenues for research as well as The findings could assist clini- tense mood in those studies. Fur- women (75%), were asked ques- of those with type I, 21% with skin protection and skin cancer cians in identifying individuals thermore, in at least one other tions about tanning behaviors type II, 39% with type III, 32% prevention interventions, the in- who are tanning dependent or study, the preference for UVR such as “Do you think you need with type IV, and 4% with type V vestigators concluded, but they who are at risk of becoming de- tanning beds was reduced with to spend more and more time in skin were tanning dependent. also noted that “not all tanning pendent, the investigators said. increasing doses of the opioid the sun to maintain your perfect Several exposure and skin pro- behavior or even frequent be- In the article, which is now in antagonist naltrexone. tan?” and “Does your belief that tection factors were found to pre- havior should be seen as indica- press, the investigators stated that In the current study, which was tanning can cause skin cancer dict tanning dependence: tive of tanning dependence.” tanning dependence has a num- sponsored by the National Can- keep you from spending time in Ǡ Those with highest level of Nonetheless, they expressed ber of similarities to substance cer Institute, tanning dependence the sun or going to tanning beds?” summer sunbathing were more concern regarding the finding use, including higher prevalence was assessed using measures de- Of the 400 individuals sur- likely to be tanning dependent that about 40% of respondents among youth, an initial percep- veloped to evaluate more tradi- veyed, 106 (27%) were classified (odds ratio 7.5) than were those had used tanning beds, with a tion that the behavior is image tional addictive behaviors such as tanning dependent by one or with the lowest level. mean age of 17 years at first tan- enhancing, and high health risks as substance use, which were both of the two scales used, the Ǡ Respondents who had the ning and a mean number of life- and disregard for warnings about adapted for the purpose of as- investigators found. highest number of sunburns time uses of 57. This is alarming, those risks.
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