Patient Assessment of Foam Attributes from the Tazarotene Foam 0.1% Phase III Trials and Potential Impact on Patient Compliance_Schreiber et al 2018 Final Pa�ent Assessment of Foam A�ributes from the Tazarotene Foam, 0.1%, Phase III Trials and Poten�al Impact on Pa�ent Compliance Rhonda Schreiber BScN, MSSL; Caitlin Lewis, PhD; Kaytiana Crane BS Tazarotene is the only re�noid approved for use in a foam vehicle, and as such, is uniquely situated to offer the benefits of such a formula�on to acne sufferers. W hilst its safety and efficacy are well established, the data presented here are the first to examine pa�ent preference for the foam vehicle compared to other formula�ons and intent to comply with physician instruc�ons. It has been previously well established that topical vehicle impacts not only safety, efficacy, and tolerability, but also pa�ent preference and therefore adherence to treatment protocols.3,4 This data clearly shows that the foam formula�on rated strongly in a range of proper�es which other studies have found to be important to pa�ents when choosing a topical vehicle.2 In addi�on, the foam was rated the most favorable formula�on by 51% of study par�cipants, with the next highest being cream at 17%. Perhaps most significantly, when par�cipants were asked if they would use the foam product once a day for 12 weeks, 85% said they would comply 75-100% of the �me. It is noted that no direct data has been collected on compliance rates amongst users of tazarotene foam, 0.1%. However, the data presented here strongly suggest that the favorable a�ributes the foam were preferred by par�cipants and, as has been noted in other studies, posi�ve pa�ent preference can lead to increased compliance and therefore be�er treatment outcomes for acne sufferers. 1. Demircay Z, Seckin D, Senol A, Demir F. Eur J Dermatol. 2008 Mar-Apr;18(2):181-4. 2. Dréno B, Thiboutot D, Gollnick H, Finlay AY, Layton A, Leyden JJ, Leutenegger E, Perez M; Global Alliance to Improve Outcomes in Acne. Int J Dermatol. 2010 Apr;49(4):448-56. 3. Baldwin, HE Dermatol Ther. 2006 Jul-Aug;19(4): 224-236. 4. Kircik LH. J Drugs Dermatol. 2011 Jun;10(6):s17-23. 5. Eastman WJ, Malahias S, Delconte J, DiBenede� D. Cu�s. 2014 Jul;94(1):46-53. 6. Tan X, Feldman, SR, et al. Expert Opin Drug Deliv. 2012 Oct;9(10):1263-71. 7. Smith JA, Narahari S, Hill D, Feldman SR. Expert Opin Drug Saf. 2016 Jan;15(1):99-103 8. Feldman SR, Werner CP, Alió Saenz AB. J Drugs Dermatol. 2013 Apr;12(4):438-46. 9. Epstein EL, Stein Gold L. Clin Cosmet Inves�g Dermatol. 2013 May 14;6:123-5. 10. Data on file; Mayne Pharma. Acne vulgaris is a common chronic disease which can affect a pa�ent’s physical appearance and psychosocial func�on and o�en requires long term use of topical medica�ons. 1,3 While topical delivery of drugs in the treatment of dermatological condi�ons is an obvious front-line strategy, pa�ent compliance is a known recurring barrier to treatment success.2,3 Lack of adherence to treatment strategy has been linked with both pa�ent dissa�sfac�on and poor treatment outcomes.2 Adherence to treatment is governed by a range of factors including financial and clinical considera�ons. Recent research also shows that pa�ent vehicle preference is an important, but o�en overlooked, factor in maintaining compliance.3-6 A worldwide study found that poor adherence occurs in 40% of pa�ents receiving topical treatment for acne.2 Topical treatments for acne include formula�ons such as creams, lo�ons, ointments, gels, solu�ons and foams. Vehicle choice has an impact not only on drug delivery and potency, but also cosme�c and pa�ent percep�on a�ributes.4 Studies show that common concerns affec�ng pa�ent adherence to topical drug regimens in chronic skin condi�ons are the ability to be used all the �me, speed of absorp�on/disappearance, spreadability, ease of applica�on, messiness, ability to moisturize, and lack of greasiness, s�ckiness, and scent. 3,5 A�er drug efficacy, pa�ent preference should be a primary considera�on in choosing topical vehicles.3 Tazarotene foam, 0.1% is the only re�noid in a foam vehicle, and it is well established as a safe, effec�ve, and well tolerated topical treatment for acne vulgaris.7-9 The data presented here highlight the results of pa�ent preference ques�onnaires, administered at the end of the tazarotene foam Phase III trials, related to evalua�on of the foam vehicle as well as other formula�ons previously used by study subjects for acne treatment.10 BACKGROUND • Evaluate pa�ent preference for topical vehicle a�ributes. • Examine the link between pa�ent preferences and adherence to treatment strategy. AIMS • Two mul�center, randomized, double blind, vehicle controlled, parallel group Phase III studies were carried out, with 1485 pa�ents randomized in a 1:1 ra�o into two treatment groups either tazarotene foam, 0.1% (744) or vehicle foam (741). • Par�cipants were aged 12-45 years with moderate to severe acne vulgaris. • Study subjects were required to apply foam to the face once daily for 12 weeks and were permi�ed to apply to the trunk as well. • Efficacy, safety, and tolerability assessments were carried out at baseline and at weeks 2, 4, 8, and 12. • At the week 12 (final) visit a pa�ent ques�onnaire was administered which incorporated ques�ons about formula�on a�ributes, preference for treatment vehicle, and intent to adhere to treatment. • The ques�onnaire results presented here have been integrated across the two studies and contain data for both tazarotene foam, 0.1% and vehicle-only cohorts. CONCLUSIONS METHODS REFERENCES RESULTS At the conclusion of the Phase III studies, par�cipants were given a ques�onnaire to complete regarding their personal preferences and experiences with the foam vehicle compared to other formula�ons they had used. Approximately 94% of study subjects par�cipated in the ques�onnaire. They were unaware as to whether they were ra�ng vehicle or tazarotene foam. The most per�nent aspects are presented here. Integrated Intent-to-Treat Analysis Set N=1485, n(%) 100% 75-99% 50-74% 25-49% �24% Does Not Apply Not Answered Foam 763 (51) 495 (33) 61 (4) 20 (1) 23 (2) 30 (2) 93 (6) Gel 365 (25) 336 (23) 131 (9) 53 (4) 26 (2) 479 (32) 95 (6) Cream 481 (32) 443 (30) 138 (9) 48 (3) 30 (2) 250 (17) 95 (6) Lo�on 422 (28) 355 (24) 123 (8) 61 (4) 27 (2) 401 (27) 96 (6) Solu�on 338 (23) 315 (21) 132 (9) 57 (4) 36 (2) 512 (34) 95 (6) Integrated Intent-to-Treat Analysis Set N=1485, n(%) Liked Best 2nd Best 3rd Best 4th Best Liked Least Does Not Apply Not Answered Foam 754 (51) 263 (18) 140 (9) 83 (6) 103 (7) 44 (3) 98 (7) Cream 246 (17) 372 (25) 260 (18) 152 (10) 62 (4) 292 (20) 101 (7) Gel 136 (9) 201 (14) 170 (11) 135 (9) 150 (10) 594 (40) 99 (7) Lo�on 120 (8) 237 (16) 248 (17) 186 (13) 108 (7) 485 (33) 101 (7) Solu�on 75 (5) 155 (10) 165 (11) 189 (13) 176 (12) 622 (42) 103 (7) 0% 10% 20% 30% 40% 50% 60% Liked Best 2nd Best 3rd Best 4th Best Liked Least Foam Gel Cream Lo�on Solu�on Study Popula�on Gender n (%) Age n(%) Male 729 (49) 12-17 years 860 (58) Female 756 (51) 18-25 years 428 (29) 26-35 years 143 (10) 36-45 years 54 (4) Integrated Intent-to-Treat Analysis Set N=1485, n(%) Excellent Good Fair Poor Very Poor Not Answered Easy to Apply 856 (58) 381 (26) 127 (9) 20 (1) 8 (1) 93 (6) Spreadability 764 (51) 440 (30) 152 (10) 28 (2) 8 (1) 93 (6) Absorbs Quickly 638 (43) 438 (29) 229 (15) 67 (5) 17 (1) 96 (6) Lack of Residue 392 (26) 499 (34) 330 (22) 113 (8) 58 (4) 93 (6) Does not Feel Greasy 505 (34) 411 (28) 291 (20) 133 (9) 51 (3) 94 (6) Fragrance-Free 515 (35) 384 (26) 312 (21) 128 (9) 53 (4) 93 (6) Lack of S�ckiness 603 (41) 432 (29) 262 (18) 75 (5) 19 (1) 94 (6) Moisturizing 126 (8) 391 (26) 479 (32) 250 (17) 145 (10) 94 (6) 85% 62% 47% 52% 44% Foam Cream Gel Lo�on Solu�on Predicted compliance rate >75% for 12 weeks Rate the foam on each of the following quali�es: Moisturizing, lack of residue, does not feel greasy, absorbs quickly, easy to apply, fragrance-free, spreadability, lack of s�ckiness As can be seen below, the foam vehicle rated very strongly, largely as good or excellent, on all a�ributes. The excep�on being moisturizing, which is not surprising given that a number of subjects were ra�ng the ac�ve re�noid foam. For all skin medica�ons you have used in the past for acne, rate the following product types in the order you preferred them. The data show that the foam was rated by far the highest as first preference for treatment vehicle, with 51% of par�cipants ra�ng foam best. This is between 3 to 10 �mes greater than the number of those ra�ng other formula�ons best, with the next highest being cream at only 17% of subjects ra�ng it best. If you were asked by your doctor to put medica�on on your skin once daily for 12 weeks, how likely would you be to follow these instruc�ons based on the product type? The foam rated most strongly of all formula�ons, with 85% of par�cipants sta�ng that they would comply between 75-100% of the �me over a 12 week treatment course. 1. Ms. Schreiber and Ms. Crane are employees of Mayne Pharma. 2. Dr. Lewis is the Director of Clewy Communica�ons. 3. This analysis and presenta�on was sponsored by Mayne Pharma and prepared by Clewy Communica�ons. 4. Author Contact Informa�on: rhonda.schreiber@maynepharma.com Disclosures 0 10 20 30 40 50 60 70 80 90 100 PE RC EN T O F PA TI EN TS Excellent Good Fair Poor Very Poor Not Answered