Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials

References

• Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):1–10.
   PubMed Web of Science ®Google Scholar
• Skroza N, Tolino E, Mambrin A, et al. Adult acne versus adolescent acne: a retrospective study of 1,167 patients. J Clin Aesthet Dermatol. 2018;11(1):21–25.
   PubMedGoogle Scholar
• Gollnick HP, Zouboulis CC, Akamatsu H, et al. Pathogenesis and pathogenesis related treatment of acne. J Dermatol. 1991;18(9):489–499.
   PubMedGoogle Scholar
• Moradi Tuchayi S, Makrantonaki E, Ganceviciene R, et al. Acne vulgaris. Nat Rev Dis Primers. 2015;1:15029.
   PubMed Web of Science ®Google Scholar
• Foti C, Romita P, Borghi A, et al. Contact dermatitis to topical acne drugs: a review of the literature. Dermatol Ther. 2015;28(5):323–329.
   PubMed Web of Science ®Google Scholar
• Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther. 2017;7(3):293–304.
   PubMed Web of Science ®Google Scholar
• Nguyen HL, Yiannias JA. Contact dermatitis to medications and skin products. Clin Rev Allergy Immunol. 2019;56(1):41–59.
   PubMed Web of Science ®Google Scholar
• Dreno B, Thiboutot D, Gollnick H, et al. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol. 2010;49(4):448–456.
   PubMed Web of Science ®Google Scholar
• Sevimli Dikicier B. Topical treatment of acne vulgaris: efficiency, side effects, and adherence rate. J Int Med Res. 2019;47(7):2987–2992.
   PubMed Web of Science ®Google Scholar
• Kircik LH, Draelos ZD, Berson DS. Polymeric emulsion technology applied to tretinoin. J Drugs Dermatol. 2019;18(4):S148–S154.
   PubMed Web of Science ®Google Scholar
• Baldwin H, Webster G, Stein Gold L, et al. 50 Years of topical retinoids for acne: evolution of treatment. Am J Clin Dermatol. 2021;22(3):315–327.
   PubMed Web of Science ®Google Scholar
• Hoffman LK, Bhatia N, Zeichner J, et al. Topical vehicle formulations in the treatment of acne. J Drugs Dermatol. 2018;17(6):S6–S10.
   PubMedGoogle Scholar
• Tanghetti EA, Draelos ZD, Grimes P. Moisturizer use enhances facial tolerability of tazarotene 0.1% cream without compromising efficacy in patients with acne vulgaris. Poster presented at: Fall Clinical Dermatology, Las Vegas, NV, October 2008.
   Google Scholar
• Leyden JJ, Berger RS, Dunlap FE, et al. Comparison of the efficacy and safety of a combination topical gel formulation of benzoyl peroxide and clindamycin with benzoyl peroxide, clindamycin and vehicle gel in the treatments of acne vulgaris. Am J Clin Dermatol. 2001;2(1):33–39.
   PubMedGoogle Scholar
• Cunliffe WJ, Holland KT, Bojar R, et al. A randomized, double-blind comparison of a clindamycin phosphate/benzoyl peroxide gel formulation and a matching clindamycin gel with respect to microbiologic activity and clinical efficacy in the topical treatment of acne vulgaris. Clin Ther. 2002;24(7):1117–1133.
   PubMed Web of Science ®Google Scholar
• Leyden JJ, Wortzman M, Baldwin EK. Antibiotic-resistant propionibacterium acnes suppressed by a benzoyl peroxide cleanser 6%. Cutis. 2008;82(6):417–421.
   PubMed Web of Science ®Google Scholar
• Stein Gold L, Baldwin H, Kircik LH, et al. Efficacy and safety of a fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: a randomized phase 2 study of the first triple-combination drug. Am J Clin Dermatol. 2022;23(1):93–104.
   PubMed Web of Science ®Google Scholar
• Stein Gold L, Kircik LH, Tanghetti EA. 32970: Efficacy and safety of a fixed-dose clindamycin 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: randomized phase 2 and phase 3 studies of the first triple-combination drug. JAAD. 2022;87(3).
   PubMed Web of Science ®Google Scholar
• Jordan WP. 24-, 48-, and 48/48-hour patch tests. Contact Derm. 1980;6(2):151–152.
   PubMed Web of Science ®Google Scholar
• Berger RS, James PB. A reappraisal of the 21-day cumulative irritation test in man. J Toxicol, Cutan Ocul Toxicol. 1982;1(2):109–115.
   Google Scholar
• Stein Gold L, Kircik LH, Tanghetti EA, et al. Efficacy and safety of a fixed-dose clindamycin 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel for moderate-to-severe acne: randomized phase 2 and phase 3 studies of the first triple-combination drug. Poster presented at: American Academy of Dermatology Annual Meeting, Boston, MA, March 2022.
   Google Scholar
• Culp L, Moradi Tuchayi S, Alinia H, et al. Tolerability of topical retinoids: are there clinically meaningful differences among topical retinoids? J Cutan Med Surg. 2015;19(6):530–538.
   PubMed Web of Science ®Google Scholar
• Tanghetti EA, Stein Gold L, Del Rosso JQ, et al. Optimized formulation for topical application of a fixed combination halobetasol/tazarotene lotion using polymeric emulsion technology. J Dermatolog Treat. 2021;32(4):391–398.
   PubMed Web of Science ®Google Scholar
• Chou M, Mikhaylov D, Strugar TL. Common allergens present in personal care products: identification, diagnosis, and management. Semin Cutan Med Surg. 2018;37(4):254–262.
   PubMed Web of Science ®Google Scholar
• Goosens C. Cosmetic contact allergens. Cosmetics. 2016;3(1):5.
   Google Scholar
• Barnes TM, Mijaljica D, Townley JP, et al. Vehicles for drug delivery and cosmetic moisturizers: review and comparison. Pharmaceutics. 2021;13(12):2012.
   PubMed Web of Science ®Google Scholar
• Veraldi S, Brena M, Barbareschi M. Allergic contact dermatitis caused by topical antiacne drugs. Expert Rev Clin Pharmacol. 2015;8(4):377–381.
   PubMed Web of Science ®Google Scholar
• Dosik JS, Vamvakias G. Comparative irritation potential of two combination acne products: a randomized controlled, subject- and evaluator-blind, comparative study in healthy volunteers. Am J Clin Dermatol. 2008;9(5):313–317.
   PubMed Web of Science ®Google Scholar
• NDA-214902: US Food and Drug Administration; 2018. [cited 2022 November 1]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214902Orig1s000MultidisciplineR.pdf.
   Google Scholar
• Alexis AF, Harper JC, Stein Gold LF, et al. Treating acne in patients with skin of color. Semin Cutan Med Surg. 2018;37(3S):S71–S73.
   PubMedGoogle Scholar
• Bae-Harboe YS, Graber EM. Easy as pie (postinflammatory erythema). J Clin Aesthet Dermatol. 2013;6(9):46–47.
   PubMedGoogle Scholar
• Callender VD, Alexis AF, Daniels SR, et al. Racial differences in clinical characteristics, perceptions and behaviors, and psychosocial impact of adult female acne. J Clin Aesthet Dermatol. 2014;7(7):19–31.
   PubMedGoogle Scholar
• Layton A, Alexis A, Baldwin H, et al. Identifying gaps and providing recommendations to address shortcomings in the investigation of acne sequelae by the personalising acne: consensus of experts panel. JAAD Int. 2021;5:41–48.
   PubMedGoogle Scholar
• Del Rosso JQ, Schmidt NF. A review of the anti-inflammatory properties of clindamycin in the treatment of acne vulgaris. Cutis. 2010;85(1):15–24.
   PubMed Web of Science ®Google Scholar
• Stuart B, Maund E, Wilcox C, et al. Topical preparations for the treatment of mild-to-moderate acne vulgaris: systematic review and network meta-analysis. Br J Dermatol. 2021;185(3):512–525.
   PubMed Web of Science ®Google Scholar
• Tschen EH, Katz HI, Jones TM, et al. A combination benzoyl peroxide and clindamycin topical gel compared with benzoyl peroxide, clindamycin phosphate, and vehicle in the treatment of acne vulgaris. Cutis. 2001;67(2):165–169.
   PubMed Web of Science ®Google Scholar
• Thiboutot DM, Weiss J, Bucko A, et al. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol. 2007;57(5):791–799.
   PubMed Web of Science ®Google Scholar
• NDA-207917: US Food and Drug Administration; 2015. [cited 2022 November 8]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207917Orig1s000MedR.pdf.
   Google Scholar
• NDA-050819: US Food and Drug Administration; 2008. [cited 2022 November 8]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/050819s000_MedR.pdf.
   Google Scholar
• NDA-022320: US Food and Drug Administration; 2008. [cited 2022 November 1]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_MedR.pdf.
   Google Scholar