Adapalene Gel 0.1% Versus Placebo as Prophylaxis for Anti-Epidermal Growth Factor Receptor-Induced Acne-Like Rash: A Randomized Left-Right Comparative Evaluation (APPEARANCE)

Author:

Chayahara Naoko1,Mukohara Toru12,Tachihara Motoko3,Fujishima Yoshimi14,Fukunaga Atsushi5,Washio Ken5,Yamamoto Masatsugu3,Nakata Kyosuke3,Kobayashi Kazuyuki3,Takenaka Kei1,Toyoda Masanori1,Kiyota Naomi12,Tobimatsu Kazutoshi4,Doi Hisayo6,Mizuta Naomi7,Marugami Naho7,Kawaguchi Atsushi8,Nishigori Chikako5,Nishimura Yoshihiro3,Minami Hironobu12

Affiliation:

1. Division of Medical Oncology and Hematology, Kobe University Graduate School of Medicine, Kobe, Japan

2. Division of Cancer Center, Kobe University Hospital, Kobe, Japan

3. Division of Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan

4. Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan

5. Division of Dermatology, Department of Internal related, Kobe University Graduate School of Medicine, Kobe, Japan

6. Department of Nursing, Kobe University Hospital, Kobe, Japan

7. Department of Hospital Pharmacy, Kobe University Hospital, Kobe, Japan

8. Education and Research Center for Community Medicine, Faculty of Medicine, Saga University, Saga, Japan

Abstract

Abstract Lessons Learned The results of the APPEARANCE trial indicate that adapalene does not prevent acne-like rash over placebo when added to topical moisturizer and oral minocycline but instead may have a detrimental effect. Therefore, adapalene is not recommended as prophylaxis against acne-like rash induced by anti-epidermal growth factor receptor therapies. Given that acne-like rash was completely controlled with placebo in approximately half of patients, predictive measures to identify patients needing intensive prophylaxis are required. Background Anti-epidermal growth factor receptor (EGFR) therapies are frequently associated with acne-like rash. To evaluate the prophylactic efficacy of adapalene, a topical retinoid used as first-line therapy for acne vulgaris, we conducted a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial. Methods Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies were randomly assigned to once-daily adapalene application on one side of the face, with placebo on the other side. All patients had topical moisturizer coapplied to both sides of the face, and received oral minocycline. The primary endpoint was the difference in total facial lesion count of acne-like rash at 4 weeks. Secondary endpoints included complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0–4) at 4 weeks. Two blinded dermatologists independently evaluated the endpoints from photographs. Results A total of 36 patients were enrolled, of whom 26 were evaluable. Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8, p = .12). All four patients with a difference >10 in lesion count between face sides had a greater count on the adapalene-treated side. No significant differences were observed in CCR of acne-like rash (54% vs. 50%) or IGA scale (mean grade, 1.9 vs. 1.7) between the adapalene and placebo sides. Conclusion Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

Reference13 articles.

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