UMIN-CTR Clinical Trial

Basic information
Public title	Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Acronym	Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Scientific Title	Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Scientific Title:Acronym	Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Region	Japan

Condition
Condition	Cancer patients treated with an EGFR inhibitor
Classification by specialty	Gastroenterology Pneumology Hematology and clinical oncology Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of prophylactic topical adapalene for acne-like rash induced by EGFR inhibitor in patients with cancers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference (placebo side - adapalene side) of total acne-like lesion count at 4 weeks
Key secondary outcomes	The investigator's global assessment by dermatologists at 4 weeks The incidence of grade2-3 rash acneiform (MASCC scale) of face within 4 weeks The time to appearance of rash acneiform The rate of complete control of rash acneiform The rate of adverse events The adherence of prophylactic treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adapalene gel 0.1% + skin moisturizers + minocycline
Interventions/Control_2	Placebo gel + skin moisturizers + minocycline
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who had histologically or cytologically confirmed malignancy 2) Patients who plan the treatment with EGFR inhibitor 3) Age >=20 years 4) ECOG performance status of 0,1,2 5) Fulfil all following conditions i) AST and ALT less than 2.5-times the upper limit of normal (If a patient have liver metastasis, AST and ALT less than 5-times the upper limit of normal) ii) Total-bilirubin 2.0 mg/dL or less 6) Written informed consent
Key exclusion criteria	1) Previous history of chemotherapy with anti EGFR antibody 2) Past history of severe allergic reaction or history of hypersensitivity or allergy for study drugs 3) Cutaneous symptom of the face 4) Patients receiving irradiation of the face 5) Complications or history of interstitial pneumonia, pulmonary fibrosis 6) Severe complications 7) Pregnancy, possible pregnancy or breastfeeding. 8) Unstable psychic disorder 9) Continuous systemic steroid treatment 10) Decision of ineligibility by a physician.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Toyoda
Organization	Kobe University Hospital
Division name	Division of Medical oncology/Hematology
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-5820
Email	kobetoyo@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Mukohara
Organization	Kobe University Hospital
Division name	Cancer Center
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-5820
Homepage URL
Email	mukohara@med.kobe-u.ac.jp

Sponsor
Institute	Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional review board at Kobe University Hospital
Address	7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019359
Publication of results	Published

Result
URL related to results and publications	http://theoncologist.alphamedpress.org/content/24/7/885.long
Number of participants that the trial has enrolled	36
Results	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 complete control rate of acne-like rash (<=5 facial lesions) (54% vs. 50%) or IGA scale (mean grade, 1.9 vs. 1.7) between the adapalene and placebo sides.
Results date posted	2019 Year 12 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive ant-EGFR therapies
Participant flow	a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial.
Adverse events	Dry skin, Pruritus, Pain of skin, Erythema multiform
Outcome measures	Primary Endpoint Left-right difference (the placebo side minus the adapalene side) in total rash count after 4 weeks of therapy Secondary Endpoints IGA scale after 4 weeks Incidence of grade >=2 acne-like rash based on the MASCC scale after 4 weeks Interval to the occurrence of acne-like rash based on patient diaries Complete control rate of acne-like rash defined as number of facial lesions <=5
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 30 Day
Date of IRB	2015 Year 03 Month 25 Day
Anticipated trial start date	2016 Year 02 Month 08 Day
Last follow-up date	2017 Year 06 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 03 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019359

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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