Unique ID issued by UMIN | UMIN000016692 |
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Receipt number | R000019359 |
Scientific Title | Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE) |
Date of disclosure of the study information | 2015/05/25 |
Last modified on | 2019/12/23 23:19:55 |
Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Adapalene vs. Placebo as Prophylaxis for anti-EGFRs-induced Acne-like rash, a Randomized left-right Comparative Evaluation (APPEARANCE)
Japan |
Cancer patients treated with an EGFR inhibitor
Gastroenterology | Pneumology | Hematology and clinical oncology |
Dermatology |
Malignancy
NO
To evaluate the efficacy and safety of prophylactic topical adapalene for acne-like rash induced by EGFR inhibitor in patients with cancers.
Safety,Efficacy
The difference (placebo side - adapalene side) of total acne-like lesion count at 4 weeks
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
2
Treatment
Medicine |
Adapalene gel 0.1% + skin moisturizers + minocycline
Placebo gel + skin moisturizers + minocycline
20 | years-old | <= |
Not applicable |
Male and Female
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
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.
30
1st name | Masanori |
Middle name | |
Last name | Toyoda |
Kobe University Hospital
Division of Medical oncology/Hematology
650-0017
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
078-382-5820
kobetoyo@med.kobe-u.ac.jp
1st name | Toru |
Middle name | |
Last name | Mukohara |
Kobe University Hospital
Cancer Center
650-0017
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
078-382-5820
mukohara@med.kobe-u.ac.jp
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine
Self funding
Institutional review board at Kobe University Hospital
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe, Hyogo, Japan
078-382-6669
chiken@med.kobe-u.ac.jp
NO
神戸大学医学部附属病院(兵庫県)
2015 | Year | 05 | Month | 25 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019359
Published
http://theoncologist.alphamedpress.org/content/24/7/885.long
36
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.
2019 | Year | 12 | Month | 23 | Day |
Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive ant-EGFR therapies
a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial.
Dry skin, Pruritus, Pain of skin, Erythema multiform
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
Main results already published
2015 | Year | 01 | Month | 30 | Day |
2015 | Year | 03 | Month | 25 | Day |
2016 | Year | 02 | Month | 08 | Day |
2017 | Year | 06 | Month | 26 | Day |
2015 | Year | 03 | Month | 03 | Day |
2019 | Year | 12 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019359
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