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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000016692 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | Cancer patients treated with an EGFR inhibitor | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
kobetoyo@med.kobe-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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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 |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |