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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

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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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