UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016692
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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