UMIN-CTR Clinical Trial

Public title

Usefulness of Combination with Moisturizer in Nodular Prurigo Treatment

Acronym

Usefulness of Moisturizer in Prurigo Treatment

Scientific Title

Usefulness of Combination with Moisturizer in Nodular Prurigo Treatment

Scientific Title:Acronym

Usefulness of Moisturizer in Prurigo Treatment

Region

Japan

Condition

Nodular Prurigo

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objectives of this study are to evaluate the efficacy and safety of moisturizer in nodular prurigo patients. Nodular prurigo patients will topical application of steroid drugs (for 2 weeks), then will topical application of steroid drugs or steroid drugs with moisturizer for 6 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1) Evaluation of efficacy
<Evaluation of severity>
The severity of nodular prurigo will be evaluated in accordance with the 4 levels of criteria (none, mild, moderate and severe) for each indicator of the severity (keratinization, thickening, scraping and drying).
<Evaluation of itch>
The itch intensity of subjects will be evaluated in accordance with the visual analogue scale (VAS) and itch score (5 levels).
(2) Evaluation of safety
<Subjective and objective symptom>
Following things occurred in the study will be studied. Adverse event description, seriousness (mild, moderate and severe), date of onset, action taken for adverse event, outcome (process and date of confirmation of outcome) and causal relationship to the study drug (Yes or No).

Key secondary outcomes

Study type

Interventional

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

<Steroid-treated group>
The subjects will be randomized into 2 groups (right or left) after topical application of steroid drugs for 2 weeks (observation period), then will be applied steroid drugs for 6 weeks (treatment period).

Interventions/Control_2

<Moisturizer combination group>
The subjects will be randomized into 2 groups (right or left) after topical application of steroid drugs for 2 weeks (observation period).
After 2 week topical application of steroid and moisturizer in treatment period, the application of steroid will be discontinued and then moisturizer will be applied for another 4 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Patients aged over 20 years or older on the day of signing informed consent form.
(2) Sex: Either male or female,
Patient status: Inpatient or outpatient
(3) Patients with the ability to assent participation in this clinical study and sign informed consent form.
(4) Patients with the same levels of nodular prurigo on left and right arms or legs. Patients with two separated target areas in trunk can also participate in this study.

Key exclusion criteria

(1) Patients with itchy condition other than nodular prurigo
(2) Patients with ulcer, erosion and eczema caused by scratching in the target areas
(3) Patients who are associated with severe (rash areas with strong inflammation are over 10% of BSA) or very severe form of atopic dermatitis
(4) Patients with history of allergy to topical drugs
(5) Patients with the following concurrent diseases:
Clinically significant liver, kidney, heart, lungs or blood diseases that require hospitalization
(6) Patients with kidney failure or kidney dysfunction
(7) Patients who have participated in any clinical trial or clinical study within one month before clinical study starts
(8) Patients who are judged to be inappropriate as a subject by the investigator or subinvestigator for other reasons

Target sample size

5

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiki Miyachi

Organization

Kyoto University Hospital

Division name

Department of Dermatology

Zip code

Address

54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto Japan

TEL

075-751-3111

Email

kaba@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenji Kabashima

Organization

Kyoto University, Graduate School of Medicine

Division name

Department of Dermatology

Zip code

Address

54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto Japan

TEL

075-751-3111

Homepage URL

Email

kaba@kuhp.kyoto-u.ac.jp

Institute

Tokyo Medical and Dental University
Department of Dermatology
(main research institute)

Institute

Department

Personal name

Organization

Study group for establishment of pathophysiological analysis, diagnostic criteria and guideline in the refractory chronic prurigo and cutaneous pruritus.

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

01

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

01

Month

15

Day

Last follow-up date

2014

Year

12

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

22

Day

Last modified on

2015

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010997