UMIN-CTR Clinical Trial

Public title

A study of safety and efficacy of R410 for acne vulgaris.

Acronym

A study of safety and efficacy of R410 for acne vulgaris.

Scientific Title

A study of safety and efficacy of R410 for acne vulgaris.

Scientific Title:Acronym

A study of safety and efficacy of R410 for acne vulgaris.

Region

Japan

Condition

acne vulgaris

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the safety and efficacy of the two preparations with a different pH of R410 for acne vulgaris.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Percent reduction of the total acne lesion counts

Key secondary outcomes

-Percent reduction of the non-inflammatory lesion counts
-Decrease percentage of the inflammatory lesion counts
-Improvement level in the lesion counts
-Safety: Adverse event
-Assessment by subject

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

A preparation of R410 will be applied to the specified one-side face, in the morning and night after washing for 12 weeks.

Interventions/Control_2

Another preparation with a different pH of R410 will be applied to the other specified one-side face, in the morning and night after washing for 12 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

12

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Subjects with total acne (non-inflammatory and inflammatory) lesion more than 30 counts on the face (forehead, cheek, and jaw).
- 10 to 40 inflammatory lesions
- 20 non-inflammatory lesions or more
- 2 nodules/cysts or less
2)Subjects with acne lesions on both sides of face which are almost the same severity.
3)Subjects who understood the requirements of the study and signed the informed consent forms.

Key exclusion criteria

1.Subjects with clinically-significant disorder that might influence the outcome of this study.
2.Acne conglobata, acne fulminans, or secondary acne (e.g. chloracne, drug-induced acne).
3.Subjects for whom the systemic treatment of acne vulgaris is necessary.
4.Underlying diseases or skin symptoms (e.g. atopic dermatitis, perioral dermatitis, rosacea), with topical or systemic treatment which could interfere with the study assesment.
5.History of hypersensitivity to any components of the study preparations.
6.Change in the use of facial cleanser or skin care products for acne within the past 1 month.

7.Use of the following items within the specified washout period or during the study.

7.1 Topical preparations and therapy applied to the sites to be studied
1)Topical preparations
i)Use of the following preparations within the past 4 weeks.
-Retinoids
ii)Use of the following preparations within the past 2 weeks.
-Benzoyl Peroxide
-Corticosteroids
-Exfoliating products including hydroxy acids, except facial cleanser
2)Therapy etc.
i)Chemical peels, laser treatment, photo therapy, esthetic treatment, surgery of face.

7.2 Systemic drugs
1)Use of the following preparations within the past 12 weeks.
-Retinoids
2)Use of the following preparations within the past 4 weeks.
-Other acne treatments including antimicrobials etc. (except vitamin and cystein preparations)
-Corticosteroids
-Hormone preparations
-Kampo preparations likely to be effective for acne

8.Subjects who are improper to entry this study, with some complications, e.g. severe heart disease, renal disorder, hepatic disorder, respiratory disease, cardiovascular disease, immune disorder.
9.Female who is pregnant, trying to become pregnant (self- declared), during this study period, or breast feeding.
10.Participation in another clinical study within the past 3 months.
11.Subjects who are improper as the participant in the study in judgement of the principal or the other investigators.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Kawashima/Nobukazu Hayashi

Organization

Tokyo Woman's Medical University

Division name

Dermatology

Zip code

Address

8-1 Kawada-cho Shinjuku-ku, Tokyo 162-8666, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Rohto Pharmaceutical Co.,LTD.

Division name

Clinical Development Division, R & D

Zip code

Address

20F Shiomome Bldg., 1-2-20, Kaigan, Minato-ku, Tokyo 105-0222, Japan

TEL

Homepage URL

Email

Institute

Rohto Pharmaceutical Co.,LTD.

Institute

Department

Personal name

Organization

Rohto Pharmaceutical Co.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

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

2010

Year

05

Month

17

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

Completed

Date of protocol fixation

2010

Year

04

Month

22

Day

Date of IRB

Anticipated trial start date

2010

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

05

Month

14

Day

Last modified on

2010

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004385