UMIN-CTR Clinical Trial

Public title

Clinical effect of R610 for retinoic acid induced dermatitis.

Acronym

Clinical effect of R610 for retinoic acid induced dermatitis.

Scientific Title

Clinical effect of R610 for retinoic acid induced dermatitis.

Scientific Title:Acronym

Clinical effect of R610 for retinoic acid induced dermatitis.

Region

Japan

Condition

solar lentigo

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate of R610 anti-inflammatory effect on retinoic acid induced dermatitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Degrees of dermatitis (erythema, edema, crust, drying, desquamation, feeling of stimulation, burning sensation, itching, irritation)

Key secondary outcomes

Efficacy
-Skin symptom score
-Hemoglobin index
-Subject impression
Other
-Melanin index
-Degree of skin tone color scale

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

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

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Twice a day (morning and evening).
After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic acid preparation to pigmented area, and, apply the R610 to the same pigmented area.
Treatment period;
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and R610 for 8 weeks.

Interventions/Control_2

Twice a day (morning and evening).
After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic acid preparation to pigmented area, and, apply the vehicle only to the same pigmented area.
Treatment period;
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and vehicle for 8 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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Subjects who have more than 2 counts of solar lentigo (each is over 5 mm in diameter) on the face, which are separated more than 1 cm from each other.
2. Subjects who understood the requirements of the study and signed the informed consent forms.

Key exclusion criteria

1. Subjects with rash, contact dermatitis, skin inflammation e.g. sunburn, and other skin abnormality.
2. Subjects with the following treatment history at baseline.
2.1 Treatment region
1)Topical preparations
i)Within the past 12 weeks
-Retinoic acid, adapalene
ii)Within the past 2 weeks
-Anti-inflammatory drugs (corticosteroid, nonsteroidal anti-inflammatory drug)
2)Other therapy
i)Within the past 4 weeks
-Chemical peelings, laser treatment, photo-therapy, plastic surgery treatment.
2.2 Systemic drugs, supplements
i)Within the past 12 weeks
-Retinoic acid
ii)Within the past 4 weeks
-Corticosteroid
3. Subjects with skin viral infection e.g. flat wart, herpes simplex.
4. Subjects who changed face cleanser or skin care products for the test regions within the past 2 weeks.
5. Subjects who exposed to the ultraviolet rays of the sun.
6. Subjects with systemic diseases, e.g. severe heart disease, renal disease, hepatic disease, respiratory disease, cardiovascular disease, and immune disease.
7. Subjects with atopic dermatitis or have a history of atopic dermatitis.
8. Subjects who had experience the contact dermatitis caused by the use of hydroquinone.
9. Females who are pregnant, trying to become pregnant (self-declared), during this study period, or breast feeding.
10. Participants of another clinical study within 4 months of study initiation.
11. Subjects who are improper as a participant in this study in judgement by the principal or other investigators.

Target sample size

16

Name of lead principal investigator

1st name
Middle name
Last name	Kotaro Yoshimura

Organization

University of Tokyo, School of Medicine

Division name

Plastic Surgery

Zip code

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 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 Shiodome Bldg., 1-2-20, Kaigan, Minato-ku, Tokyo, 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

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

07

Month

08

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

06

Month

11

Day

Date of IRB

Anticipated trial start date

2010

Year

07

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

07

Month

06

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=R000004665