UMIN-ICDS Clinical Trial

Public title

A study to examine the effects of medical makeup on patients with facial disorders who suffer from visible differences

Acronym

A study to examine the effects of medical makeup on patients with visible differences

Scientific Title

A study to examine the effects of medical makeup on patients with facial disorders who suffer from visible differences

Scientific Title:Acronym

A study to examine Effects of medical makeup

Region

Japan

Condition

Cleft lip, vascular and lymphatic malformations in the face, facial burns, facial trauma, patients after resection of head and neck malignant tumors

Classification by specialty

Plastic surgery	Adult	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

For patients suffering from visible differences after medical and dental treatment for facial diseases such as cleft lip, vascular/lymphatic malformations, facial burns, and resection of head and neck malignant tumors. We will verify whether medical makeup treatment and guidance can help solve patients' worries, and we will also consider the factors that affect the effect.
Specific efficacy measures include subjective self-esteem scales used psychologically, such as depression index, self-awareness scale, self-esteem scale, and self-efficacy scale, and patient-reported outcomes for patients with cleft lip. CLEFT-Q is used to evaluate the psychological changes of patients before and after medical makeup treatment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

(1) Evaluation items and their rationale
It is necessary to evaluate the impact of medical makeup on patient psychology from various aspects, and we selected existing reliable evaluation methods for self-denial and self-affirmation as evaluation items.
Depression coefficient was adopted as an evaluation item of self-denial. This coefficient is known to show a high value in patients suffering from Visible Difference. Therefore, the effect of medical makeup can be measured by improving the depression coefficient.
Self-awareness scale, self-esteem scale, and self-efficacy scale were adopted as scales for evaluating self-affirmation. These are assumed to be low in patients suffering from Visible Diffrence, and if improvement is obtained by medical makeup, it will be possible to measure the effect of supporting the patient's positive feelings.
In addition, for cleft lip CLEFT-Q is currently used worldwide and can assess psychological, school, and social function. Currently, the Japanese version is also published, and we have already obtained permission to use it.
(2) Evaluation period
An important point of view is whether the effect will end in the short term or will extend over the medium to long term. For this reason, we set six months, which is a relatively medium- to long-term period, instead of just before the operation, immediately after the operation, and one month after the operation.

Key secondary outcomes

In this study, the medical makeup treatment background, that is, the makeup artist and the number of treatments cannot be unified. Therefore, the makeup artist and the number of treatments are also evaluated as factors that affect the effect. At the same time, a psychologist who attends the make-up artist conducts descriptive analysis and records the words and actions of the makeup artist during the treatment.
In addition, we will examine whether the effect of medical makeup is affected by the research subject's background, and consider the application of appropriate medical makeup.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Make-up instruction by medical make-up specialists. Evaluate the changes after the instruction, targeting before the instruction.

Interventions/Control_2

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

6

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Disease
Cleft lip, vascular and lymphatic malformations in the face, facial burns, facial trauma, patients after resection of head and neck malignant tumors
(2) Age
School children must be 6 years old or older (at the time of registration), but minors must have parental consent and be present
(3)Gender
Male and Female
(4) Others
Patients who requested medical makeup and visited a plastic surgery counseling outpatient clinic.
Those who have given their written consent to participate in research.

Key exclusion criteria

(1) Patients for whom another social, psychological, or neuropsychiatric problem was pointed out in pre-counseling by a certified psychologist
(2) Patients whose reason for requesting medical makeup is not found to be reasonable in pre-counseling by a certified psychologist
(3) Patients who have a history of allergy to cosmetics or who have had an allergic reaction
(4) Patients scheduled for additional surgery in the future
(5) Young patients who cannot obtain sufficient informed assent
(6) Adult patients who are objectively judged to be incapable of giving informed consent

Target sample size

50

Name of lead principal investigator

1st name	IMAI
Middle name
Last name	YOSHIMICHI

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

980-8575

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

+81-22-717-7332

Email

yo-imai@med.tohoku.ac.jp

Name of contact person

1st name	Sato
Middle name
Last name	Akimitsu

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Plastic and Reconstrutive Surgery

Zip code

980-8575

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

+81-22-717-7332

Homepage URL

Email

akimitsu@med.tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB in Tohoku University Graduate School of Medicine

Address

2-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-728-4105

Email

med-kenkyo@grp.tohoku.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学病院　（宮城県）

Date of disclosure of the study information

2023

Year

08

Month

01

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

2023

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2023

Year

10

Month

01

Day

Last follow-up date

2028

Year

09

Month

30

Day

Date of closure to data entry

2028

Year

10

Month

31

Day

Date trial data considered complete

2028

Year

10

Month

31

Day

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

13

Day

Last modified on

2023

Year

08

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058876