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Clinical observation of marigold moisturizing spray and mask after pico1064nm

Registration number：

ITMCTR2100005473

Date of Last Refreshed on：

2021-12-30

Date of Registration：

2021-12-30

Registration Status：

Prospective registration

Public title：

Clinical observation of marigold moisturizing spray and mask after pico1064nm

English Acronym：

Scientific title：

Clinical observation of marigold moisturizing spray and mask after picoway

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100055009 ; ChiMCTR2100005473

Applicant：

Yao shanshan

Study leader：

Dong jiying

Applicant telephone：

18301792658

Study leader's telephone：

13917235344

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yaoshanshan_yss@163.com

Study leader's E-mail：

docdongjiying@163.com

Study leader's website(voluntary supply)：

上海交通大学医学院附属第九人民医院

Study leader's website
(voluntary supply)：

Applicant address：

639 Zhizaoju Road, Huangpu District, Shanghai, China

Study leader's address：

上海市黄埔区制造局路639号

Applicant postcode：

Study leader's postcode：

Applicant's institution：

上海交通大学医学院附属第九人民医院

Approved by ethic committee：

Approved No. of ethic committee：

SH9H-2021-T381-1

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the NO.9 People's Hospital, Shanghai Jiao Tong University School o

Date of approved by ethic committee：

2021/11/25 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

9th People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Primary sponsor's address：

639 Zhizaoju Road, Huangpu District, Shanghai, China

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Huangpu

Institution
hospital：

9th People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

639 Zhizaoju Road, Huangpu District, Shanghai, China

Source(s) of funding：

Self-financing

Target disease：

postoperative care after laser

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To observe the clinical effect of marigold moisturizing spray and mask after pico1064nm and evaluate its safety

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age from 18 to 65, no gender limitation (2) In good health, no history of serious diseases of cardiovascular system, digestive system, endocrine system, immune system, nervous system or other major diseases;No history of mental or psychological disorders (3) In line with the indications of pico1064nm treatment, such as acne scar, light aging, enlarged pores, etc (4) No skin barrier damage, no obvious telangiectasia, chloasma, etc (5) The subjects fully understand the test contents, voluntarily participate in the test, and have signed the informed consent form (6) No history of skin chemical peeling, other photoelectric treatment history, or participation in other clinical studies affecting the observation of this study within 3 months (7) No history of drug allergy, skin tumor, dermatitis, eczema and other skin diseases (8) Be able to conduct treatment, data collection and visit cooperation according to research requirements

Exclusion criteria：

(1) Known to be allergic to the active ingredients or excipients of the cosmetics under study (2) Facial skin with obvious signs of bacterial, fungal, viral or other pathogen infection, such as acne, folliculitis, herpes simplex, verruca plana, etc (3) Previous history of herpes simplex (4) During pregnancy, pregnancy and lactation (5) Those who use Chinese herbal medicine, sleeping sedatives or other addictive drugs (6) Alcoholics, patients with mental illness, or those who cannot cooperate with the treatment and researchers according to the doctor's advice (7) Patients with a history of photosensitive diseases (chronic actinic dermatitis, systemic lupus erythematosus, etc.), skin photoallergy, porphyrin allergy, porphyria, etc (8) Oral or external photosensitive drugs or hormones

Study execute time：

From 2021-11-01

To      2022-11-30

Recruiting time：

From 2021-12-24

To      2022-02-24

Interventions：

18

Group：

Group 2

Sample size：

Intervention：

Use mask after pico1064nm laser

Intervention code：

18

Group：

Group 1

Sample size：

Intervention：

Use marigold moisturizing spray and mask after pico1064nm laser

Intervention code：

Total sample size ： 36

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Institution/hospital：

NO.9 People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A Hospital

Outcomes：

Outcome：

Patient satisfaction

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

transepidermal water loss ( TEWL)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Adverse reaction rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

According to the order of patient visits, they are numbered and divided into 1 group according to the serial number. Random numbers 1-4 were randomly selected from the computer in each group. Those who received No. 1 and No. 3 entered the test group, and those who received No. 2 and No. 4.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Project data will be published in Shanghai Ninth People's Hospital 6 months after the completion of the trial.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All project data and CRF forms will be kept in Shanghai Ninth People's Hospital

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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