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Efficacy and safety of Angelica and Safflower Spot Removal Essence for Melasma: A clinical trial

Registration number：

ITMCTR2024000284

Date of Last Refreshed on：

2024-08-22

Date of Registration：

2024-08-22

Registration Status：

Retrospective registration

Public title：

Efficacy and safety of Angelica and Safflower Spot Removal Essence for Melasma: A clinical trial

English Acronym：

Scientific title：

Efficacy and safety of Angelica and Safflower Spot Removal Essence for Melasma: A clinical trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Bai-lin Chen

Study leader：

Yuan-yuan Chen

Applicant telephone：

+86 188 1062 0199

Study leader's telephone：

+86 138 1173 6949

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2985823396@qq.com

Study leader's E-mail：

chenyuanyuan_001@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Beijing University of Chinese Medicine, Chaoyang District, Beijing, China

Study leader's address：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Haidian Disrict, Beijing, China

Applicant postcode：

100029

Study leader's postcode：

100039

Applicant's institution：

Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

ZXYEC-KT-2022-10-P01

Approved file of Ethical Committee：

View

Name of the ethic committee：

the Ethics Committee of Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Date of approved by ethic committee：

2022/4/7 0:00:00

Contact Name of the ethic committee：

Yu-na Liu

Contact Address of the ethic committee：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Haidian Disrict, Beijing, C

Contact phone of the ethic committee：

+86 88223667

Contact email of the ethic committee：

kjk88223667@163.com

Primary sponsor：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Primary sponsor's address：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Haidian Disrict, Beijing, C

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Address：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Haidian Disrict, Beijing, C

Source(s) of funding：

None

Target disease：

Melasma

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To analyze the efficacy and safety of Danghong Quban Essence for Melasm

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Ages between 18 to 60 years old; ② Meeting the Western medical diagnostic criteria for melasma; ③ Meeting the traditional Chinese medicine diagnostic criteria for the syndrome of Qi stagnation and blood stasis in melasma; ④ Have not undergone any related treatments for melasma in the past 3 months (such as oral administration of tranexamic acid, glycyrrhizic acid, vitamin C, vitamin E, glutathione, blood-activating and stasis-eliminating drugs, etc.; external use of skincare products containing whitening ingredients like tranexamic acid, arbutin, etc.; external use of hydroquinone ointment, arbutin ointment, azelaic acid, etc.); ⑤ Signed the informed consent form, willing to participate voluntarily and accept treatment.

Exclusion criteria：

① Individuals with severe internal organ diseases such as heart, lung, liver, kidney, and gastrointestinal disorders, as well as those with significant illnesses like immune system deficiencies and patients with psychiatric disorders, cancer patients currently undergoing radiotherapy, chemotherapy, immunotherapy, etc.; ② Pregnant and lactating women; ③ Individuals with skin in a state of severe allergy, pigmentation caused by other reasons, inflammatory reactions caused by external cosmetics, or inflammatory conditions such as acne, and those with facial wounds, ulcers, or herpes and other skin lesions; ④ Continuous use of corticosteroid medications, and vascular abnormalities caused by liver function abnormalities; ⑤ Individuals allergic to the ingredients of the red spot removing essence.

Study execute time：

From 2022-09-01

To      2023-02-28

Recruiting time：

From 2022-09-01

To      2022-12-31

Interventions：

50

Group：

Controlled group

Sample size：

Intervention：

Blank essence without traditional Chinese medicine solution

Intervention code：

50

Group：

Intervention group

Sample size：

Intervention：

Angelica and Safflower Spot Removal Essence

Intervention code：

Total sample size ： 100

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Safety assessment

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Physician's Global Assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Patient Self-Assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VISIA Analysis

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Melasma Area and Severity Index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

None

Tissue：

Fate of sample 

Others

Note：

Completed

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomized Number Table

Blinding：

Prepare placebos and experimental drugs with identical appearances. Based on the results of the random grouping, assign the corresponding drugs or intervention measures to the subjects while maintaining blinding. Throughout the research process, data collectors should remain blinded and not know the group information of the subjects. Regularly check the implementation of the blinding to ensure there is no information leak. Maintain blinding during the data analysis phase until the analysis is completed. After the study is concluded, unblind according to the predetermined procedure and disclose the group information of each group.

IPD sharing：

Yes

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

ResMan research manager

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

Use CRF (Case Report Form) for data collection, accurately enter the collected data into an EXCEL spreadsheet, and store images on a USB drive. Back up all data. Regularly perform data quality checks, including completeness, consistency, and accuracy of the data. Ensure the security and confidentiality of the data, complying with relevant data protection regulations. Control data access permissions to ensure that only authorized personnel can access the data. Ensure that the entire data collection and management process adheres to ethical guidelines and the rights of research participants.

Data Managemen Committee：

Yes

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

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