A Chemical peeling safety and efficacy test

JRCT ID: jRCTs031230071

Registered date:15/05/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy adult
• Date of first enrollment: 18/05/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): chemical peeling

Outcome(s)

• Primary Outcome: Safety assessment
• Secondary Outcome: Instrumental skin measurement/Stratum Corneum examination/ visual observation/ photograph evaluation /skein tone color scale/Microscope observation/Satisfaction survey after using test product

Key inclusion & exclusion criteria

• Age minimum: > 20age old
• Age maximum: < 70age old
• Gender: Female

Include criteria

1)Those who have expressed their willingness to participate in the study, understood the explanation, and agreed in writing to participate in the study
2)Healthy Japanese women between the ages of 20 and 70 who wish to improve solar lentigines, freckle spots, chloasma, so-called dullness, and who do not meet the exclusion criteria, regardless of the presence or absence of diseases such as pigment spots
3)Those who can fill in documents such as consent forms, questionnaires, usage diaries, etc.
4)Those who can come to the facility on the designated observation day

Exclude criteria

1)Subjects who are likely to be exposed to sunlight during the test period (daytime sports, etc.)
2)Subjects who are strongly aware of sensitive skin
3)Those who have experienced allergic symptoms due to cosmetics etc
4)Subjects with skin symptoms such as atopic dermatitis, seborrheic eczema, and vitiligo, and those with a history of them
5)Subjects with coagulation disorder, immune disorder, facial herpes, severe acne, eczema, etc.
6)Those with severe hay fever
7)Subjects with a history of serious liver disorder, renal disorder, or myocardial infarction
8)Those who are pregnant or during the study period, those who may become pregnant, and those who are breastfeeding
9)Subjects who received facial, high-frequency treatment, injection treatment, etc. within 3 months from the start of the study
10)Those who participated in other clinical trials, research, etc. within 6 months of the start of the trial
11)Those who plan to participate in other clinical trials during the trial period
12)Subjects with skin symptoms not suitable for chemical peeling on the face
13)In addition, those who have symptoms that should be excluded by the attending physician or responsible physician

Related Information

• Primary Sponsor: Nogita Toshitatsu
• Source(s) of Monetary Support: MT Cosmetics Co.,Ltd.