Tests on the use of skincare products during laser hair removal.

UMIN ID: UMIN000056016

Registered date:01/11/2024

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Patients presenting for laser hair removal on the face (beard) and lower legs.
• Date of first enrollment: 2023/01/23
• Target sample size: 25
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Skin care guidance, use of skin care products

Outcome(s)

• Primary Outcome: The study doctor will examine the subject at the beginning of the study, after oneweekandattheend of the study (after four weeks), assess and judge the following for each subject and enter them in the case card
• Secondary Outcome: At the end of the study (four weeks later) for each subject, the physician in charge of the study will assess the safety of the study on the basis of the occurrence of side effects in the following four levels and enter this assessment on a case card with commentsPhotography: In the case of facial (beard) hair removal, the face is photographed with a facial imaging device or digital camera at the start of the study, one week later and at the end of the study (four weeks later).In the case of hair loss on the anterior surface of the lower leg, photographs are taken with a digital camera.The condition of the pores is also photographed using a microscope as a magnified image.Skin measurements are taken at the start of the study, one week later and at the end of the study (four weeks later) at the examination.Both measuring instruments are not invasive to the skin as the measuring probes are in contact with the skin surface.Epidermal stratum corneum water content: stratum corneum water content is measured using a stratum corneum water content meter.Epidermal water transpiration: trans-epidermal water transpiration is measured using a trans-epidermal water transpiration meter.Sebum content (face only): measure sebum content using a sebum secretion meter.Skin colour: skin colour and L* (lightness), a* (redness), b* (yellowness), MI (melanin index) and EI (erythema index) are measured using a spectrophotometer.Stratum corneum assessment: a Sellotape is gently pressed on the face (forehead, cheeks and chin) or on the anterior aspect of the lower leg to collect the outermost layer of the stratum corneum.Fluorescence immunostaining, ELISA and enzyme assays are used to analyse skin bioactive substances related to inflammation, keratinisation and skin barrier function.Questionnaire survey: Questionnaires will be administered at the start of the study, after 1 week and at the end of the study (after 4 weeks).

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (i) Those with serious skin diseases.(ii) In principle, those who cannot be examinedafteroneweek and at the end of the study (after four weeks).(iii) Any other person who is judged by the study physician to be unsuitable to participate in the study.

Related Information

• Primary Sponsor: Takano Medical Clinic
• Source(s) of Monetary Support: Tokiwa Pharmaceutical Co. will provide appropriate skincare products. In addition, TokiwaPharmaceutical Industries, Ltd. will provide an honorarium at the end of the study.