Patients presenting for laser hair removal on the face (beard) and lower legs.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects are patients who have visited the Takano Medical Clinic or Sawano Clinicforlaserhairremoval on the face (beard) or anterior lower leg, who are judged by the physician in charge of the study to have no problems withparticipation inthestudybased on skin findings and medical interview, and who areSubjects are patients who have visited the Takano Medical Clinic orSawano Clinic forlaserhairremoval on the face (beard) or anterior lower leg, who are judged by the physician in charge of the study to have no problems withparticipation inthestudybased on skin findings and medical interview, and who are(i) Adults aged 18 years or older (ii) Male subjects for facial (beard)hair removal,andgender-neutral subjects for leg hair removal (iii) Subjects who have been fully informed about the study, fully understand it and givetheir freeandvoluntarywritten consent to participate.In addition, there are no restrictions on treatment in cases where the subject has a diseaseother than askindisease (other diseases).
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
TOKIWA Pharmaceutical Co., Ltd. NOV Academic Research