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A study on the efficacy, safety, and satisfaction of hair removal treatment using blended 755 nm/1064 nm laser photoepilation system. (ALPS-study) (ALPS-study)

A study on the efficacy, safety, and satisfaction of hair removal treatment using blended 755 nm/1064 nm laser photoepilation system. (ALPS-study) (ALPS-study)

Nishikawa Ayaka

Shonan Beauty Clinic Skin Lab Shinjuku

7th Floor, Nishi-Shinjuku Daikyo Building, 7-21-3 Nishi-Shinjuku, Shinjuku-ku, Tokyo

a.nishikawa@sbc.or.jp

Ushijima Rina

SBC Medical Group

3rd Floor, Shinjuku Iland Tower, 6-5-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo

+81-50-5865-5940

8094ushijima@sbc.or.jp

Recruiting

Nov. 26, 2024

Interventional

randomized controlled trial

single blind

active control

parallel assignment

health services research

1) Those who wish to remove hair in the axilla.
2) Those who are between the ages of 18 and 50 fall under skin type ii-iv(Fitzpatrick Skin type classification) (regardless of gender)
3) Those who are able to visit the outpatient clinic according to the research schedule.
4) Those who are able to prevent both natural and artificial sunburn in the treatment areas during the research period.
5) Those who can comply with the guidelines associated with conducting research.
6) Those who have received sufficient explanation for participating in this research and have obtained written consent of their own free will after sufficient understanding.

1) Patients with high photosensitivity
2)Patients undergoing drug treatment to amplify the photosensitivity of the skin
3) Sites with herpes simplex lesions
4) Open wounds, infected skin
5) Areas with tattoos or permanent makeup
6) Dysplastic nevus or sites suspected of pigmented lesions
7) Those who with no hair growth or fine vellus hair
8) Those who have undergone the following hair removal before obtaining consent
Those who have undergone mechanical hair removal (laser or needle) within 6 months
Those who have removed hair with wax, hair removal, or hair removal agent within 2 weeks
9)Those who have been treated with isotretinoin within six months
10)Those who have hormonal disorders
11)Other patients who are judged by the principal investigator or co-investigator to be inappropriate to participate in this research

Both

Healthy subjects

Adults who wish to remove their hair are subjected to a medical hair removal machine, and laser treatment is performed on the left and right sides of the axilla using two different technologies of the same machine. In the case of men who wish to remove hair on the chin, laser treatment is performed on the left and right sides of the axilla and chin using two different technologies of the same machine.

The difference in hair reduction ratereduction rate between the side of the axillary side using Technology A (alexandrite) and the side using Technology B (alexandrite + YAG) compared to the time before laser treatment (hereinafter referred to as "baseline") at 9 months after the end of the final treatment.

1)The difference in hair reduction rates between the groups using Technology A and Technology B on the axillary side, comparing baseline measurements with each treatment session and 3 months after the final treatment
2) The difference in hair reduction rates between the groups using Technology A and Technology B in the chin, comparing baseline measurements with each treatment session, at the end of the final treatment, and 3 and 9 months after treatment completion.
3) The difference in hair reduction rates between the A technology group and the B technology group at the targeted areas of the chin and axilla, compared to the previous visit, before each treatment session, and 3.9 months after the final treatment.
4) The hair reduction rates for both Technologies A and B compared to baseline measurements in each area, before each treatment session, and 3 and 9 months after treatment completion.
5)The hair reduction rates for each area of the A and B groups, compared to the previous visit, before each treatment session, and 3.9 months after the completion of treatment.
6)Summary statistics and inter-group differences regarding pain experienced during the procedure (performed after each procedure) based on a questionnaire to the subjects
7)Summary statistics and inter-group differences of post-treatment satisfaction based on questionnaires to subjects (immediately after the end of treatment ~ after each visit 3 and 9 months after the end of treatment)

+81-3-3470-3360

Nov. 21, 2024

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