Remove unwanted hair
Conditions
Interventions
Experimental group:UI04 Ice Cooling IPL Hair Removal Device
Control group:Profile Laser/Intense Pulsed Light Therapy System
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged from 18 to 65 years (inclusive); 2. No hair removal by any method within the 6 months prior to treatment; 3. Hair removal site is one of the following: axilla, lower leg, or forearm; 4. No use of any oral medications that could affect blood clotting; 5. Agreement to refrain from any other hair removal treatments besides the trial treatment during the trial; 6. Voluntary signing of the informed consent form and agreement to participate in all visits, examinations, and treatments as required by the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Hirsutism caused by endocrine disorders; 2. Presence of significant liver or kidney disease, or ALT and AST levels exceeding 1.5 × ULN and Cr and UN levels exceeding ULN; 3. Patients with severe mental illnesses, hematological system diseases, neoplasm malignants, AIDS, or other serious conditions; 4. White blood cell count below 2.5 × 10^9/L; 5. Patients with open wounds or herpes or other active dermatoses like psoriasis; 6. Patients who have used photosensitizing medications within the past two weeks, or patients who are on prolonged hormone therapy due to illness; 7. Patients with a history of using anticoagulants and/or taking aspirin (> 325 mg); 8. Patients who have undergone laser treatment or cosmetic injections (e.g., whitening injections), or used retinoids within the past 6 months; 9. Scarring tendencies, prone to keloid scars or hypertrophic scars; 10. Women who plan to become pregnant, are pregnant, or are breastfeeding; 11. Light sensitivity or allergies to materials involved in this treatment; 12. Patients still participating in other clinical trials within the past 3 months; 13. Other situations deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall efficacy rate of hair removal at 3 months: the proportion of subjects showing cure, significant efficacy, and improvement at 3 months of treatment. The CBS-609 device is used to photograph the targeted treatment area and record the number of hairs.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The overall efficacy rate of hair removal at 1 month, 2 months, and 6 months after treatment.;Subjects' evaluation of satisfaction with treatment efficacy:;Evaluation of device usage;Incidence rate of adverse reactions.; | — |
Countries
China
Contacts
Public ContactZhenfeng Liu
Dermatology Hospital of Southern Medical University
Outcome results
None listed