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A prospective, single center, completely randomized, paired controlled, non inferiority controlled clinical trial evaluating the efficacy and safety of strong pulse light therapy equipment (models: BRI800/07, BRI800/09) for epilation

A prospective, single center, completely randomized, paired controlled, non inferiority controlled clinical trial evaluating the efficacy and safety of strong pulse light therapy equipment (models: BRI800/07, BRI800/09) for epilation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079423
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-19
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilation

Interventions

Group A:The energy of using the testing instrument on one side is 3 levels (3.24 ± 0.65J/cm) 2), On the other side, a control device is used
Group B:The energy level of the experimental instrument used on one side is 5 levels (4.88 ± 0.98J/cm2), while the control instrument is used on the other side

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: [1] The age of the subjects is between 18 and 45 years old (including 18 and 45 years old); [2] Chinese women with good skin and mental health conditions; [3] Skin color meets Pantone color code P90 and below; [4] More than or equal to 30 hairs in the experimental area of armpits and calves; [5] Suitable skin area for hair removal (upper lip, armpits, and calves); [6] Voluntary participation in this clinical trial, understanding and willing to sign an informed consent form; [7] Willing to comply with all testing requirements.

Exclusion criteria

Exclusion criteria: [1] Pregnant, breastfeeding, or women of childbearing age who have not used medically effective contraceptive methods, or those who plan to conceive during the trial period; [2] Visually inspect the hair color of the test area to see if it is golden or light colored (such as white or transparent); [3] People with skin allergy or photosensitive constitution, or people who have recently taken photosensitive food, drugs (such as celery, isotretinoin, tetracycline and sulfa), or people who are allergic to water-soluble gel; [4] Any active implantable device implanted in the body (such as a pacemaker, neural stimulator, or insulin pump, etc.) [5] Previous diagnosis with a history of hypertension or heart disease; [6] Individuals with keloids or hypertrophic scars; Individuals with scar constitution; [7] Individuals with suspected skin tumor lesions; [8] Excessive exposure to sunlight, artificial tanning, or skin tone of brownish black or darker color within the first 4 weeks of treatment; [9] Within 6 months prior to the start of the study, individuals who have used any hair removal treatment, skin whitening products within 1 month, or cosmetics containing vitamin A at the test site; [10] History of malignant tumors, folliculitis, skin diseases, burned skin, and anticoagulant disorders, or other medications that affect hemostasis; [11] Have been exposed to direct sunlight or sunbathing within the three months prior to the start of the study; [12] Individuals with immunosuppressive diseases (including lupus erythematosus and Yellowia); [13] Individuals with infections, related skin diseases (such as herpes zoster), and hematomas in the experimental treatment area; [14] The skin in the treatment area has been treated with fruit acid (AHA), salicylic acid (BHA), topical isotretinoic acid, and rhododendron acid currently or within the past 2 weeks; [15] Individuals with any bleeding disorder (such as skin purpura); [16] Suffering from vascular diseases, such as varicose veins and vasodilation at the treatment site; [17] Individuals with photosensitive epilepsy; [18] Previously diagnosed with local or systemic skin infectious diseases or infectious diseases such as hepatitis and syphilis; [19] Open tearing or abrasion in the treatment area; [20] Individuals who are taking vasodilators, anti joint pain medications, aspirin, immunosuppressive agents, or taking isotretinoids; [21] Subjects who have participated in clinical trials or are currently participating in other clinical trials within the three months prior to the start of this study (excluding observational/non-interference studies); [22] Other situations that researchers believe are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
efficient;

Secondary

MeasureTime frame
Overall improvement;Satisfaction;Pain level;Safety assessment;

Countries

China

Contacts

Public ContactWang Xi

West China Hospital, Sichuan University

xierwang@126.com+86 28 8542 2075

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026