Clinical Evaluation of Splendor X for Hair Removal

NCT ID: NCT04152707

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2023-04-30

Brief Summary

At least 40 healthy male or female subjects that wish to remove their hair will be enrolled to this study.

Each subject will receive five treatments at 6-8 weeks intervals. Subjects will return for follow-up visits at 3, 6, 9, and 12 months after the last treatment.

Conditions

Hair Remval

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Splendor X

Group Type: EXPERIMENTAL

Splendor X

Intervention Type: DEVICE

The Splendor X has two wavelengths in one system: Nd:YAG (1064nm) and Alexandrite (755nm).

Interventions

Splendor X

The Splendor X has two wavelengths in one system: Nd:YAG (1064nm) and Alexandrite (755nm).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to read, understand and provide written Informed Consent;

2. All skin types: I-VI

3. Male or female

4. Age - 18-50 years of age

5. Having one suitable treatment areas (legs, back, Chest or abdomen) with dark brown or black hair appropriate for hair removal;

6. Interested in laser hair removal treatment for permanent hair reduction in the suitable area

7. Able and willing to comply with the treatment/follow-up schedule and requirements;

8. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.

Exclusion Criteria

1. Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);

2. Participation in another clinical study

3. Active infections in the treated area;

4. Dysplastic nevi in the treatment area;

5. Tattoos in the treatment area;

6. Current cancer, history of skin cancer or pre-cancerous lesions at the treatment areas;

7. History of keloid scars anywhere on the body or scar formation in the treatment area ; or at risk of Keloid scars

8. Active cold sores, open lacerations or abrasions in the treated area;

9. Herpes simplex in the treatment area

10. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study

11. Significant concurrent skin conditions or any inflammatory skin conditions;

12. Chronic or cutaneous viral, fungal, or bacterial diseases;

13. Intense tan, Deep suntan, recent suntan within 2 weeks, sunburn or artificially tanned skin;

14. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light or change skin metabolism

15. Skin lesions

16. Bleeding coagulopathies or use of anticoagulants

17. Hormonal disorders that may affect hair growth;

18. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications; or other auto-immune dsorders.

19. Livedo reticularis;

20. Uncontrolled systemic diseases such as diabetes;

21. Use of Accutane™ (Isotretinoin) within the past 6 month;

22. Erythema ab igne, when identified treatments should be discontinued;

23. Photosensitivity disorder that can be exacerbated by laser or intense light (such as Epilepsy).

24. Poor wound healing;

25. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least 6 week) and during the course of the evaluation;

26. Previous skin procedures on requested treatment area (botox, fillers , peels , lasers etc. )

27. Mechanical or chemical hair removal in the treated area within 6 weeks before the laser treatment

28. Subjects who do not desire permanent hair reduction in the areas to be treated

29. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Rohrer, Dr.

Role: PRINCIPAL_INVESTIGATOR

SkinCare Physicians

Anne Chapas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Union Square Laser Dermatology

Locations

SkinCare Physicians

Boston, Massachusetts, United States

Union Square Laser Dermatology

New York, New York, United States

Countries

United States

Other Identifiers

LUM-ABU-SPLENDOR X-2019-01

Identifier Type: -

Identifier Source: org_study_id