Clinical Evaluation of Splendor X for Hair Removal

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hair Remval
• Intervention / Treatment: Device: Splendor X

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02467
      • SkinCare Physicians
  • New York
    • New York, New York, United States, 10003
      • Union Square Laser Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Splendor X	Device: Splendor X; The Splendor X has two wavelengths in one system: Nd:YAG (1064nm) and Alexandrite (755nm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair reduction	change in number of hairs at 3 months following the last treatment as compared to baseline	3 months follow up

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Thomas Rohrer, Dr., SkinCare Physicians; Principal Investigator: Anne Chapas, Dr., Union Square Laser Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 3, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LUM-ABU-SPLENDOR X-2019-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No