CClinicalTrials.gg
Status unknownNCT04152707Updated Jul 2, 2021

Clinical Evaluation of Splendor X for Hair Removal

An interventional study of Splendor X in Hair Remval, sponsored by Lumenis Be Ltd.. Status unknown at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-02.

Sponsored by Lumenis Be Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hair Remval
03

In context

Lead sponsor

Lumenis Be Ltd. is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Splendor X

    Device: Splendor X

Interventions

  • DeviceSplendor X

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

06

What researchers measure

Primary outcomes

  1. Hair reduction

    change in number of hairs at 3 months following the last treatment as compared to baseline

    Time frame: 3 months follow up

07

Study locations

2 sites
  • SkinCare Physicians
    Boston, Massachusetts 02467, United States
  • Union Square Laser Dermatology
    New York, New York 10003, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04152707
Lead sponsor
Lumenis Be Ltd.
Responsible party
Sponsor
First posted
Nov 5, 2019
Start date
Jan 8, 2020
Primary completion
Mar 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
Jul 2, 2021

Study contacts

Thomas Rohrer, Dr.
principal investigator · SkinCare Physicians
Anne Chapas, Dr.
principal investigator · Union Square Laser Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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