Clinical Evaluation of Splendor X for Hair Removal

June 30, 2021 updated by: Lumenis Be Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hair reduction
Time Frame: 3 months follow up
change in number of hairs at 3 months following the last treatment as compared to baseline
3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lumenis Be Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Rohrer, Dr., SkinCare Physicians
  • Principal Investigator: Anne Chapas, Dr., Union Square Laser Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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