Hair RemvalNCT04152707

Clinical Evaluation of Splendor X for Hair Removal

A study testing Splendor X in people with Hair Remval, run by Lumenis Be Ltd. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Hair Remval
What is being tested?: Splendor X
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 2 sitesUnited States
Study dates: 8 Jan 2020to Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to read, understand and provide written Informed Consent;
All skin types: I-VI
Male or female
Age - 18-50 years of age
Having one suitable treatment areas (legs, back, Chest or abdomen) with dark brown or black hair appropriate for hair removal;
Interested in laser hair removal treatment for permanent hair reduction in the suitable area
Able and willing to comply with the treatment/follow-up schedule and requirements;
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.

Who cannot join

Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
Participation in another clinical study
Active infections in the treated area;
Dysplastic nevi in the treatment area;
Tattoos in the treatment area;
Current cancer, history of skin cancer or pre-cancerous lesions at the treatment areas;

Show all 29Show fewer

History of keloid scars anywhere on the body or scar formation in the treatment area ; or at risk of Keloid scars
Active cold sores, open lacerations or abrasions in the treated area;
Herpes simplex in the treatment area
Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study
Significant concurrent skin conditions or any inflammatory skin conditions;
Chronic or cutaneous viral, fungal, or bacterial diseases;
Intense tan, Deep suntan, recent suntan within 2 weeks, sunburn or artificially tanned skin;
Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light or change skin metabolism
Skin lesions
Bleeding coagulopathies or use of anticoagulants
Hormonal disorders that may affect hair growth;
Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications; or other auto-immune dsorders.
Livedo reticularis;
Uncontrolled systemic diseases such as diabetes;
Use of Accutane™ (Isotretinoin) within the past 6 month;
Erythema ab igne, when identified treatments should be discontinued;
Photosensitivity disorder that can be exacerbated by laser or intense light (such as Epilepsy).
Poor wound healing;
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;
Previous skin procedures on requested treatment area (botox, fillers , peels , lasers etc. )
Mechanical or chemical hair removal in the treated area within 6 weeks before the laser treatment
Subjects who do not desire permanent hair reduction in the areas to be treated
As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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
Being tested: Splendor X

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04152707
Study group	Role	What they receive
Splendor X	Experimental	Not described Receives: Device: Splendor X

What is being measured

The primary outcome is the main question the study is designed to answer.

Hair reduction
change in number of hairs at 3 months following the last treatment as compared to baseline
Measured: 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 2020Apr 2023

First posted5 Nov 2019
Study start8 Jan 2020
Primary completionMar 2023 (estimated)
Study completionApr 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hair RemvalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 44 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04152707
Sponsor's protocol ID: LUM-ABU-SPLENDOR X-2019-01
Status last verified: Jun 2021
First submitted: 3 Nov 2019
Last updated: 2 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Splendor X for Hair Removal
ClinicalTrials.gov ID: NCT04152707
Acronym / sponsor ID: LUM-ABU-SPLENDOR X-2019-01
Conditions: Hair Remval
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 44 participants (estimated)
Lead sponsor: Lumenis Be Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jan 2020 (actual)
Primary completion: Mar 2023 (estimated)
Study completion: Apr 2023 (estimated)
First posted: 5 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Splendor X	Experimental	Device: Splendor X

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Able to read, understand and provide written Informed Consent;
All skin types: I-VI
Male or female
Age - 18-50 years of age
Having one suitable treatment areas (legs, back, Chest or abdomen) with dark brown or black hair appropriate for hair removal;

Key exclusion criteria (29 listed)

Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
Participation in another clinical study
Active infections in the treated area;
Dysplastic nevi in the treatment area;
Tattoos in the treatment area;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Splendor XThe Splendor X has two wavelengths in one system: Nd:YAG (1064nm) and Alexandrite (755nm).	Device	Splendor X

Primary outcome

Hair reduction
Time frame: 3 months follow up
change in number of hairs at 3 months following the last treatment as compared to baseline

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Rohrer, Dr. principal investigator

SkinCare Physicians

Anne Chapas, Dr. principal investigator

Union Square Laser Dermatology

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Splendor X in people with Hair Remval, run by Lumenis Be Ltd. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair reduction (time frame: 3 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04152707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.