Clinical Evaluation of Splendor X for Hair Removal

NCT04152707 | Unknown

• 1 other identifier: LUM-ABU-SPLENDOR X-2019-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Hair reduction

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

  3 months follow up

Study Arms (1)

Splendor X

EXPERIMENTAL

Device: Splendor X

Interventions

Splendor X DEVICE

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

Splendor X

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

SkinCare Physicians

Boston, Massachusetts, 02467, United States

Location

Union Square Laser Dermatology

New York, New York, 10003, United States

Location

Study Officials

• Thomas Rohrer, Dr.

  SkinCare Physicians

  PRINCIPAL INVESTIGATOR

• Anne Chapas, Dr.

  Union Square Laser Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 5, 2019
• Study Start: January 8, 2020
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (2)