Evaluation of Diolaze XL Blended Mode for Hair Removal

Clinical Evaluation of Diolaze XL Blended Mode for Hair Removal

The objective of this clinical study is to evaluate safety and efficiency of Diolase XL blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and 810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled. Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4 weeks apart and follow-up after 3 months.

Study Overview

• Status: Completed
• Conditions: Hair Removal
• Intervention / Treatment: Device: Diode laser

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Yokneam, Israel, 20692
    • InMode MD Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adult females between the ages of 18-65, seeking hair removal treatments.
• Subjects skin type II-V.
• Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
• Subjects should be willing to comply with the study procedure and schedule, including the follow up visit, to refrain from using any other aesthetic treatment methods in the treatment areas such as other hair removal methods (wax, IPL, laser), Botox or other technologies for hyperhidrosis or rejuvenation for the last 6 months and during the entire study period and to remain unshaven for a minimum of 3 days before their visit.

Exclusion Criteria:

• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
• Pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• Known skin photosensitivity or using drugs increasing skin photosensitivity.
• Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
• Six months delay is recommended if other recent treatments like light, laser or RF were performed on the same area.
• Treating over tattoo and permanent make-up.
• Fresh tan from sun, sunbeds or chemicals or planned excessive sun exposure.
• Vitiligo.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair reduction	Hair reduction of at least 30% at follow-up visit comparing to baseline count.	3 months follow-up
Recording of frequency, severity and causality of adverse events (Safety)	Observation, assessment and recording of reactions by the investigator.	3 months follow-up

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Study Director: Hela Goren, Ph.D., InMode MD Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): February 10, 2018

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 18, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: DO607227A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No