Evaluation of Diolaze XL Blended Mode for Hair Removal

NCT03438929 | Completed

• 1 other identifier: DO607227A
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hair Removal

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Diode laser DEVICE

Diolaze XL blended modes diode laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (1)

InMode MD Ltd.

Yoqneam, 20692, Israel

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Hela Goren, Ph.D.

  InMode MD Ltd.

  STUDY DIRECTOR

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: February 12, 2018
• First Posted: February 20, 2018
• Study Start: August 14, 2017
• Primary Completion: January 30, 2018
• Study Completion: February 10, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-02

Locations

IL (1)