Evaluation of Diolaze XL Blended Mode for Hair Removal

Hair Removal Clinical Trial

Official title:

Clinical Evaluation of Diolaze XL Blended Mode for Hair Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438929
• Other study ID #: DO607227A
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: February 10, 2018

Study information

• Verified date: February 2018
• Source: InMode MD Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 10, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• Diode laser
Diolaze XL blended modes diode laser

Locations

Country	Name	City	State
Israel	InMode MD Ltd.	Yokneam

Sponsors (1)

Lead Sponsor	Collaborator
InMode MD Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

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