Clinical trial NCT01348776: The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
Official title: The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal
Keywords: hair reduction
hair removal
hair clearance
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design.

Detailed description: This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair removal device and to compare the extent of hair removal with and without maintenance treatments. Preferably, two anatomical regions to be treated will be selected including the axilla and either the legs (calves) or forearms. The size of the area treated will be approximately 5x5 cm2. Additional areas including the face can be treated according to the subject's request with the PI's discretion but are not mandatory. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". The duration of the treatment session is approximately 30-60 minutes. Each of the selected anatomical regions (both left and right sides) will be treated with either low, medium, or high Elōs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elōs energy levels only. Only the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg will not be treated and will serve as a reference for the temporal changes in hair growth that might be subject to factors, including fluctuations in hormone levels. Both sides (left and right) of the same anatomical region will receive the basic treatments. One side will receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No maintenance" side) until the end of the experiment. More specifically, the study includes up to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be conducted at 4 and 12 weeks after the last basic treatment.

Eligibility criteria: Inclusion Criteria

1. Healthy males and females, between 18 and 65 years of age.
2. Subject has Black or dark brown terminal hairs in the areas to be treated.
3. Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
4. Willing to sign informed consent.
5. Willing to follow the treatment schedule and post treatment follow-up.
6. Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
7. Willingness to avoid excessive sun exposure two weeks prior to treatments

Exclusion Criteria

Skin and Hair

1. Subjects with white, red, light brown and/ or blonde hairs in the areas to be treated.
2. A history of keloidal scarring (hypertrophic scars or keloids).
3. Active dermatologic lesion or infection in the treatment site.
4. Subject has permanent tattoos or makeup in the treatment area.
5. Recently tanned in the area to be treated and/or unable or unlikely to refrain from tanning during the study.
6. Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
7. Subject has a history of herpes outbreak in the area of treatment, unless receiving preventative treatment from physician

   Other Medical Conditions
8. Pregnant, planning to become pregnant, hormone fluctuations and/or breast feeding during the experiment.
9. Subjects with Diabetes (Type I or II) or other systemic or metabolic condition
10. Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc.
11. Subject suffers from epilepsy.
12. Subject has active cancer, or has a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions.
13. Subject received radiation therapy or chemotherapy treatments with the past 3 months.
14. Subject has known anticoagulative or thromboembolic condition or is on any form of anticoagulation treatment.
15. Subject has a history of immunosuppressant/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
16. Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated.

    Medication/treatments
17. Subject had rotating type tweezer epilator treatment, or waxing within the last 3 weeks
18. Subject had electrolysis treatment within the last 6 months over the treatment area.
19. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site within the last 6 months.
20. Subject is taking medication known to induce photosensitivity, including non-steroidal anti-inflammatory agents, tetracyclines, phenothiazines, thiazide diuretics, sulfonylureas, sulfonamides, Dacarbazine(DTIC), fluorouracil, vinblastine, and griseofulvin within 4 weeks of therapy.
21. Subject has been taking Accutane® within 6 months of therapy.
22. Subject has been on steroid regimen during the last three months.
23. Subject is on Gold therapy (for arthritis treatment).

Primary outcomes:
measure: Hair Clearance 1 Month After Last Treatment
timeFrame: 3 months (1 month after 7 weekly treatments)
Secondary outcomes:
measure: Hair Clearance at 3-month (Final) Follow up
timeFrame: 5 months (3 months after 7 weekly treatments)
measure: Occurrence of Anticipated Effects on Skin
timeFrame: Up to 19 weeks
measure: Tolerability Level of the Procedure Following Treatments
timeFrame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
measure: Subject Satisfaction
timeFrame: 5 months (final follow up)
Other outcomes:
Locations:
city: Tustin
country: United States
facility: South Coast Dermatology
state: California
city: Chicago
country: United States
facility: Dr Jerome Garden
state: Illinois
city: Edina
country: United States
facility: Zel Skin and Laser Specialist
state: Minnesota
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
Study officials:
affiliation: Northwestern Memorial Hospital
name: Jerome M Garden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Coast Dermatology Institute
name: Vince Afsahi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbot Northwestern Hospital Center for Cosmetic Care
name: Brian D Zelickson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Clinical Research Center
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: