The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design

Hair Removal Clinical Trial

Official title:

The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348776
• Other study ID #: OHR-2
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: April 2, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• Hair2Go (Me)
Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months

Locations

Country	Name	City	State
United States	Dr Jerome Garden	Chicago	Illinois
United States	Zel Skin and Laser Specialist	Edina	Minnesota
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	South Coast Dermatology	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Clearance 1 Month After Last Treatment	Hair clearance = the percent of hair cleared from baseline to endpoint.	3 months (1 month after 7 weekly treatments)	No
Secondary	Hair Clearance at 3-month (Final) Follow up	Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.	5 months (3 months after 7 weekly treatments)	No
Secondary	Occurrence of Anticipated Effects on Skin	As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.	Up to 19 weeks	Yes
Secondary	Tolerability Level of the Procedure Following Treatments	Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .; The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.	1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)	No
Secondary	Subject Satisfaction	Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.	5 months (final follow up)	No