Trial Outcomes & Findings for Safety for Frequent Use Conditions of Hair Removal Device (NCT NCT01348789)

Results Overview

The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2013-02-18

Participant Flow

The recruitment was conducted in a medical clinic. The recruitment continued from January to June 2011.

Participant milestones

Participant milestones
Measure	Hair2Go (Mē) Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
Overall Study STARTED	37
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Hair2Go (Mē) Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Safety for Frequent Use Conditions of Hair Removal Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hair2Go (Mē) n=37 Participants Treatment with Hair2Go (Mē)device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	32.5 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Population: Intention to treat analysis - all participants that received at least 1 treatment.

The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing \< 24 hours) or prolonged erythema * Presence of transient (disappearing \< 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.

Outcome measures

Outcome measures
Measure	Hair2Go (Mē) n=37 Participants Treatment with Hair2Go (Mē)device	Light Skin - Treat#2 Self assessment of tolerability for skin photo-type I-IV after treatment#2.	Light Skin - Treat#3 Self assessment of tolerability for skin photo-type I-IV after treatment#3.	Dark Skin - Treat#1 Self assessment of tolerability for skin photo-type V-VI after treatment#1	Dark Skin - Treat#2 Self assessment of tolerability for skin photo-type V-VI after treatment#2	Dark Skin - Treat#3 Self assessment of tolerability for skin photo-type V-VI after treatment#3
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. Anticipated skin effects	0 percentage of particpants Interval 0.0 to 9.5	—	—	—	—	—
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. Device related serious adverse events	0 percentage of particpants Interval 0.0 to 0.83	—	—	—	—	—
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. Device related adverse events	0 percentage of particpants Interval 0.0 to 9.5	—	—	—	—	—

SECONDARY outcome

Timeframe: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)

Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)

Outcome measures

Outcome measures
Measure	Hair2Go (Mē) n=86 Treatment areas Treatment with Hair2Go (Mē)device	Light Skin - Treat#2 n=82 Treatment areas Self assessment of tolerability for skin photo-type I-IV after treatment#2.	Light Skin - Treat#3 n=70 Treatment areas Self assessment of tolerability for skin photo-type I-IV after treatment#3.	Dark Skin - Treat#1 n=68 Treatment areas Self assessment of tolerability for skin photo-type V-VI after treatment#1	Dark Skin - Treat#2 n=68 Treatment areas Self assessment of tolerability for skin photo-type V-VI after treatment#2	Dark Skin - Treat#3 n=68 Treatment areas Self assessment of tolerability for skin photo-type V-VI after treatment#3
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. Moderate Pain	0 number of areas	0 number of areas	0 number of areas	5 number of areas	2 number of areas	2 number of areas
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. No Pain	82 number of areas	80 number of areas	70 number of areas	50 number of areas	53 number of areas	54 number of areas
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin. Mild pain	4 number of areas	2 number of areas	0 number of areas	13 number of areas	13 number of areas	12 number of areas

SECONDARY outcome

Timeframe: 8 weeks after last treatment

Hair Clearance = the percent of hair cleared from baseline to follow up

Outcome measures

Outcome measures
Measure	Hair2Go (Mē) n=71 Treated areas Treatment with Hair2Go (Mē)device	Light Skin - Treat#2 Self assessment of tolerability for skin photo-type I-IV after treatment#2.	Light Skin - Treat#3 Self assessment of tolerability for skin photo-type I-IV after treatment#3.	Dark Skin - Treat#1 Self assessment of tolerability for skin photo-type V-VI after treatment#1	Dark Skin - Treat#2 Self assessment of tolerability for skin photo-type V-VI after treatment#2	Dark Skin - Treat#3 Self assessment of tolerability for skin photo-type V-VI after treatment#3
Hair Clearance	44.19 %baseline hair count Standard Deviation 31.09 • Interval 37.1 to 51.3	—	—	—	—	—

Adverse Events

Hair2Go (Mē)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jerome M. Garden

Northwestern Memorial Hospital

Phone: 312-280-0891

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60