Trial Outcomes & Findings for Cryo-Touch II for the Treatment of Wrinkles (NCT NCT01167140)

NCT ID: NCT01167140

Last Updated: 2024-01-24

Results Overview

* Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale * Safety success: the absence of a device-related serious adverse event (DSAE)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 42 participants
• Primary outcome timeframe: Up to 4 months
• Results posted on: 2024-01-24

Participant Flow

Participant milestones

Measure	Treatment Group
Overall Study STARTED	42
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment Group
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Cryo-Touch II for the Treatment of Wrinkles

Baseline characteristics by cohort

Measure	Group 1 n=42 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	52 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: All subjects treated were analyzed to the safety endpoint.

• Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale
• Safety success: the absence of a device-related serious adverse event (DSAE)

Outcome measures

Measure	Treatment Group n=41 Participants
Number of Participants With Effectiveness and Safety Success Effectiveness Success (n=36)	30 participants
Number of Participants With Effectiveness and Safety Success Safety Success (n=41)	41 participants

SECONDARY outcome

Timeframe: Baseline and up to 4 months

Population: Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.

• Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline

Outcome measures

Measure	Treatment Group n=36 Participants
Participants With One Point Improvement in Line Severity 7 days post-treatment	32 participants
Participants With One Point Improvement in Line Severity 60 days post-treatment	19 participants
Participants With One Point Improvement in Line Severity 90 days post-treatment	9 participants
Participants With One Point Improvement in Line Severity 120 days post-treatment	2 participants

SECONDARY outcome

Timeframe: Up to 4 months

Population: 5 subjects were excluded from effectiveness analysis because they received a lower dose.

• Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline

Outcome measures

Measure	Treatment Group n=36 Participants
Participants With an Improvement in Global Appearance 7 days post-treatment	34 participants
Participants With an Improvement in Global Appearance 30 days post-treatment	32 participants
Participants With an Improvement in Global Appearance 60 days post-treatment	25 participants
Participants With an Improvement in Global Appearance 90 days post-treatment	12 participants
Participants With an Improvement in Global Appearance 120 days post-treatment	2 participants

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Group n=41 participants at risk
Nervous system disorders headache	9.8% 4/41 • Number of events 4
Skin and subcutaneous tissue disorders local side effect	22.0% 9/41 • Number of events 9

Additional Information

Francis Rogers Palmer III, MD

Myoscience

Phone: 650-474-2600

Email: thenry@myoscience.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER