Trial Outcomes & Findings for Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures (NCT NCT01285947)
NCT ID: NCT01285947
Last Updated: 2021-12-06
Results Overview
The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments. Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score.
COMPLETED
NA
20 participants
3 hours for all treatments in one visit
2021-12-06
Participant Flow
Participant milestones
| Measure |
Naive Subjects
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
|
Non-Naive Subjects
Subjects who have previously undergone energy-based dermatologic procedures in the past.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures
Baseline characteristics by cohort
| Measure |
Naive Subjects
n=10 Participants
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
|
Non-Naive Subjects
n=10 Participants
Subjects who have previously undergone energy-based dermatologic procedures in the past.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours for all treatments in one visitThe mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments. Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score.
Outcome measures
| Measure |
Naive Subjects
n=10 Participants
Subjects who have not previously undergone energy-based dermatologic procedures in the past.
|
Non-Naive Subjects
n=10 Participants
Subjects who have previously undergone energy-based dermatologic procedures in the past.
|
|---|---|---|
|
Pain Rated by Subjects
|
2.3 Units on a scale
Standard Deviation 1
|
2.2 Units on a scale
Standard Deviation 1.4
|
Adverse Events
Naive Subjects
Non-Naive Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place