N/A
N=20
Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01285947 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Pain Rated by Subjects — 2.3; 2.2 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Thermage (Device); Needle Application (Other); VBeam Laser (Device); Ulthera (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Rated by Subjects |
2.3; 2.2 | — |
Summary
The purpose of this study is to compare the pain experience of patients who have not had dermatologic procedures (previously "unexposed") using energy devices (lasers, radiofrequency, ultrasound, etc.) with patients who have previously had procedures (previously "exposed") using energy devices. Based on previous clinical encounters, individuals with no prior experience with cosmetic procedures appear to experience more pain. However, no study to date has thoroughly examined this observation. As a result, this study has been designed to find a possible difference in pain perception between previously exposed and unexposed patients undergoing cosmetic procedures using energy devices.
Eligibility Criteria
Inclusion Criteria
- Subjects of both genders, 18 to 65 years of age.
- Subjects who are in good health.
- Non-naïve (patients who have not had cosmetic procedures using energy devices): Subjects who have had three or more non-ablative laser procedures or any skin tightening procedure using an energy device.
- Subjects who understand and are willing to provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion Criteria
- Subjects who have an active skin disease or skin infection in or around the treatment.
- Subjects who are unable to understand the protocol or give informed consent.
- Subjects with photophobia or who are unable to tolerate the treatments.
Data sourced from ClinicalTrials.gov (NCT01285947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.