Pilot Study of a Novel IPL for Removal of Unwanted Fine Body Hair
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|ClinicalTrials.gov Identifier: NCT01912950|
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : September 11, 2015
The purpose of this randomized, controlled, open-label pilot study is to evaluate the safety and efficacy of a novel intense pulsed light (IPL) device for removal of unwanted fine body hair.
Subjects will have a designated treatment area on one forearm divided into four equal-size quadrants. One quadrant will serve as the un-treated control area and the other 3 quadrants will be treated with the Cutera Prowave LX IPL. Subjects will receive 3 IPL treatments, spaced 8 weeks apart, on the designated area and will be followed at 12-weeks post-final treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hypertrichosis||Device: Prowave LX IPL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled, Open-Label Pilot Study of a Novel IPL for Removal of Unwanted Fine Hair|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Prowave LX IPL
Prowave LX IPL, "short pulse" setting and snowflake mode "On"
Device: Prowave LX IPL
No Intervention: No Treatment
No treatment administered.
- Change from Baseline in Quantitative Hair Count at 12-weeks post-final treatment. [ Time Frame: 12-weeks post-final treatment ]
- Change from Baseline in Quantitative Hair Count at 8-weeks and 16-weeks. [ Time Frame: 8 weeks and 16 weeks ]
- Percent Hair Reduction at 12-weeks post-final treatment as compared to Baseline [ Time Frame: 12-weeks post-final treatment ]
- Average Subject Satisfaction Score [ Time Frame: 12-weeks post-final treatment ]Subjects will be asked to complete a questionnaire about the subject's satisfaction with the treatment results.
- Average Subject Discomfort during Treatment [ Time Frame: Day 0, 8 weeks and 16 weeks ]Subjects will be asked to rate the discomfort experienced during hair removal treatments using a 0 to 10 numeric scale.
- Number of Participants with Adverse Device Effects [ Time Frame: 12-weeks post final treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912950
|United States, New York|
|Sadick Research Group|
|New York, New York, United States, 10075|