An interventional study of Treatment group and No intervention in Removal of Excess or Unwanted Body Hair, sponsored by Venus Concept. Terminated at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Venus Concept · Not applicable, Interventional, and Treatment
This is a Multi-center, blinded, baseline-controlled, prospective study to evaluate permanent hair reduction and removal for skin types V and VI using IPL.
One hundred and twenty (120) subjects who are Fitzpatrick Skin Type V-VI, and have a suitable treatment area for hair removal will be evaluated in this study.
Each subject will receive six treatments at four to six week intervals upon re-growth of hair and return for follow-up visits at one, three and six months after the last treatment.
Measurement Equipment Standard High Resolution Digital Camera
Labels for hair count Customized hair count sticker templates will be placed directly on the skin and the hairs in this window will be counted at specific visits during the study as detailed in section.
Study Procedures Each subject will participate in the study for a period of at least 11 months. The study is anticipated to be completed within twelve months.
Test spots Up to 3 test spots will be performed in the selected treatment area to determine the optimal parameters / setting.
Treatment
The treatment areas are divided into 3 groups. Each Subjects will be allocated to one of the following groups::
Based on the mild nature of treatment, anesthesia is not required. Before starting treatment apply a layer of conductive gel to the treatment area.
After applying the conductive gel, locate the applicator in close contact, perpendicular to the skin with no pressure applied. Pressing the applicator will fire the IPL pulse. In order to ensure full coverage of the treatment area applicator placement should overlap approximately 1/3 of the previously treated skin.
Post-treatment Instructions Cold packs may be placed on the treated area for post treatment cooling. Subjects should be aware that post treatment erythema, edema and some discomfort of the treated areas are possible and should not be a cause for concern. They may also experience some purpura in the treated areas which would be expected to resolve within several days.
Venus Concept is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hair removal treatment using Venus Versa IPL energy
Device: Treatment group · Other: No intervention
Subject hair count at baseline will act as the control to which the hair count at 6 months after the last treatment.
Other: No intervention
The intense pulsed light (IPL) applicator with a wavelength of 690 nm and spot size (treatment area) of 30 mm by 10 mm will be used to deliver the energy to the treatment area.
Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.
Hair Count 6 Months Following Last Treatment
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
Time frame: 6 months after last treatment
The study was terminated and no results analysis was done.
| Milestone | Treatment Group |
|---|---|
| Started | 79 |
| Completed | 38 |
| Not completed | 41 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 28 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Moved away | 4 |
Hair count reduction in marked treatment area assessed from photographs taken 6 months following the last treatment as compared to photographs of the marked treatment area taken at baseline.
No measurements were reported for this outcome.
Collected over The adverse event data was collected over a period of 2 years and 2 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hair Removal With Versa HR 690nm Applicator | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
Data were not collected.
| Age, Categorical(Participants) | Hair Removal With Versa HR 690nm Applicator |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 79 |
| >=65 years | 0 |
| Sex/Gender, Customized(Participants) | Hair Removal With Versa HR 690nm Applicator |
|---|---|
| Unknown | 79 |
| Race (NIH/OMB)(Participants) | Hair Removal With Versa HR 690nm Applicator |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 79 |
| Hair count in marked treatment area(Participants) | Hair Removal With Versa HR 690nm Applicator |
|---|---|
| Count of participants | 0 |
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