NCT02452398

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 3, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

May 8, 2015

Results QC Date

April 9, 2018

Last Update Submit

October 15, 2020

Conditions

Removal of Excess or Unwanted Body Hair

Keywords

Hair removaldepilationepilation

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after last treatment

Study Arms (2)

Treatment Group

EXPERIMENTAL

Hair removal treatment using Venus Versa IPL energy

Device: Treatment groupOther: No intervention

No intervention

PLACEBO COMPARATOR

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

Interventions

Treatment groupDEVICE

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.

Treatment Group
No interventionOTHER

Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.

No interventionTreatment Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read, understand and provide written Informed Consent;
  • Subject has black or dark brown terminal hairs in the areas to be treated.
  • Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
  • Healthy adult, male or female, 21 years of age or older with skin type V-VI;
  • Having a suitable treatment area for hair removal;
  • Able and willing to comply with the treatment/follow-up schedule and requirements;
  • Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.

You may not qualify if:

  • Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
  • Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months);
  • Hormonal disorders that may affect hair growth;
  • Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
  • Livedo reticularis;
  • Uncontrolled systemic diseases such as diabetes;
  • Active infections in the treated area;
  • Dysplastic nevi;
  • Significant concurrent skin conditions or any inflammatory skin conditions;
  • Active cold sores, open lacerations or abrasions;
  • Chronic or cutaneous viral, fungal, or bacterial diseases;
  • Current cancer;
  • History of skin cancer or pre-cancerous lesions at the treatment areas;
  • Use of Accutaneâ„¢ (Isotretinoin) within the past six month;
  • Keloid or Hypertrophic scar formation in the treatment area;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology and Laser Centre

Manhattan Beach, California, 90266, United States

Location

Limitations and Caveats

The study was terminated due to slow recruitment (over 2 years and the target enrollment had not been reached).

Results Point of Contact

Title
Yoni Iger
Organization
Venus Concept Ltd
yoni@venusconcept.com
888-907-0115

Study Officials

  • Tracey L Mancuso

    Venus Concept

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 22, 2015

Study Start

January 1, 2015

Primary Completion

March 27, 2017

Study Completion

April 18, 2017

Last Updated

November 3, 2020

Results First Posted

November 3, 2020

Record last verified: 2020-10

Locations

US(1)