Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types VI Using Intense Pulsed Light

• Sponsor: Venus Concept (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02452398
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Duration (Months): 27.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Removal of Excess or Unwanted Body Hair	Device: Treatment group; Other: No intervention	N/A

Detailed Description

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::

• Two small anatomical areas (right and left axillae and double sided bikini line) or;

• One double sided large area (right and left thighs) or;

• One large area (whole back / abdomen)

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Hair Removal and Permanent Hair Reduction for Skin Types V-VI Using Intense Pulsed Light
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 27, 2017
• Actual Study Completion Date: Apr 18, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Hair removal treatment using Venus Versa IPL energy	Device: Treatment group; 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.; Other: No intervention; Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.
Placebo Comparator: 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; Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.

Outcome Measures

Primary Outcome Measures

1. Hair Count 6 Months Following Last Treatment [6 months after 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Able to read, understand and provide written Informed Consent;

2. Subject has black or dark brown terminal hairs in the areas to be treated.

3. 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.

4. Healthy adult, male or female, 21 years of age or older with skin type V-VI;

5. Having a suitable treatment area for hair removal;

6. Able and willing to comply with the treatment/follow-up schedule and requirements;

7. 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.

Exclusion Criteria:

1. Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;

2. Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);

3. Hormonal disorders that may affect hair growth;

4. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;

5. Livedo reticularis;

6. Uncontrolled systemic diseases such as diabetes;

7. Active infections in the treated area;

8. Dysplastic nevi;

9. Significant concurrent skin conditions or any inflammatory skin conditions;

10. Active cold sores, open lacerations or abrasions;

11. Chronic or cutaneous viral, fungal, or bacterial diseases;

12. Current cancer;

13. History of skin cancer or pre-cancerous lesions at the treatment areas;

14. Use of Accutane™ (Isotretinoin) within the past six month;

15. Keloid or Hypertrophic scar formation in the treatment area;

16. Tattoos in the treatment area;

17. Bleeding coagulopathies or use of anticoagulants;

18. Auto-immune disorders;

19. Erythema abigne, when identified treatments should be discontinued;

20. Photosensitivity disorder that can be exacerbated by laser or intense light;

21. Herpes simplex in the treatment area;

22. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;

23. Poor wound healing;

24. Sunburns;

25. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a month) and during the course of the evaluation;

26. Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology and Laser Centre	Manhattan Beach	California	United States	90266

Sponsors and Collaborators

• Venus Concept

Investigators

• Study Director: Tracey L Mancuso, Venus Concept

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 3, 2015

More Information

Publications

None provided.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT02452398
• Other Study ID Numbers: CS0115
• First Posted: May 22, 2015
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Venus Concept: Hair removal; depilation; epilation

Study Results

Participant Flow

Recruitment Details	The study was terminated and no results analysis was done.

Arm/Group Title	Treatment Group
Arm/Group Description	Hair removal treatment using Venus Versa IPL energy Venus Versa: The Venus Versa system is a multi-application device intended to be used in aesthetic and cosmetic procedures. The device consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated. The applicator that will be used for this study (HR 690) has a wavelength of 690 nm and has a spot size (treatment area) of 30 mm by 10 mm. IPL gel: water based gel used to protect the skin during light based treatments. Also used during ultrasound treatments.
Period Title: Overall Study
STARTED	79
COMPLETED	38
NOT COMPLETED	41

Baseline Characteristics

Arm/Group Title	Hair Removal With Versa HR 690nm Applicator
Arm/Group Description	Subjects with Fitzpatrick skin type V-VI requesting hair removal (right and left axillae and double sided bikini line) or one double sided large area (right and left thighs) or one large area (whole back / abdomen).
Overall Participants	79
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	79 100%
>=65 years	0 0%
Sex/Gender, Customized (Count of Participants)
Unknown	79 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	79 100%
Hair count in marked treatment area (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Hair Count 6 Months Following Last Treatment
Description	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

Outcome Measure Data

Analysis Population Description

This primary outcome measurement could not be reported as data were not collected.

Arm/Group Title	Treatment Group
Arm/Group Description	Enrolled subjects acted as their own control. Each received Venus Versa IPL treatment to remove hair in marked treatment area.
Measure Participants	0

Adverse Events

Time Frame	The adverse event data was collected over a period of 2 years and 2 months.
Arm/Group Title	Hair Removal With Versa HR 690nm Applicator
Arm/Group Description	All subjects who received at least one hair removal treatment with the Versa HR 690 nm applicator.
All Cause Mortality
	Hair Removal With Versa HR 690nm Applicator
	Affected / at Risk (%)	# Events
Total	0/79 (0%)
Serious Adverse Events
	Hair Removal With Versa HR 690nm Applicator
	Affected / at Risk (%)	# Events
Total	0/79 (0%)
Other (Not Including Serious) Adverse Events
	Hair Removal With Versa HR 690nm Applicator
	Affected / at Risk (%)	# Events
Total	0/79 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.