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Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02924428
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Venus Concept

Brief Summary:
The purpose of the study is to evaluate the efficacy of facial acne vulgaris treatment using the Venus Versa Diamondpolar applicator in combination with the Venus Versa AC dual applicator using two intense pulsed light wavelength bands.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Venus Versa Not Applicable

Detailed Description:

Multi-center, prospective, open-label study utilizing before-after study design. Up to 20 healthy subjects, age 18 - 55 years with acne vulgaris who wish to improve their skin appearance will be randomized to receive either Diamondpolar applicator (radio frequency and pulsed magnetic field) treatment followed by AC Dual applicator (intense pulsed light) treatment or AC Dual applicator (intense pulsed light) treatment alone using the Venus Versa system. Duration of subject participation will be approximately 10 weeks (4 weekly treatments with a follow-up visit scheduled 6 weeks after the last treatment).

The AC Dual applicator (IPL) is indicated for the treatment of acne vulgaris by using a blue light (415 nm) to target porphyrins produced by the P. acne bacteria, destroying the bacteria and uses the red light (630 nm) to help reduce inflammation, inhibit sebum production and improve healing.

The addition of the Diamondpolar applicator (RF and PEMF) treatment is thought to target the sebaceous gland, causing it to shrink and decrease sebum output


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Venus Versa Diamonpolar Applicator Treatment Followed by AC Dual Applicator Treatment Using 2 Intense Pulsed Light Wavelength Bands for Facial Acne Vulgaris
Study Start Date : September 2016
Actual Primary Completion Date : June 5, 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Diamondpolar applicator, AC Dual applicator

Radio frequency (RF) and pulsed magnetic field (PEMF) treatment followed by intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.

The RF and PEMF applicator has 4 electrodes which emit RF and PEMF simultaneously.

The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.

Device: Venus Versa
Active Comparator: AC Dual applicator treatment

Intense pulsed light (IPL) treatment delivered to the skin using the Venus Versa system.

The IPL applicator operates a blue light (415 nm) and also red light (630 nm) simultaneously. The IPL applicator also includes a sapphire cooled light guide of 10x30mm.

Device: Venus Versa



Primary Outcome Measures :
  1. Improvement in treatment area appearance as determined by a blinded reviewer. [ Time Frame: Week 10 (6 weeks after last treatment) ]
    Treatment will be considered successful if the appearance improves by at least 2 points on the 5-point Global Acne Assessment Score (GAAS) at 6 weeks as compared to baseline.


Secondary Outcome Measures :
  1. Reduction of inflammatory lesions and non-inflammatory lesions [ Time Frame: Week 10 (6 weeks after last treatment) ]
    Reduction in number of lesions counted on treatment area

  2. Subject improvement assessment in treatment area appearance [ Time Frame: Week 10 (6 weeks after last treatment) ]
    Improvement evaluated by Global Aesthetic Improvement Scale (GAIS) at 6 weeks after last treatment as compared to baseline.

  3. Subject assessment of pain and discomfort associated with treatments [ Time Frame: Week 1, 2, 3 and 4 (immediately after each applicator treatment completed) ]
    Pain and discomfort evaluated by subject using the 100 mm Visual Analog Scale where 0 mm is 'no pain' and 100 mm is 'intolerable pain'.

  4. Subject satisfaction with treatment outcome [ Time Frame: Week 10 (6 weeks after last treatment) ]
    Satisfaction evaluated by subject using a 5-point Likert Scale.

  5. Subject assessment of improvement in 'quality of life' [ Time Frame: Week 1, 2, 3 and 4 and week 10 ]
    Quality of life questionnaire



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fitzpatrick skin phototype I - VI
  • Having mild to moderate acne vulgaris (as defined by the Acne Global Severity Scale) and have at least 10 inflammatory and 15 non-inflammatory lesions, but no nodulo-cystic lesions.
  • Subject who can commit to all treatments and follow up.

Exclusion Criteria:

  • Superficial metal or other implants in the treatment area.
  • Current or history of cancer, or current condition of any type of cancer, or pre-malignant moles.
  • Pregnancy and nursing.
  • Patients with cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc)
  • Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.
  • Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
  • Poorly controlled endocrine disorders, such as Diabetes or Polycystic Ovary Syndrome.
  • Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash.
  • Tattoos, scars or piercings in the treated area.
  • History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.

    • Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last six months, tetracyclines, or St. John's Wort within the last two weeks.

  • Any surgical procedure in the treatment area within the last three months or before complete healing.
  • Treating over tattoo or permanent makeup.
  • Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
  • As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
  • Exposure to investigational product within 3 months (or designated half-life) prior to enrollment.
  • Prior drugs, interventions, skin laser/light or another device for Acne treatment within 3 months of initial treatment or during the course of the study.

Information from the National Library of Medicine

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): NCT02924428


Locations
United States, New York
Sadick Research Group
New York, New York, United States, 10075
Sponsors and Collaborators
Venus Concept
Investigators
Study Director: Joseph L Reiz Venus Concept Ltd.

Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT02924428     History of Changes
Other Study ID Numbers: CS2715
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Venus Concept:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases