Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris
NCT ID: NCT02924428
Last Updated: 2020-11-09
Study Results
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View full resultsBasic Information
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TERMINATED
NA
47 participants
INTERVENTIONAL
2016-09-30
2018-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Venus Versa
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.
Venus Versa
Interventions
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Venus Versa
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Venus Concept
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph L Reiz
Role: STUDY_DIRECTOR
Venus Concept Ltd.
Locations
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Sadick Research Group
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CS2715
Identifier Type: -
Identifier Source: org_study_id