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

Stopped early · Not applicable

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02924428

Run by

Venus Concept

People needed

47

Starts

2016-09-01

Expected to finish

2018-10-01

Last updated by the study team

2020-11-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sadick Research Group — New York, New York, United States

Full record on ClinicalTrials.gov

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